DAILY RELEVANT REGULATORY NEWS
Supporting biopharmaceutical Research and Development for EuropeThe European Commission, through its Health Emergency Preparedness and Response Authority (HERA) and in cooperation with the European Investment Bank (EIB), has signed a first investment agreement under the HERA Invest initiative to support biopharmaceutical research and development in Europe. Under this agreement, the French biopharmaceutical company Fabentech will receive €20 million in financing. The funds will be used to develop and produce therapeutic antibodies against biological health threats such as pandemics, antimicrobial resistance and other threats. Read more
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ICH E11A: Final version publishedIn August, the final guideline “ICH E11A Guideline on pediatric extrapolation” was published on the ICH website in the “efficacy guidelines” section. It is seen as a supplement to the guideline “ADDENDUM TO ICH E11: CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION E11 (R1)” and is due to come into force in January 2025. Read more
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EMA: Update of the Q&A Documents for "Centralised Procedures"In October 2024, the Questions & Answers (Q&A) documents relating to centralised marketing authorisation procedures - for topics before and during the application as well as for questions after the granting of marketing authorisation - were again updated and published on the website of the European Medicines Agency (EMA). Read more
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GMP Requirements for Ready to Sterilize (RTS) and Ready to Use (RTU) ContainersCurrently, there is a growing interest in the supply of GMP pre-sterilized packaging material (e.g. ready-to-sterilize (RTS), ready-to use (RTU) products). However, suppliers are facing new GMP requirements (e.g. regarding validation of the sterilization procedure) which apply with the revised EU GMP Annex 1 entitled “Manufacture of Sterile Medicinal Products”, which provides guidance on the approaches to sterilization of products, equipment and packaging components. Read more
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EMA updates Question and Answer Document on Combination ProductsCombinations of medicinal products and medical devices (medicinal product/drug-medical device combinations) are a challenging regulatory issue. After all, these products have to comply with both medicinal product regulations (e.g. GMP) and medical device and IVD regulations (e.g. ISO 13485). For this reason, guidance on these products from the authorities is very helpful. A Q&A document published by the European Medicines Agency (EMA) on this topic is updated continuously. It focuses on quality-related issues relating to these products in the context of authorisation. Below are some notes on the latest update. Read more
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MHRA: New Rules for Manufacturers and Wholesalers after BrexitThe UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published new guidance for pharmaceutical manufacturers and wholesalers in order to implement the arrangements of the Windsor Framework for human medicines. This will further widen the gap between the EU and the UK. Read more
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Commission welcomes international declaration on the fight against antimicrobial resistanceThe Commission welcomes the Political Declaration reached today at the United Nations General Assembly (UNGA) to step up action against antimicrobial resistance (AMR). At the High-Level ministerial meeting in New York, UN member countries, including EU Member States, and the EU committed to concrete actions to address AMR across all sectors, through a One Health approach that acknowledges that human, animal and environmental health are intrinsically linked. Read more
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What is RCA (Root Cause Analysis)?Root Cause Analysis (RCA) is an important part in CAPA processes in the pharmaceutical industry. RCA is a structured approach to the investigation process that aims to determine the underlying cause of a detected nonconformity or other undesirable situation. By identifying and eliminating the root cause, CAPA processes can prevent the recurrence or occurrence of quality problems and improve product and process performance. Read more
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How to document a Product Transfer? Get Example TemplatesAccording to the European GMP rules, written procedures for transfer activities and their documentation are required. For example, a Transfer SOP, a transfer plan and a report are now mandatory and might be checked during inspections. Read more
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EMA publishes Comments on ICH E2DThe European Medicines Agency (EMA) has published an overview of comments on the revised ICH E2D guidance on definitions and standards of post-authorization safety data. Read more
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EMA/CHMP: New Guideline Draft on Active Substances published for CommentAs reported, the 'Concept paper on the revision of the guideline on the chemistry of active substances' of the Quality Working Party (QWP) was published for comment in 2022. This document was intended to explain and clarify the need to revise and update the 'Guideline on the chemistry of active substances (EMA/454576/2016)' and to outline the procedure for the revision. The results and insights gained from this were incorporated into the revision of the guideline, with the result that the draft of Revision 1 of the 'Guideline on the chemistry of active substances' was published in July 2024. This draft is now open for public comment until the end of January 2025. Read more
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The Effectiveness of Disinfectant Agents: An OverviewDisinfectants play an important role in contamination control. It is not always easy to recognise which agents or active substances have which advantages and disadvantages. You can find a brief overview of the different groups of active substances in this short, clear summary. Read more
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ECA Guidance on Visual Inspection of ParenteralsParticipants of the ECA Conference Visual Inspection of Parenterals in Berlin (Germany) on 6/7 November 2024 will receive the latest version of ECA's Guidance Document on Visual Inspection of Parenterals. Read more
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EMA/CMDh: Q&A Document Nitrosamines revisedIn July 2024, the nitrosamine Q&A document "Nitrosamines EMEA-H-A5(3)-1490 - Questions and answers for marketing authorization holders / applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" of the EMA/CMDh was revised again and published on the EMA website under "Questions and answers". Read more
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How to document a Product Transfer? Get Example TemplatesAccording to the European GMP rules, written procedures for transfer activities and their documentation are required. For example, a Transfer SOP, a transfer plan and a report are now mandatory and might be checked during inspections. Read more
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EU Commission releases "Assessment of the Supply Chain Vulnerabilities for the first Tranche of the Union List of critical Medicines"On 10 July 2024, the European Commission's Health Emergency Preparedness and Response Authority (HERA) published a technical report evaluating vulnerabilities in the supply chain for medicines listed in the Union list of critical medicines. It is expected to provide valuable insights to the Critical Medicines Alliance (CMA), the EU Commission and EU Member States to better respond to potential supply shortages. Read more
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Pilot Results on Regulatory-Led RWE GenerationResults from a pilot on regulatory-led RWE generation (co-authored by the European Medicines Agency, EMA) have recently been published in the Clinical Pharmacology & Therapeutics journal. Read more
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Templates for Shortage Prevention and Mitigation Plans issued by EMAOn 18th of June 2024, the EMA has issued templates for Shortage Prevention Plans (SPPs) and Shortage Mitigation Plans (SMPs). Marketing authorization holders (MAHs) in the European Union/European Economic Area are encouraged to create Shortage Prevention Plans to minimize the risk of medicinal shortages. Read more
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New Measures to Report Medicine DisappearancesAccording to a press release from EDQM, Strasbourg, dated 04 July 2024, the Recommendation CM/Rec(2024)3 of the Committee of Ministers to member States on reporting of disappearances of medicinal products for human and veterinary use from the legal supply chain was adopted by the Council of Europe Committee of Ministers on 10 April 2024. Read more
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EMA: Q&A document for "Centralised Procedures" updated againIn June 2024 the Q&A documents relating to centralised marketing authorization procedures were updated again and published on the website of the European Medicines Agency (EMA). These Q&A catalogues are intended to provide assistance and guidelines for Marketing Authorization Holders and applicants for centralised procedures and provide answers to possible questions at different stages of the centralised marketing authorization application. Read more
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New Ph. Eur. Chapter on Elemental Impurities in Plastic MaterialsThe general Ph. Eur. chapter 5.20 Elemental impurities includes parts of the introduction and scope of the ICH Q3D guideline (Guideline for Elemental Impurities). As general chapter 5.20 is referenced in the general Ph. Eur. monograph Pharmaceutical preparations, its requirements are legally binding. These requirements cover extractable elements originating from plastic containers and closures for pharmaceutical use. Read more
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Council of Europe adopts recommendation on reporting of disappearances of medicinesIn the past decade, Europe has seen a number of major pan-European cases where medicines have disappeared from the legal supply chain, and then been manipulated or tampered with before being reintroduced into it. This clearly presents a risk for public health. Read more
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First nasal adrenaline spray for emergency treatment against allergic reactionsEMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Eurneffy (epinephrine), the first medicine to be taken through the nose for the emergency treatment of allergic reactions (anaphylaxis). Read more
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Requirements for Sterile Packaging MaterialThe European Directorate for the Quality of Medicines & HealthCare (EDQM) has drafted a guideline on "Content of the dossier for sterile substances". The document is available for public consultation until 15 August 2024. After the consultation phase the final guideline will be made available on the EDQM website. Read more
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ICH Q3C: New Version of the Guideline for Residual Solvents publishedSince the end of April 2024, the ninth revision of the "IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS Q3C(R9)" of the ICH (INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE) has been available on the ICH website under the heading "Quality Guidelines". This version includes revisions and adjustments in section 3.4 Analytical Procedures. Read more
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EMA: Update of the Annex to the Excipients GuidelineIn April 2024, the fourth revision of the Annex to the Guideline "Excipients in the labeling and package leaflet of medicinal products for human use" was published on the EMA website. Read more
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European Pharmaceutical Review Article on ICH Q2(R2)In the European Pharmaceutical Review, a new article entitled "Advancements and knowledge gaps in ICH Q2(R2)" was published. Read more
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ICH Q3C: New Version of the Guideline for Residual Solvents publishedSince the end of April 2024, the ninth revision of the "IMPURITIES: GUIDELINE FOR RESIDUAL SOLVENTS Q3C(R9)" of the ICH (INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE) has been available on the ICH website under the heading "Quality Guidelines". This version includes revisions and adjustments in section 3.4 Analytical Procedures. Read more
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Recommendations from EMA to strengthen supply chains of critical medicines publishedOn 23rd of April 2024 the EMA (European Medicines Agency) has published a list of recommendations to strengthen supply chains of products listed in the Union list of critical medicines. Read more
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EMA: Update of the Q&A Documents on the Topic of "Centralised Procedures"In March 2024, the "Questions & Answers (Q&A)" documents relating to centralised procedures were again updated and published on the website of the European Medicines Agency (EMA). These Q&A catalogues are intended to provide assistance and guidelines for marketing authorisation holders and applicants for centralised procedures and provide answers to possible questions at different stages of the centralised marketing authorisation application. Read more
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Lean GMP: is "right-sizing" GMP and Compliance possible?Good Manufacturing Practices (GMP) in the pharmaceutical industry are designed to ensure that products are consistently produced and controlled according to defined quality standards. However, it's common for companies to overinterpret regulations, leading to unnecessary processes that can inflate costs and reduce efficiency. Read more
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EMA: Update of the Q&A Documents on the Topic of "Centralised Procedures"In March 2024, the "Questions & Answers (Q&A)" documents relating to centralised procedures were again updated and published on the website of the European Medicines Agency (EMA). These Q&A catalogues are intended to provide assistance and guidelines for marketing authorisation holders and applicants for centralised procedures and provide answers to possible questions at different stages of the centralised marketing authorisation application. Read more
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APIC: Best Practices Guide for dealing with SuppliersThe "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety. The previous document has been completely revised, although the original annexes have been retained and an additional Annex 2 entitled "Commitment declaration (template)" has been added. Read more
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New recommendations to strengthen supply chains of critical medicinesEMA has published a number of recommendations to address vulnerabilities in the production and delivery of medicines included in the Union list of critical medicines and strengthen their supply chain. Read more
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Unexpected Deviations: the Role of the QPAnnex 16 to the EU-GMP Guidelines (Certification by a Qualified Person and Batch Release) states in section 3 that "provided registered specifications (…) are met, a QP may consider confirming compliance or certifying a batch where an unexpected deviation concerning the manufacturing process and/or the analytical control methods from details contained within the MA and/or GMP has occurred". Read more
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Critical medicine shortages - immediate workflow and trial phase with two ongoing shortagesThe task of the European Drug Shortages Formulary Working Party (EDSForm WP), created at the end of November 2023, is to define both short-term and long-term actions aimed at mitigating the negative impact of medicine shortages on public health. Read more
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European Pharmacopoeia to put an end to all animal tests for histamine and depressor substancesAt its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) decided to engage on a path that should ultimately lead to the deletion of the general chapters on Histamine (2.6.10) and Depressor substances (2.6.11) from the European Pharmacopoeia (Ph. Eur.). Read more
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APIC: Best Practices Guide for dealing with SuppliersThe "Best practices guide for managing suppliers of API manufacturers" was finalised by the "APIC Supplier Management Task Force" in March 2024 and is now available on the APIC website. It emerged from the document "Supplier Qualification and Management Guideline", which was first published in 2009, and now replaces it in its entirety. The previous document has been completely revised, although the original annexes have been retained and an additional Annex 2 entitled "Commitment declaration (template)" has been added. Read more
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Pharmeuropa 36.2 just releasedAll new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 36.2 is 30 June 2024. Read more
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EDQM: Updated Information on the Quality Overall Summary (Module 2)The revision 1 of the document "Quality overall summary (QOS) template for CEP applications", which was updated in January, has been published on the EDQM website. It is intended to provide assistance for CEP applicants and was first published in 2015. It lists the individual points of the QOS of Module 2 in detail and describes their required content. Read more
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How CEP holders can avoid the rejection of notificationsIn order to facilitate the acceptance of proposed changes in a timely manner, CEP holders are reminded that the European Directorate for the Quality of Medicines & HealthCare (EDQM) Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs (PA/PH/CEP (04) 2, 7R corr) lists different notifications and associated conditions, and that any change not classified as a notification or a major change should be classified as a minor change by default (with the exception of editorial changes for which specific guidance is given in the policy document). If the change cannot be classified by the document and specifically as a notification, a minor revision (by default) should be submitted. Any submission of a notification which includes changes not classifiable as a notification will be rejected and the changes will then need to be resubmitted using the correct classification (with associated documentation and fee). Read more
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APIC Quality Agreement Guideline: Update publishedThe first version of the document "Quality Agreement Guideline & Template" was published in 2009, updated in 2017 and has now been revised again. Version 3 of the guideline was published in January 2024 and is now available on the APIC (Active Pharmaceutical Ingredient Committee) website in the "Publications" tab. Read more
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EMA/CMDh: Appendix 1 for Nitrosamines Updated AgainThe nitrosamine Q&A document "Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" of the EMA/CMDh contains three appendices (Appendix 1-3) in its current version of October 2023. These documents are published on the EMA website and can be viewed under "Questions and answers". Read more
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EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy ApplicationsThe FDA and the European Medicines Agency (EMA) published "EMA–FDA joint Q&As on Quality and GMP aspects" supporting quality development for FDA’s Breakthrough Therapy (BT) and EMA's Priority Medicines (PRIME) programs. Read more
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EDQM: Top Ten Deficiencies for CEPsIn February 2024, the EDQM (European Directorate for the Quality of Medicines & HealthCare) has published its summary of the top ten deficiencies which occurred during the evaluations of the CEPs in 2023. This document called "TOP TEN DEFICIENCIES in New Applications for Certificates of Suitability for chemical purity" should help applicants to avoid such deficiencies in future and lists in detail the findings and its respective sections. In addition, it is recommended to use the EDQM guideline "Content of the dossier for chemical purity and microbiological quality", which was implemented in January 2019, for compiling the CEP dossiers. Read more
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Improving Registration and Reporting Summary Results Information for Clinical TrialsThe FDA is announcing a newly published report on the Clinical Trials Transformation Initiative (CTTI) prepared on the findings of a collaborative project with FDA to understand the barriers to timely, accurate and complete registration and reporting of summary results information for applicable clinical trials. According to the report, the major challenge was a lack of understanding on the part of the Responsible Party regarding the types of trials that must be registered, when the trial should be registered, and when and for which trials summary results information must be submitted. Read more
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EMA/CHMP/CVMP: New Q&A document for the Use of CEPsIn the middle of February, the document "QWP Questions and Answers (Q&A): how to use a CEP in the context of a Marketing Authorization Application (MAA) or a Marketing Authorization Variation (MAV)" prepared by the EMA, the CHMP (Committee for Medicinal Products for Human Use) and the CVMP (Committee for Medicinal Products for Veterinary use) was published on the EMA website for the first time. The Q&As should be seen as an orientation for marketing authorization holders and applicants when submitting applications and variation notifications. They explain the use of CEPs in this regard. Excipients that are described by a CEP and are used as an API are also mentioned here. Read more
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Continued efforts needed to fight antimicrobial resistance (AMR) in humans and animalsResistance of Salmonella and Campylobacter bacteria to commonly used antimicrobials continues to be observed frequently in humans and animals, according to a report issued today by the European Food Safety Authority (EFSA) and the European Centre for Disease Prevention and Control (ECDC). Read more
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The ICH E2D(R1) draft Guideline presentation available now on the ICH websiteThe ICH E2D(R1) draft Guideline on “Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports (ICSRs)” reached Step 2b of the ICH Process in February 2024 and entered the consultation period. A Step 2 Informational Presentation has also been developed by the Expert Working Group and is now available for download on the E2D(R1) page. Read more
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Checklist for Implementation of GDP Principles - Part 4: DocumentationChapter 4 (Documentation) of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01) points out that "good documentation constitutes an essential part of the quality system." Read more
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EDQM: Addendum 11.5 to the European Pharmacopoeia availableSupplement 11.5 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on 1 July 2024. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia - holder) are required to harmonise their specifications and thus the respective CEPs with the new monographs. Read more
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EMA/CMDh: Nitrosamine Q&A Document revisedThe EMA/CMDh nitrosamine Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" was updated again in January 2024 and is now available in revision 20. Like the three appenices, the Q&A document is published on the EMA website and can be viewed under "Questions and answers". Read more
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EMA publishes new questions and answers on Annex 1The European Medicines Agency (EMA) publishes answers to frequently asked questions on good manufacturing practice (CGMP) and good distribution practice (GDP) on its website at irregular intervals, as discussed and agreed by the GMP/GDP inspectors' working group. The published questions and answers may also become obsolete and then be removed when the relevant guidelines are updated. Read more
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Falsified Medicines in the Legal Supply ChainFalsified medicines do not meet the standards of safety, efficacy and quality as are required and may pose a serious risk to public and animal health. That is why the topic is explicitly addressed in the EU GDP guidelines. Read more
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New strategy for N-nitrosamine impurities in Ph. Eur. monographsAt its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) approved the strategy for N-nitrosamine impurities in individual monographs. Read more
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EDQM clarifies its policy for confidentiality and declassification of CEP documentsEDQM has elaborated a document describing the principles for the declassification of documents pertaining to the CEP procedure while ensuring when necessary, the confidentiality of information. Read more
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Update of the EMA Q&A document on Combination ProductsCombination products (the combination of a medicinal product and a medical device) are increasingly "on the rise". However, the regulation governing these combination products is very complex. On the one hand, the pharmaceutical legal requirements regarding marketing authorization and GMP must be complied with. Inspections are then carried out by GMP supervision authorities. On the other hand, the legal requirements for medical devices must also be taken into account. This means orientation towards the Medical Device Regulation (MDR) and compliance with harmonized standards. A notified body may also be involved. Things are different in the USA, where there exist specific GMP regulations for combination products. For the EU area, assistance is provided in the EMA Q&A document Questions & Answers for applicants, marketing authorization holders of medicinal products and notified bodies with respect to the implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746). Read more
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EMA/CMDh: Update Q&A Document for NitrosaminesThe current version of the EMA/CMDh nitrosamine Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products", dated October 2023, contains Annex 1 and three further appendices (Appendix 1-3). These documents are published on the EMA website and can be viewed under "Questions and Answers". Read more
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ICH Guidelines Q2(R2) "Validation of Analytical Procedures" and ICH Q14 "Analytical Procedure Development" publishedAs already reported, the Assembly of the International Council for Harmonisation (ICH) met in person on 31 October and 01 November 2023 in Prague, Czech Republic. During this meeting, the ICH Q2(R2) Revised Guideline on "Validation of Analytical Procedures” and the new ICH Q14 Guideline on “Analytical Procedure Development” were adopted by the ICH Assembly Regulatory Members. Read more
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Retirada do PVP nas embalagens dos medicamentos | Decreto Lei 128/2023, de 26 de dezembroCom a publicação do Decreto-Lei n.º 128/2023, de 26 de dezembro publicado no Diário da República, 1ª Série, n.º 247, de 26 de dezembro, o qual veio alterar o regime jurídico dos medicamentos de uso humano e das farmácias de oficina, nomeadamente quanto à obrigatoriedade da menção do preço de venda ao público (PVP) na rotulagem do acondicionamento secundário e, caso não exista, do acondicionamento primário do medicamento. Read more
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Pharmeuropa 36.1 just releasedAll new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 36.1 is 31 March 2024. Read more
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Nitrosaminas em medicamentos de uso humanoEm 2019 foi iniciada a avaliação do risco de presença de nitrosaminas nos medicamentos devendo ser testados todos os medicamentos com potencial risco, reportando os resultados às autoridades competentes. Read more
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Publicado relatório intercalar da Estratégia da Rede Europeia de Agências de Medicamentos 2020-2025A Agência Europeia de Medicamentos (EMA na sigla em inglês) e os Chefes das Agências de Medicamentos (HMA na sigla em inglês) apresentam resultados intermédios da Estratégia 2025: o relatório intercalar da Estratégia da Rede Europeia de Agências de Medicamentos 2020-2025 (EMANS) foi publicado hoje e pode ser consultado no site da EMA. Read more
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EDQM welcomes EU Parliament and Council’s political agreement on enhanced safety and quality for substances of human originThe European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe welcomes the recent provisional agreement reached between the European Parliament and the Council of the European Union (EU) on the draft regulation on blood, tissues and cells. This marks a pivotal step towards harmonising quality and safety standards for substances of human origin (SoHO) across the EU. This provisional agreement will now have to be endorsed by the Council and the Parliament. Read more
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CTR / CTIS Guidance UpdateThe EMA and the HMA published the following revised guidance documents relating to the CTIS transparency rules and the transition of clinical trials. Read more
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EDQM: Updates on CEP DossiersWith regard to the "CEP 2.0", the EDQM (European Directorate for the Quality of Medicines & HealthCare) has once again provided information on the "EMA SPOR/OMS ORG_IDs" and "LOC_IDs" ("unique identifiers for an organisation" / "unique identifiers for its locations") on their website. Read more
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Reports confirm the European Health Union is better prepared to combat health threats
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EU and MHRA extend GMP and GDP CertificatesThe validity of EU GMP and GDP certificates is to remain in place until 2024 or until the completion of the next on-site inspection, whichever comes first. Until then, supervision will be performed risk-based. Read more
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GDP-compliant Storage of APIs: What needs to be considered?Medicinal products are subject to special regulations for storage and transport. Good Distribution Practice (GDP) is the part of quality assurance that ensures that the quality of medicinal products is maintained at all stages of the supply chain. Read more
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First Electronic Product Information (ePI) for Human MedicinesThe EMA recently announced that the Heads of Medicines Agencies (HMA), the European Commission (EC) and the EMA have published for the first time electronic product information (ePI) for selected human medicines harmonized across the European Union (EU). Read more
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EMA launches Website for accelerating EU Clinical TrialsThe EMA has launched a dedicated website for the Accelerating clinical trials in the European Union (ACT EU) initiative, co-led by the European Commission, the Heads of Medicines Agencies and the European Medicines Agency (EMA). The website contains updates on the progress of ACT EU priority actions, which aim to improve the clinical trials environment in the EU through harmonization, innovation, and stakeholder collaboration. Read more
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News on CEP 2.0: SpecificationsOnce again, the EDQM (European Directorate for the Quality of Medicines & HealthCare) has published further information on its website with regard to the "CEP 2.0". The presentation and content of section 3.2.S.4.1 Specification are now discussed and explained. Read more
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EDQM launches updated version of the EuroGTP II tool to ensure good tissue and cell practices for human applicationTo help ensure quality and safety in the field of substances of human origin (SoHO), the European Directorate for the Quality of Medicines & HealthCare (EDQM) has been entrusted with managing the EuroGTP II tool for good tissue and cell practices. Starting on 15 November 2023, this interactive assessment tool will be hosted on the EDQM SoHO platform, along with the Microbiological Risk of Contamination Assessment (MiRCA) tool. Read more
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EDQM: Supplement 11.4 to the European Pharmacopoeia availableThe supplement 11.4 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on the 1st of April 2024. According to the EDQM timetable, this supplement will be followed by versions 11.5 to 11.8, with the final implementation date planned for July 2025. The 12th edition of the European Pharmacopoeia (Ph.Eur.) will then be published in July 2025 and enter into force in January 2026. The schedule for the implementation and publication of the individual versions and supplements can be found on the EDQM website. Read more
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First electronic product information (ePI) published for selected human medicinesThe Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA have published for the first time electronic product information (ePI) for selected human medicines harmonised across the European Union (EU). Read more
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EMA publishes "Toolkit" for Shortages of Medicinal ProductsThe European Medicines Agency EMA has published a so called "MSSG Toolkit on recommendations on tackling shortages of medicinal products", a guidance document for use by the MSSG to facilitate identification of recommendations on critical shortages of medicinal products. Read more
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EMA encourages companies to submit type I variations for 2023 in November 2023EMA is advising marketing authorisation holders to submit type IA and type IAIN variations for 2023 no later than Thursday, 30 November 2023. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 25 December 2023 and 3 January 2024 and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008. Read more
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EMA revises Guidance on Development, Production, Characterization and Specification for Monoclonal Antibodies and related Products.In July, the EMA announced the 2nd revision of its guidance document on "Quality of Monoclonal Antibodies and Related Products". Read more
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EU Commission: Strategy Paper with Measures against Medicine Supply ShortagesThe European Commission has adopted a package of measures to prevent and mitigate shortages of critical medicines in the EU this coming winter, next winter and beyond. The reform of the pharmaceutical legislation, announced in April 2023, includes a package of measures aimed at increasing long-term security of supply or managing medicine shortages. The "set of actions" now presented complements the reform of the pharmaceutical law. Read more
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Comissão Europeia propõe várias medidas para a prevenção da escassez de medicamentos na EuropaA Comissão Europeia acaba de publicar a Comunicação “Commission steps up actions to address critical shortages of medicines and strengthen security of supply in the EU” que propõe várias medidas para reforçar a prevenção da escassez de medicamentos na Europa, no curto, médio e longo prazo. Entre as propostas apresentadas, incluem-se medidas de monitorização, troca de informação e prevenção da escassez, que já vêm sendo trabalhadas pelas autoridades nacionais, em conjunto com a EMA, e que poderão ser reforçadas no âmbito desta estratégia agora divulgada. Read more
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EMA Publishes revised CTIS Transparency RulesFollowing the public consultation on the revision of the transparency rules for the Clinical Trials Information System (CTIS), the European Medicines Agency (EMA) has now endorsed the revised transparency rules. According to the agency, the simplifications introduced will give access to clinical trial information to stakeholders, patients and healthcare professionals in a faster and more efficient way. Read more
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EMA takes further steps to address critical shortages of medicines in the EUEMA published PDF icon details of the newly created solidarity mechanism developed by the EMA Medicines Shortages Steering Group (MSSG). This voluntary mechanism allows Member States to support each other in the face of a critical medicine shortage. Read more
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GDP-compliant Transport of APIs: What needs to be considered?Medicinal products are subject to special regulations for storage and transport. Good Distribution Practice (GDP) is the part of quality assurance that ensures that the quality of medicinal products is maintained at all stages of the supply chain. Read more
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Why does the FDA inspect in EU despite the MRA?The main objective of the MRA (Mutual Recognition Agreement) between the EU and the FDA established in 2019 was to mutually recognise GMP inspection systems and reduce the number of inspections. However, this does not mean that there are no more mutual inspections at all. This is not only due to the exceptions laid down in the original document (human blood, human plasma, human tissue and organs, and immunological veterinary medicinal products), but also because of a certain degree of discretion. For example, Chapter 3 (Operational Aspects), Article 8 (Acceptance of Inspections), paragraph 2, states: "A Party may in specific circumstances opt not to accept an official GMPs document issued by a recognized authority of the other Party for manufacturing facilities located in the territory of the issuing authority." Read more
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EDQM joins efforts to tackle medicine shortagesMedicine shortages are a growing problem that compromises patient care. Two key committees at the European Directorate for the Quality of Medicines & HealthCare (EDQM), the European Committee on Pharmaceuticals and Pharmaceutical Care (CD-P-PH) and the European Pharmacopoeia Commission (EPC), are working together to alleviate shortages through the use of unlicensed pharmaceutical preparations prepared in pharmacies. These have already proven to be an effective tool during specific medicine shortages in some countries. Read more
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What is "Root Cause Analysis (RCA)"?Root Cause Analysis (RCA) is an important part in CAPA processes in the pharmaceutical industry. RCA is a structured approach to the investigation process that aims to determine the underlying cause of a detected nonconformity or other undesirable situation. By identifying and eliminating the root cause, CAPA processes can prevent the recurrence or occurrence of quality problems and improve product and process performance. Read more
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EMA publica revisão das regras de transparência de informações sobre ensaios clínicosA Agência Europeia de Medicamentos (EMA) publicou uma revisão das regras de transparência da publicação de informações sobre ensaios clínicos, apresentadas através do Sistema de Informação sobre Ensaios Clínicos (CTIS). As simplificações introduzidas darão acesso às informações dos ensaios clínicos às partes interessadas, incluindo os cidadãos, pessoas com doença e os profissionais de saúde, de uma forma mais rápida e eficiente. Read more
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EMA: Updates in the Product Lifecycle Management (PLM) PortalNew and revised guidance documents and materials relating to ePI (electronic Product Information) are now available on the EMA website under the heading "What's New in PLM?" in the PLM Portal (Product Lifecycle Management Portal). Read more
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Pharmeuropa 35.4 just releasedAll new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 35.4 is 31 December 2023. Read more
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EDQM: CEP 2.0 implementedSince the beginning of September 2023, the CEP 2.0 is implemented by the EDQM (European Directorate for the Quality of Medicines & HealthCare). From now on, applicants of a new dossier or renewals will receive a CEP 2.0. This will be available as a PDF file in the so called sharing tool "DCEP" and will be signed electronically only. The document "Certificates of suitability: electronic signature features", which is available on the website of the EDQM, explains how the electronic signatures are used and how you can detect valid and invalid electronic signatures. For any cases, the CEP holder has doubts regarding the electronic signatures, the EDQM helpdesk may be contacted. Read more
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CEP 2.0 – Certificates of suitability: electronic signature featuresOn 1 September 2023, the European Directorate for the Quality of Medicines & HealthCare (EDQM) implemented electronic signatures for CEPs and some other documents as part of the CEP 2.0 project. A document explaining the features of electronic signatures is now available on our website: Certificates of suitability: electronic signature features. Read more
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Electronic Submission Portal for CosmeticsThe U.S. FDA is seeking comments on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). According to the agency, Cosmetics Direct includes the required registration and listing submission information from the paper forms in a standard electronic format. This will help the applicant organize their registration and listing submission to include the information needed for FDA and will give access to the previous Cosmetic Direct registrations and listing submissions. Read more
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WHO issues draft Guidance on Best Practices for Clinical TrialsThe World Health Organization (WHO) published a draft guideline on best practices for clinical trials. The deadline for comments is 15 September 2023. Read more
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Validating analytical procedures for determining nitrosamines in pharmaceuticals: European OMCLs participate in collaborative study with international regulatory agenciesThe European Directorate for the Quality of Medicines & HealthCare (EDQM) and representatives of official medicines control laboratories (OMCLs) in Europe, as well as the US Food and Drug Administration, Health Canada and the Therapeutic Goods Administration, Australia, have co-authored an article entitled “Performance Characteristics of Mass Spectrometry-Based Analytical Procedures for Quantitation of Nitrosamines in Pharmaceuticals: Insights from an Inter-laboratory Study”, published in the Journal of Pharmaceutical Sciences in July 2023. Read more
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Publication of EMA Document on the Establishment of a Guideline on mRNA VaccinesThe published document from the European Medicines Agency addresses the need to establish a guideline on the quality aspects of mRNA vaccines. In recent years, the number of applications for clinical trials for human medicinal products as well as for marketing authorization for mRNA-containing medicinal products has increased significantly and is expected to continue to increase in the near future. From an analytical and regulatory perspective, mRNA vaccines are of interest because their classification depends on the target and/or whether they are derived by chemical or biological means. mRNA vaccines against infectious diseases must comply with the current guidelines for human vaccines. However, this new technology is not fully addressed in the existing documents. It is therefore proposed that a guideline be developed to address the specific aspects of the manufacturing process, characterization, specifications, and analytical control, as well as the definition of the active ingredient and finished product for mRNA vaccines for the prevention of infectious diseases. Read more
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EMA dá parecer positivo a vacina adaptada para COVID-19As vacinas para COVID-19 adaptadas à variante Ómicron XBB.1.5, a usar na campanha de vacinação sazonal contra gripe e COVID-19 2023/2024 obtiveram parecer favorável do Comité dos Medicamentos de Uso Humano da Agência Europeia de Medicamentos (EMA), sendo aguardada a publicação de Autorização de Introdução no Mercado por parte da Comissão Europeia. Read more
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Renewed Revision of the Q&A Document on Nitrosamine Impurities: temporary acceptable intakes no longer need to be setOnly three weeks after the publication of Revision 16 of the EMA/CMDh question and answer document on nitrosamine impurities in medicinal products for human use, the newly revised version of this document (Rev. 17) was issued on the EMA's "Nitrosamine Impurities" website. The reason for the further update is the now obsolete requirement to define temporary acceptable intakes (t-AI) for nitrosamines with the introduction of the Carcinogenic Potency Categorization Approach (CPCA) (also see our news The New Annex to EMA's Question and Answer Document on the Determination of Acceptable Intake Levels of Nitrosamines). The answer to question 21 ("What is the approach to control the presence of nitrosamines until a substance specific AI is established?") has been adapted accordingly (meaning: With the application of the CPCA and the extended AMES test, the establishment of a temporary AI [t-AI] is no longer necessary) and the part of the sentence regarding the t-AI in question 20 ("What are the regulatory steps taken by authorities following the identification of an N-nitrosamine exceeding the AI?") has been deleted. Read more
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The possible Impact of Artificial Intelligence on the Role of the Qualified PersonArtificial intelligence (AI) is revolutionising industry and the pharmaceutical sector is no exception. AI is impacting various aspects of drug discovery, development, manufacturing, and patient care. At present, AI is beginning to be used primarily in drug discovery and development. For example, AI can accelerate the process of virtual screening, reducing the time and cost associated with traditional drug discovery methods. Furthermore, AI algorithms can analyse vast amounts of biomedical data, including genomic data, scientific literature, and non-clinical and clinical trial results, to identify potential drug targets and predict drug efficacy. In assisting in reviewing documentation and identifying gaps or non-compliance issues AI can streamline regulatory submission process and ensure adherence to complex regulatory requirements. Read more
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New EMA Reflection Paper on the use of Artificial IntelligenceOn 19 July 2023, the EMA (European Medicines Agency) published a Reflection Paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle. This document is open for comments until 31. December 2023. What is the content of the document? Read more
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CMDh/HMA: Best Practice Guide on VariationsIn July 2023, individual chapters of the "Best Practice Guides (BPGs) for the Submission and Processing of Variations in the Mutual Recognition Procedure" were updated and published on the HMA (Heads of Medicines Agencies) website. Read more
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Can Productivity Applications be Used in Clinical Trials?EMA's GCP Inspectors Working Group added a new Question & Answer relating to Productivity Applications in the section "GCP matters" of the Good Clinical Practice (GCP) Q&As. What are the Expectations for Productivity Applications used in Clinical Trials? Read more
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Medicamentos contendo valproato: revisão pela EMA dos dados sobre a exposição paternaO Comité de Avaliação do Risco em Farmacovigilância (PRAC), da Agência Europeia de Medicamentos (EMA na sigla em inglês), está a analisar dados sobre o risco potencial de perturbações do neurodesenvolvimento (PND) em crianças concebidas por homens a tomar medicamentos contendo valproato. Read more
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EDQM: Supplement 11.3 to the European Pharmacopoeia availableSupplement 11.3 to the European Pharmacopoeia (Ph.Eur.) is now available and will be implemented on 1 January 2024. According to the EDQM timetable, this supplement will be followed by versions 11.4 to 11.8, with the final implementation date planned for July 2025. Read more
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FDA´s draft Guidance on Postmarketing NoncomplianceThe FDA may require certain postmarketing studies and clinical trials for prescription drugs at the time of approval or after approval if the agency becomes aware of new safety information. Read more
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Adjusting for Covariates in Randomized Clinical TrialsThe FDA has issued a new guidance together with a Guidance Snapshot which describes the agency's current thinking regarding adjusting for covariates in the statistical analysis of randomized clinical trials. Sponsors should adjust for baseline covariates that are strongly associated with an outcome in a clinical trial population. According to the agency, the new guidance is consistent with the ICH guidance E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and Sensitivity Analysis in Clinical Trials. Read more
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Remote Access to Study Data in Clinical Trials - What needs to be consideredEMA's GCP Inspectors Working Group added a new Question & Answer No. 3 relating to direct remote access in the section on "Records of Study Subject Data Related to Clinical Trials" of the Good Clinical Practice (GCP) Q&As. Read more
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New EMA Reflection Paper on the use of Artificial IntelligenceThe topic of artificial intelligence (AI) has been gaining more and more importance recently. The success of ChatGPT and the corresponding reporting have made the topic accessible to a broad public. Read more
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ICH Update on GCP related Topics including RWD/RWEFollowing the recently published Draft ICH E6(R3) Guideline on Good Clinical Practice (GCP) the ICH announced the following progress on several new ICH Efficacy Guidelines. Read more
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Important update on N-nitrosamine impurities in substances covered by CEPsOn 7 July 2023, the EMA published a revised version of the “Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products”. Read more
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Reflection paper on the use of artificial intelligence in the lifecycle of medicinesEMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper, which is now open for public consultation, reflects on principles relevant to the application of AI and machine learning (ML) at any step of a medicines’ lifecycle, from drug discovery to the post-authorisation setting. Read more
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European Health Union: EU steps up action to prevent shortages of antibiotics for next winterThe European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency are today issuing recommendations for actions to avoid shortages of key antibiotics used to treat respiratory infections for European patients in the next winter season. These recommendations, which have been developed through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), complement the process to develop an EU list of critical medicines. In close cooperation with the EU Member States, the Commission will take operational follow-up actions, including, if necessary, possible joint procurements. Read more
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Projeto Piloto eFI (folheto informativo em formato eletrónico): 1ª fase medicamentos de uso exclusivo hospitalarO INFARMED, I.P. pretende iniciar o projeto piloto eFI (Folheto Informativo em formato eletrónico), que consiste na retirada dos folhetos informativos em papel das embalagens de medicamentos destinadas a ser comercializadas apenas no circuito hospitalar e para utilização no próprio hospital, ficando assim excluídos os medicamentos destinados a dispensa em ambulatório hospitalar, neste momento. Esta iniciativa conta com o envolvimento da APFH (Associação Portuguesa de Farmacêuticos Hospitalares), da APIFARMA (Associação Portuguesa da Indústria Farmacêutica) e da APOGEN (Associação Portuguesa de Medicamentos Genéricos e Biossimilares). Read more
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Ph. Eur. Update on Pharmaceutical PreparationsA revised version of the Ph. Eur. general monograph Pharmaceutical Preparations has been published in Pharmeuropa 35.3. The comment deadline is 30 September 2023. Read more
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EMA starts Review of Transparency Rules for the CTISThe European Medicines Agency (EMA) had launched a public consultation on the revision of the transparency rules of the Clinical Trials Information System (CTIS). Stakeholders were invited to send their comments via an online form by end of June 2023. According to the Agency, the consultation intended to collect views from system users and stakeholders and stimulate discussions on the best possible approaches to balance transparency of clinical trials data in CTIS with confidentiality requirements, while also simplifying the modalities of use of the new system. Read more
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Quality Culture in the Pharmaceutical Industry: Benefits and ChallengesThe pharmaceutical industry plays a vital role in public health, as it is responsible for developing and manufacturing life-saving medicines. In this critical sector, ensuring product quality and patient safety are paramount. To achieve these objectives, the industry is recognising the significance of cultivating a strong quality culture within organisations. Read more
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EMA publishes Comments on ICH M11 CeSHarPThe European Medicines Agency (EMA) published the ICH M11 (CeSHarP) draft Guideline for comments in October last year. ICH's new M11 Guideline is intended to provide a comprehensive clinical protocol organization with standardized content. Read more
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Dealing with Artificial Intelligence in the Context of the further Development of Software in Medical DevicesThe topic of artificial intelligence/machine learning (AI/ML) is currently all around. The FDA has also taken up this topic and published various draft guidance documents. A current draft is aimed at manufacturers of medical devices that contain software. Read more
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Potential Assays for Monoclonal Antibodies and Other Therapeutic ProteinsThe purpose of this guidance document is to provide recommendations in the development of monoclonal antibodies (mAbs) and other therapeutic proteins that directly target viral proteins or host cell proteins that mediate pathogenic mechanisms of infection. A critical quality control measure for these products is the development and implementation of potency assays to ensure that each batch is consistently manufactured with the potency required for clinical efficacy and that this potency is maintained throughout the shelf life of the product. Read more
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Use of real-world evidence in regulatory decision making – EMA publishes review of its studiesReal-world evidence (RWE) from studies led by regulators can complement evidence from other sources including clinical trials. RWE can support both pre-authorisation and post-approval assessments of EMA’s scientific committees, working parties and national competent authorities. However, more effort is needed to better anticipate the need for such studies and to speed up their initiation to ensure that regulators have access to RWE in a timely manner. Read more
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Infografia: Notificação de faltas pela farmáciaA notificação de faltas pelas farmácias é de extrema importância para a monitorização completa do mercado e para que o Infarmed desenvolva as medidas adequadas para evitar ou mitigar os constrangimentos que possam dificultar o acesso dos utentes aos medicamentos de que necessitam. Read more
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EMA starts Review of Transparency Rules for the CTISThe European Medicines Agency (EMA) has launched a public consultation on the revision of the transparency rules of the Clinical Trials Information System (CTIS). Stakeholders are invited to send their comments via an online form by 28 June 2023. According to the Agency, the consultation intends to collect views from system users and stakeholders and stimulate discussions on the best possible approaches to balance transparency of clinical trials data in CTIS with confidentiality requirements, while also simplifying the modalities of use of the new system. Read more
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ICH GCP Draft GuidelineFollowing the previously published ICH E6 draft principles the ICH E6(R3) Expert Working Group (EWG) has developed a revised Guideline on Good Clinical Practice (GCP). The ICH E6(R3) draft guideline is now available for public consultation. It intends to encourage the use of innovation and technologies that have the potential to make clinical trials more efficient. The deadline for EU comments is 26 September 2023. Read more
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The ICH E6(R3) draft Guideline presentation available now on the ICH websiteThe ICH E6(R3) draft Guideline on "Good Clinical Practice" reached Step 2b of the ICH Process in May 2023 and subsequently entered the consultation period. Read more
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EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variantsThe European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have issued a joint statement on adapted COVID-19 vaccines and considerations for their use during the upcoming autumn 2023 vaccination campaigns. Read more
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Boas práticas para a prevenção de ruturas de abastecimentoA rede HMA e EMA publicaram recomendações para a indústria contendo boas práticas para assegurar a continuidade do abastecimento de medicamentos, prevenir ruturas e reduzir o seu impacto na saúde dos doentes. Read more
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New EMA Guidance to prevent and mitigate Medicine ShortagesThe European Medicines Agency EMA has published a guidance for industry on "Good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact". Read more
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Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 2More than 60 participants attended the ECA Webinar "GDP Update 2023" on 16 March 2023. The aim of the two-hour event was to give a overview of current requirements and latest developments in GDP - those already realized and those planned. Read more
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Guidance for industry to prevent and mitigate medicine shortagesEMA has published recommendations for industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact. Read more
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New EMA Guidelines and Revisions in GMP AreaThe European Medicines Agency (EMA) has published a new version of the "3-year work plan for the Quality domain" for the period January 2021 - December 2023. The plan is being prepared by the GMP/GDP Inspectors Working Group (GMDP IWG) as part of the planned review after two years in March 2023. Read more
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EMA annual report 2022 publishedEMA published its annual report 2022 today. The report provides an overview of the Agency’s activities to protect and promote public and animal health in the European Union (EU). Read more
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Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effectsEMA’s safety committee, PRAC, is reminding healthcare professionals that the use of fluoroquinolone antibiotics, given by mouth, injection or inhalation, is restricted due to the risk of disabling, long-lasting and potentially irreversible side effects. Read more
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EMA updates Timelines of eAFs for Variations for Medicinal Products for Human UseIn future, submissions of variation notifications for medicinal products for human use are to be made exclusively via the electronic application forms (eAFs). The timelines for the full implementation of these systems have now been updated again and are listed on the EMA website in the PLM Portal (Product Lifecycle Management Portal). Read more
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Ph. Eur. Commission kicks off elaboration of three general texts on mRNA vaccines and componentsMessenger RNA (mRNA) vaccines have been at the forefront of vaccine development efforts during the COVID-19 pandemic. With two authorised mRNA-based vaccines on the market, the mRNA vaccine field continues to evolve, as this increasingly important technology can be tailored to fight different infectious diseases. More products currently in development are expected to reach the market in a relatively short time and multivalent vaccines may also soon follow. Read more
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GMP Update: Consequences from the New EU Commission ProposalOn 26 April 2023 the European Commission published the proposal for the envisaged revision of the EU pharmaceutical legislation. The changes are to be regulated in a directive and a regulation. Read more
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EDQM: Updates on CEP 2.0As part of the implementation of the new "CEP 2.0", the EDQM has now provided further information on its website. Read more
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Which Test Sets are used in the 100% Visual Inspection?In the 100% visual inspection of parenterals required by the pharmacopoeias, so-called test sets with different tasks and properties are used. Find out what these are and what needs to be taken into account. Read more
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Single-arm trials as pivotal evidence for the authorisation of medicines in the EU
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Pharmeuropa: Revised Chapter 2.9.1. "Disintegration of tablets and capsules" published for commentIn the Pharmeuropa issue 35.2, a proposal for a revised chapter 2.9.1 "Disintegration of tablets and capsules" was published. The deadline for submitting comments is 30 June 2023. Read more
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Alteração das instruções aos requerentes de pedidos de alteração, renovação e transferência de titular de AIMO INFARMED, I.P. procedeu a uma revisão das instruções aos requerentes de pedidos de alteração, renovação e transferência de titular e a alterações ao SMUH-ALTER, para a introdução de medidas de simplificação adotadas a nível europeu para as quais o Infarmed contribuiu ativamente, bem como para a introdução de medidas de simplificação de âmbito nacional. Read more
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Clinical Trials Regulation - Version 6.4 of the Q&AsThe European Commission (EC) published an updated Version 6.4 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). The Q&As entered into force together with the application of the CTR on 31 January 2022. Read more
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The ICH M7(R2) Guideline reaches Step 4 of the ICH ProcessThe ICH M7(R2) Guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and the accompanying M7(R2) Addendum “Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes” have reached Step 4 of the ICH Process on 3 April 2023. Read more
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ICH Information Material on the ICH Q9 revision Quality Risk ManagementSince 2005, the ICH Q9 Guideline on Quality Risk Management has represented the state of the art. A revision was announced at the end of 2020. In January, this revision has reached stage 4 and is now moving into implementation. Read more
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EU recommendations for 2023-2024 seasonal flu vaccine compositionEMA has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2023. Read more
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11th Edition of The International PharmacopoeiaThe International Pharmacopoeia (Ph. Int.) contains recommended procedures for analysis and specifications for pharmaceutical substances and dosage forms. According to the WHO (World Health Organization) it is intended to serve as source for reference or adaptation by any WHO Member State. The Ph. Int. is available online. It has legal status, whenever a national or regional authority refers to it in appropriate legislation. Read more
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ECHA reviews extended one-generation reproductive toxicity studies and recommends good practicesIn a review of 55 extended one-generation reproductive toxicity (EOGRT) studies, ECHA confirms their effectiveness in identifying substances of concern. Read more
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Advancing regulatory science in the EU – mid-point report publishedEMA has published a report summarising the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025. The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human and veterinary areas. Read more
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EDQM: New CEP 2.0The formerly named "CEP of the future" is now named "CEP 2.0", as recently reported on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare). The new design of the CEP shall support stakeholders in handling CEPs and shall increase the transparency of the provided information. Read more
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CEP 2.0: Use of EMA SPOR/OMS ORG_ID and LOC_ID mandatory for CEP applicationsAs part of the implementation of the CEP 2.0, it will be mandatory as of 1 June 2023 to provide, in the application forms for new dossiers, sister files and revisions and renewals, the EMA SPOR/OMS ORG_ID and LOC_ID for all companies involved in Certification of suitability (CEP) dossiers. Revised application forms for CEP submissions will be made available shortly. Read more
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Remote and online provision of medicines: EDQM targeted stakeholder consultationFrom 13 March to 26 May 2023, the European Directorate for the Quality of Medicines & HealthCare (EDQM) is undertaking a targeted consultation to seek the opinions of interested parties on a draft Council of Europe recommendation on best practices for the remote and online provision of medicines. The consultation targets international organisations active in public health and digital healthcare processes, competent authorities of member states, healthcare professionals, patients, the pharmaceutical industry and relevant associations. Read more
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HERA signs agreement with ECDC and with EMA to strengthen cooperation on health emergency preparedness and response
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Clinical Trials Regulation - Version 6.3 of the Q&AsThe European Commission (EC) published an updated Version 6.3 of the Questions & Answers (Q&As) relating to the EU Clinical Trials Regulation (CTR). The Q&As entered into force together with the application of the CTR on 31 January 2022. Read more
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EDQM: Supplement 11.2 of the European Pharmacopoeia availableSupplement 11.2 of the European Pharmacopoeia (Ph.Eur.) is now available. This supplemental edition lists several updated monographs that will be implemented on 01 July 2023. All CEP holders (Certificate of Suitability of Monographs of the European Pharmacopoeia holders) are encouraged to align their specifications and thus the respective CEPs to the new monographs. Read more
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Recommendations on Decentralized Elements in Clinical TrialsThe EU Commission has supplemented the area of clinical trials (see also corresponding guidelines for complex clinical trials) with "Recommendations on decentralized elements in clinical trials". The paper deals with procedures that, due to new approaches and advanced technical possibilities, can now take place outside study centers. The document also addresses sponsor and investigator roles and responsibilities, electronic informed consent, Investigational Medicinal Product (IMP) delivery, study-related home procedures, data management, and monitoring in a decentralized clinical trial (DCT) setting. Read more
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EDQM: Updated List of Reference SubstancesThe list of available reference standards is regularly updated on the website of the EDQM (European Directorate for the Quality of Medicines & HealthCare). It comprises more than 3,000 substances, including chemical reference substances, herbal reference standards and biological reference preparations as well as reference spectra for the performance of tests and trials according to Ph. Eur. methods. Read more
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EMA pilots scientific advice for certain high-risk medical devicesEMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices (all class III devices and class IIb active devices intended to administer and/or remove medicinal product(s)). As of today, manufacturers can submit their letter of interest to be part of the pilot on scientific advice which will be provided by the medical device expert panels. Read more
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Qualification of Customers - What needs to be considered?Wholesale distributors must verify that their customers are authorised to purchase medicinal products. Read more
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Consultation on Multi-Stakeholder Platform for improving EU Clinical TrialsThe EMA, together with the HMAs and the European Commission, is gradually implementing the priorities of its joint Accelerating Clinical Trials (ACT) initiative. Most recently, the European Commission published supplementary recommendations on "Decentralized Clinical Trials". Read more
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EU Survey on the Implementation of the Clinical Trial RegulationFrom January 31, 2023, the Clinical Trials Information System (CTIS) has become mandatory for EU clinical trial applications under the CTR (Clinical Trials Regulation). However, there are still some issues regarding the functionality of the CTIS. Now, the European Commission (EC), together with the EMA and the HMA, published the results of a consultation on the implementation of the CTR. This consultation took place from July to September 2022 and represents the views of the stakeholders at the time of the consultation. The report notes that there is still a lack of harmonization at the level of national legislation and accompanying procedures in the Member States (MS). However, as the CTR leaves it to the member states to regulate individual details for implementation in many cases, it should come as no surprise that there are different interpretations and implementations of the CTR requirements in Europe. Read more
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The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed AnalysisEarlier in February you could read about the publication of the revised ICH Q9 guideline. What are the new features of Quality Risk Management (QRM)? Read more
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Public Consultation on two Ph. Eur. Chapters on Pharmaceutical Technology ProceduresThe European Directorate for the Quality of Medicines & HealthCare (EDQM) indicated in a press release dated 01 February 2023 that the public consultation on two Ph. Eur. chapters on pharmaceutical technology procedures has been started. These are the revised general chapter 2.9.3 "Dissolution of tablets and capsules" and the new chapter 2.9.55 "Characterisation of powder behaviour during compression". Both texts were recently published in Pharmeuropa 35.1. Read more
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PRAC starts safety review of pseudoephedrine-containing medicinesEMA’s safety committee (PRAC) has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS), conditions affecting blood vessels in the brain. Pseudoephedrine is taken by mouth and is used alone or in combination with other medicines to treat nasal congestion (a blocked nose) resulting from a cold, flu or allergy. Read more
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CEPs: EDQM establishes New ProcedureBy the end of 2022, the EDQM (European Directorate for the Quality of Medicines & HealthCare) has adopted the document "Management of CEP guidelines and operational documents for the CEP procedure" and published it on its website. This document explains the new process for the development of supporting documentation related to CEPs (Certificate of Suitability of Monographs of the European Pharmacopoeia). Read more
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Actions to support the development of medicines for childrenRegulators in the European Union (EU) have taken several initiatives in the past four years to increase the efficiency of paediatric regulatory processes and boost the development of medicines for children. These achievements are highlighted in the PDF icon closing report of the EMA and European Commission (EC) action plan on paediatrics. Read more
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Public consultation on a multi-stakeholder platform to improve clinical trials in the EUOn 3 February 2023, EMA, the Heads of Medicines Agencies (HMA) and the European Commission (EC) are launching a public consultation on the establishment of a multi-stakeholder platform to improve clinical trials in the European Union (EU). The multi-stakeholder platform is a deliverable of the joint initiative Accelerating Clinical Trials in the EU (ACT EU). Read more
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Updated ICH E2B(R3) Q&As on ICRsOn 17 January 2023, the updated ICH E2B(R3) Questions & Answers (Q&As) Version 2.4 for the ICH E2B(R3) Guideline: Electronic Transmission of Individual Case Safety Reports (ICSRs) has reached Step 4 of the ICH Process. Read more
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Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EUFrom 31 January 2023, all initial clinical trial applications in the European Union (EU) must be submitted via the Clinical Trials Information System (CTIS). CTIS is now the single-entry point for sponsors and regulators of clinical trials for the submission and assessment of clinical trial data. This follows a one-year transition, during which sponsors could choose whether to apply for a new clinical trial in the EU/EEA in line with the Clinical Trials Directive or under the new Clinical Trials Regulation (CTR), which entered into application on 31 January 2022. Read more
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CEP holders – How to submit a nitrosamine risk assessmentTo facilitate the acceptance of proposed changes in a timely manner, the European Directorate for the Quality of Medicines & HealthCare (EDQM) would like to draw the attention of CEP holders to the following details regard minor revisions. Read more
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EMA update on shortages of antibiotics in the EUEMA's Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) met on Thursday to discuss the progress made and to agree on the next steps in the coordinated response to the ongoing shortages of antibiotic medicines containing amoxicillin (alone and in combination with clavulanic acid) in the EU. The MSSG is made up of representatives from EMA, the European Commission and the Heads of Medicines Agencies (HMA). Read more
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Update of the EMA Q&As on GDP RequirementsThe European Medicines Agency (EMA) provides answers to frequently asked questions on Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) on its website, which have been compiled and agreed by the GMP/GDP Inspectors Working Group. Read more
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ICH Q13: Final Version of Guideline for Continuous Manufacturing publishedBack in 2018, the ICH had begun work on a guideline titled "CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS Q13". A draft was published in mid-2021. Now ICH has approved the final version. Read more
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EMA: IRIS Guides Revised AgainAt the end of November and in mid-December 2022, the "IRIS guide to registration and RPIs" was updated again. The "IRIS guide for applicants" has also been revised and is now valid as version 2.13. The latest versions of both documents are available on the EMA website. Read more
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Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines
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Implementation of the European Pharmacopoeia Supplement 11.2 – Notification for CEP holdersSupplement 11.2 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 July 2023, and to follow the instructions given below. Read more
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Update on the EMA Checklists for Changes & VariationsThe European Medicines Agency has published pre-submission checklists for certain procedure types. In particular the Validation Checklist for Type II (non)clinical variations has now been updated. Read more
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Update on the EMA Guidance for Applicants/MAHs involved in GCP InspectionsThe EMA published the revised Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by EMA, Version 3.1. By this revision only the GCP section of the document has been amended. Read more
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ICH Q3C: Corrected Version of the Guideline for Residual Solvents PublishedSince the end of April 2022, the revision of the "ICH guideline Q3C (R8) on impurities: guideline for residual solvents" of the ICH (INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE) can be consulted on the ICH website under the heading "Quality Guidelines". This version has now been corrected and published in its new form. Read more
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Final do período de transição para submissão de novos pedidos iniciais de ensaios clínicos - Regulamento Europeu de Ensaios Clínicos n.º 534/2014 de 16 de abrilO Regulamento Europeu de Ensaios Clínicos n.º 534/2014 de 16 de abril, entrou em aplicação a 31 de janeiro de 2022 em todos os países da União Europeia, com o lançamento do Sistema de Informação de Ensaios Clínicos (CTIS), tendo-se iniciado simultaneamente o período de transição. Assim, de 31 de janeiro de 2022 a 30 de janeiro de 2023, os promotores de ensaios clínicos podem optar por submeter os seus pedidos iniciais de ensaios clínicos ao abrigo da Lei de Investigação Clínica (decorrente da Diretiva 2001/20/CE de 04 de abril) através da submissão de processos a nível nacional, no RNEC, ou ao abrigo do Regulamento Europeu de Ensaios Clínicos, através do CTIS. Read more
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Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of new paragraph on control of N-nitrosaminesAt its 174th session in November 2022, the European Pharmacopoeia (Ph. Eur.) Commission adopted the revised general monographs Substances for pharmaceutical use (2034) and Pharmaceutical preparations (2619), which now include a paragraph explaining the Ph. Eur. approach to N-nitrosamine impurities. This approach was defined based on the comments received during the last round of public consultation in Pharmeuropa together with recent feedback from Heads of Medicines Agency and European Medicines Agency groups and from the national competent authorities of non-EU Ph. Eur. member states. Read more
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Pharmeuropa 35.1 just releasedAll new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 35.1 is 31 March 2023. Read more
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ICH M13 draft Guideline reaches Step 2 of the ICH processThe ICH M13A draft Guideline on Bioequivalence for Immediate-Release Solid Oral Dosage Forms reached Step 2 of the ICH process on 20 December 2022. Read more
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Expert Task Force issues new Version of CCS GuidelinePast February, the ECA Foundation's CCS Task Force issued the first version of a Contamination Control Strategy Guideline to assist its members in meeting this requirement according to the new Annex 1 draft. This first version was based on the second draft of the Annex 1 revision. After completion, the ECA decided to also share it publicly free of charge to support companies and facilities for which the new Annex 1 is relevant. Read more
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Revised general chapter on rubber closures published in the Ph. Eur. Supplement 11.1The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published the revised general chapter on Rubber closures for containers for aqueous parenteral preparations, for powders and for freeze-dried powders (3.2.9) in European Pharmacopoeia Supplement 11.1, with an implementation date of 1 April 2023. Read more
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Qualification of Suppliers - What needs to be considered?According to the EU GDP Guidelines, wholesale distributors must obtain their supplies of medicinal products only from persons who themselves hold a wholesale distribution authorisation or a manufacturing authorisation which covers the product in question. Thus, all suppliers must be qualified in an adequate way. But what is the rationale for this point and how to implement the requirements? Read more
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USP issues Chapter "Elemental Impurities-Limits" for CommentsThe second revision of the ICH "Guideline for Elemental Impurities Q3D(R2)" was finalised in April 2022 and is available on the ICH website under the heading "Quality Guidelines". As a result of this revision, the chapter "<232> Elemental Impurities-Limits" of the USP has now been revised and published for comments on the USP Pharmacopeial Forum website. Read more
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EMA Evaluates Access to Raw Data from Clinical TrialsThe EMA’s Committee for Medicinal Products for Human use (CHMP) assesses initial regulatory submissions and post-authorization applications "on the basis of a comprehensive scientific evaluation of the quality, safety and efficacy of medicinal products". According to the CHMP, the clinical assessment is currently mainly based on data from clinical summaries and clinical study reports. This data is provided in a format that does not directly allow disaggregation or any other form of further analysis. However, regulators may benefit from having access to raw data during the assessment of the medicinal product. For example, access to raw data can assist regulators in understanding the submitted evidence and therefore support regulatory decisions on the benefit-risk assessment of the product. Read more
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ETF warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2EMA’s Emergency Task Force (ETF) has cautioned that monoclonal antibodies currently authorised for COVID-19 are unlikely to be effective against emerging strains of SARS-CoV-2. Read more
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Autorização de comercialização de medicamentos sem autorização ou registo válidos em Portugal (SAR): revisão do procedimentoConforme previsto no Estatuto do Medicamento, o Infarmed pode autorizar a comercialização de medicamentos sem autorização ou registo válidos em Portugal (SAR), por razões de saúde pública. Read more
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EMA recommends withdrawal of pholcodine medicines from EU marketEMA’s safety committee, PRAC, has concluded its review of medicines containing pholcodine, which are used in adults and children to treat non-productive (dry) cough and, in combination with other active substances, for the treatment of symptoms of cold and flu, and has recommended the revocation of the EU marketing authorisations for these medicines. Read more
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Real-World Data: EMA´s Good Practice GuideThe European Medicines Agency (EMA) has published for public consultation a Good Practice Guide for the use of the Metadata Catalogue of Real-World-Data Sources. According to the agency it is the first guide worldwide to focus on metadata to empower systematic integration of Real-World-Evidence (RWE) in medicines regulation. The guide provides recommendations on how to use the real-world metadata catalogue that is currently being built and in late 2023 will replace the existing catalogue of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). The guide will help to identify suitable RWD sources and describes the metadata elements that will be used. Read more
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Amendment to the CTR on IMP LabellingAs previously reported in the news entitled Labeling Requirements for IMPs Amended the European Commission (EC) revised the current labelling requirements provided in the Clinical Trials Regulation (CTR) for investigational medicinal products (IMPs) regarding expiry dates by means of a Delegated Regulation. Now the regulation has been published in the Official Journal of the European Union. Read more
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Best practices to fight antimicrobial resistanceThe International Coalition of Medicines Regulatory Authorities (ICMRA) highlights successful regulatory and non-regulatory interventions used in different countries to address the growing public health problem of antimicrobial resistance (AMR) in a new report published today. Read more
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EMA: Q&A Documents on Centralised Procedures updated againThe Questions & Answers (Q&A) documents relating to centralised marketing authorisation procedures, last revised in June, have now been updated again and published on the European Medicines Agency (EMA) website. These Q&As are intended to provide guidance and guidelines for marketing authorisation holders and applicants of centralised procedures and provide answers to potential questions at different stages of the centralised marketing authorisation application process. Read more
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APIC: New Update of the ICH Q7 "How to do" DocumentThe latest version (version 16) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for active pharmaceutical ingredients was finalised in July 2022 and published on the new website of the APIC (Active Pharmaceutical Ingredients Committee) at the end of October. The document is further intended to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how it can be interpreted. Read more
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Temperature Mapping for the Qualification of Storage AreasIn the Pharmacopeial Forum, PF 48(5), a stimuli article entitled "The Use of Temperature Mapping for the Qualification of Storage Areas for the Proper Temperature Storage of Drug Products" was published. It was written by Chris Anderson, Desmond G. Hunt, and Robert Seevers. Read more
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New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndromeOn 29 September 2022, EMA’s safety committee (PRAC) recommended new measures to reduce the risk of respiratory failure (severe breathing difficulties that may be life-threatening) and sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) when using terlipressin-containing medicines in people with type 1 hepatorenal syndrome (type 1 HRS) (serious kidney problems in people with advanced liver disease). Read more
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Vulnerabilities in global Supply Chains: Reasons and possible SolutionsThe EU Commission has published a document on a "Structured Dialogue on the security of medicines supply". The document is based on a mandate for a dialogue of different actors in the value chain of medicines from manufacturing, authorities, non-governmental organisations as well as from research. The aim was to gain a better understanding of the functioning of global pharmaceutical supply chains and to identify causes of potential vulnerabilities. The document now published presents the most important results of the analysis of supply security and possible measures. Read more
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EMA publishes ICH M11 (CeSHarP) for CommentsThe International Council for Harmonisation (ICH) approved the draft Guidance M11 for a harmonized electronic study protocol in clinical trials (CeSHarP) for public comment in Step 2b of the ICH process on September 27, 2022. Now, the EMA's Committee for Human Medicinal Products (CHMP) published it for information and comment in the EU on October 26, 2022. The comment period runs until February 26, 2023. Read more
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Recomendações sobre medidas de minimização do risco de reações adversas graves: medicamentos da classe de Inibidores das JAK usados em doenças inflamatóriasO Comité de Avaliação do Risco em Farmacovigilância (PRAC) da Agência Europeia de Medicamentos (EMA na sigla em inglês) recomendou a implementação de medidas para minimizar o risco de ocorrência de efeitos indesejáveis graves associados aos medicamentos da classe de inibidores das Janus quinases (JAK), quando utilizados para tratar diversas doenças inflamatórias crónicas. Estes efeitos indesejáveis incluem doenças cardiovasculares, coágulos sanguíneos, cancro e infeções graves. Read more
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EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders
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ICH M11 guideline, clinical study protocol template and technical specificationsThe purpose of this new harmonised guideline is to introduce the clinical protocol template and the technical specification to ensure that protocols are prepared in a consistent fashion and provided in a harmonised data exchange format acceptable to the regulatory authorities. The ICH M11 Clinical Electronic Structured Harmonised Protocol Template provides comprehensive clinical protocol organization with standardized content with both required and optional components. The Technical Specification that are acceptable to all regulatory authorities of the ICH regions presents the conformance, cardinality, and other technical attributes that enable the interoperable electronic exchange of protocol content with a view to develop an open, non-proprietary standard to enable electronic exchange of clinical protocol information. Read more
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Nitrosamine Impurities: Further Update of EMA's Question and Answer DocumentThe Q&A document developed by EMA and CMDh is updated at irregular intervals to reflect the latest knowledge. On 12 October 2022, the EMA published on its "What's new" website a new update of the Q&A document "Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamin impurities in human medicinal products" - now the 14th revision. Read more
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ICH M11 draft Guideline reaches Step 2 of the ICH processThe ICH M11 draft Guideline on Clinical electronic Structured Harmonised Protocol (CeSHarP), Technical Specification and Template reached Step 2 of the ICH process on 27 September 2022. Read more
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EMA divulga novas recomendações para aprovação de vacinas COVID-19O Comité de Medicamentos de Uso Humano (CHMP) da Agência Europeia de Medicamentos (EMA), recomendou hoje, numa reunião extraordinária, a aprovação das vacinas Comirnaty e Spikevax COVID-19 para crianças a partir dos 6 meses de idade, e também, a aprovação da segunda vacina Spikevax adaptada. Read more
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EDQM Publishes new Document on Revised Ph. Eur. General Chapter 2.2.46. Chromatographic Separation TechniquesA revised general chapter 2.2.46. Chromatographic separation techniques has been published in Ph. Eur. 11.0. The implementation date is 01 January 2023. Read more
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New vaccine to protect people in the EU and worldwide against dengueEMA’s human medicines committee (CHMP) has adopted a positive opinion for Dengue Tetravalent Vaccine (live, attenuated) Takeda, used to prevent disease caused by dengue virus serotypes 1, 2, 3 and 4 in people from four years of age. Read more
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EMA lança uma consulta pública sobre o guia de boas práticas para a utilização do catálogo de meta-dados do mundo realEm adiantamento ao lançamento do catálogo de meta-dados do mundo real, no final de 2023, o projeto sobre o guia de boas práticas para a utilização deste catálogo propõe recomendações aos reguladores, investigadores, detentores de dados, empresas farmacêuticas e outras partes interessadas sobre como utilizá-lo a fim de identificar fontes de dados reais adequadas para estudos, incluindo casos de utilização. Read more
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Shortages and Crisis Preparedness: EMA Publishes List of the Main Therapeutic Groups of Medicinal ProductsOn 8 July 2022 the EMA published the List of the Main Therapeutic Groups of Medicinal Products that are used for emergency care, surgeries and intensive care. This list was established by the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). Read more
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USP: Stimuli Article on Mutagenic Impurities published for CommentsSince the beginning of September 2022, the stimuli document "Mutagenic Impurities and Potentially Mutagenic Impurities in the USP-NF" has been published for comments on the website of the Pharmacopeial Forum of the USP. Comments and observations on this draft can be submitted until 30 November 2022. Read more
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List of Documents Needed during GVP InspectionsThe EMA previously published a guidance for applicants / MAHs involved in GMP and GCP inspections. Now this document has been updated to also include Good Pharmacovigilance Practice (GVP) inspections. The guidance describes the necessary documents and information that must be made available via the IRIS portal. It has to be ensured that inspection sites are notified and that they are inspection ready and have relevant documentation, facilities and personnel readily available for the GVP inspection. Read more
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Implementation of the European Pharmacopoeia Supplement 11.1 – Notification for CEP holdersSupplement 11.1 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2023, and to follow the instructions given below. Read more
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New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndromeEMA’s safety committee (PRAC) recommended new measures to reduce the risk of respiratory failure (severe breathing difficulties that may be life-threatening) and sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage) when using terlipressin-containing medicines in people with type 1 hepatorenal syndrome (HRS-1) (kidney problems in people with advanced liver disease). Read more
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EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal productsEMA is launching a pilot to support the translation of basic research developments into medicines that could make a difference in patients’ lives in the European Economic Area (EEA). The pilot is open to academic sponsors and non-profit organisations who are developing advanced therapy medicinal products (ATMPs). These medicines for human use are based on genes, tissues or cells and might offer ground-breaking treatment options to patients. Read more
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Avaliação do risco de presença de nitrosaminas nos medicamentos/ Review on the risk of nitrosamine impurities in human medicinesA avaliação do risco de presença de nitrosaminas nos medicamentos foi iniciada em 2019( Circular Informativa nº 145/DC/100.20.200 de 27/09/2019, Circular Informativa nº 051/DC/100.20.200 de 11/02/2020 e Circular Informativa nº 081/DC/100.20.200 de 08/04/2020) com o objetivo de os titulares de Autorização de Introdução no Mercado efetuarem a revisão dos medicamentos que contêm substâncias ativas sintetizadas quimicamente para verificar a presença de nitrosaminas e testar todos os medicamentos com potencial risco, reportando, em ambos os casos, os resultados às autoridades nacionais competentes. Read more
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PIC/S also publishes revised Annex 1 (Manufacture of Sterile Medicinal Products)On 22 August 2022, the EU Commission published the long-awaited revised version of Annex 1 "Manufacture of Sterile Medicinal Products". Almost simultaneously with the EU Commission, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) also published the revised Annex 1 (Manufacture of Sterile Medicinal Products) to the Guide to Good Manufacturing Practice for Medicinal Products on 9 September 2023. Read more
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European Pharmacopoeia Supplement 11.1 now availableThe European Pharmacopoeia (Ph. Eur.) Supplement 11.1 is now available and will be applicable in 39 European countries as of 1 April 2023. Read more
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EMA e HMA confirmam interpermutabilidade dos medicamentos biossimilaresA Agência Europeia de Medicamentos (EMA) e o grupo de Chefes das Agências de Medicamentos (HMA) dos Estados-membros da União Europeia, emitiram uma declaração conjunta, confirmando que os medicamentos biossimilares aprovados na União Europeia (UE), podem ser utilizados em alternativa ao seu medicamento de referência ou a outro biossimilar equivalente. Read more
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Labeling Requirements for IMPs AmendedFollowing a 1-month feedback period on the draft published in June this year the European Commission (EC) finally adopted on 6 September the revised Annex VI to Regulation (EU) No 536/2014 (Clinical Trials Regulation, CTR) as regards labelling requirements for IMPs. The Regulation will enter into force on the twentieth day following its publication in the Official Journal of the European Union and will be binding and directly applicable in all Member States. Read more
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Publication of revised PIC/S Annex 1The revised Annex 1 to the PIC/S GMP Guide on the manufacture of sterile products has been published and will enter into force on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. The date of entry into operation is aligned with that of the revised EU Annex 1, which is identical to PIC/S Annex 1 (with some very minor editorial differences). Read more
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EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccinesEMA’s human medicines committee (CHMP) has recommended converting the conditional marketing authorisations of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer’s vaccine) and Spikevax (Moderna’s vaccine) into standard marketing authorisations. These no longer need to be renewed annually. All other obligations for the companies remain in place. Read more
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GDP Non-Compliance Report: No GDP conform Quality SystemThe competent authority of Germany (Thuringian State Authority for Consumer Protection / Thüringer Landesamt für Verbraucherschutz) has entered a new GPD Non-Compliance Report dated 21 July 2022 into the EudraGMDP database. Read more
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Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approvalEMA’s human medicines committee (CHMP) has recommended authorising an adapted bivalent vaccine targeting the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2. This recommendation will further extend the arsenal of available vaccines to protect people against COVID-19 as the pandemic continues and new waves of infections are anticipated in the cold season. Read more
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Revised OCABR Guideline for Pandemic COVID-19 vaccine (mRNA) now availableThe Guideline for Pandemic COVID-19 vaccine (mRNA), in force since 12 November 2020, has been updated to accommodate bivalent mRNA COVID-19 vaccines. Read more
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EMA Publishes Comments Received on ICH Q2(R2) and Q14In March 2022 the European Medicines Agency (EMA) published the ICH guidelines Q2(R2) on validation of analytical procedures and the ICH Q14 on analytical procedure development for public consultation (Step 2b). The deadline for submitting comments to the draft versions was 31 July 2022. For further information, please see ICH Guidance Q14 / Q2(R2) - Analytical Method Development/Method Validation Published for Consultation. Read more
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New general chapter on implementation of pharmacopoeial procedures published in the 11th Edition of the European PharmacopoeiaA new general chapter, Implementation of pharmacopoeial procedures (5.26), has just been published in the 11th Edition of the European Pharmacopoeia (Ph. Eur.). The text was adopted by the Ph. Eur. Commission at its session in November 2021. Read more
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EMA recomenda primeiras vacinas COVID-19 adaptadasO Comité de Medicamentos de Uso Humano (CHMP) da Agência Europeia de Medicamentos (EMA), recomendou a autorização de duas vacinas adaptadas, para fornecer proteção mais ampla contra o COVID-19. Read more
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Nitrosamines – Deadline extension for all CEP holders to complete step 3 Revision to the CEP (now 1 October 2023)The European medicines regulatory network has agreed to extend the deadline for submissions related to Step 3: variation to the marketing authorisation until 1 October 2023. This extension is intended to allow companies time to perform a thorough investigation and establish any required risk-mitigating actions. The deadline for Step 2: confirmatory testing remains unchanged: 26 September 2022. Read more
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Great Britain plans a New "Mark" for Medical Products as a Replacement to the CE MarkWith UK's exit from the EU (Brexit), a transition period also has started with regard to medical devices. The MHRA has now published plans on how to proceed after this transition period. Read more
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EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccineEMA’s human medicines committee (CHMP) has started a review of a conditional marketing authorisation application for Skycovion, a vaccine for protecting against COVID-19. Read more
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Nitrosamine Impurities: Extension of the Deadline for the Submission of VariationsEMA's Question and Answer document on nitrosamine impurities is addressed to marketing authorisation holders. This document describes the approach to review the manufacturing processes for chemically-synthesised and biological medicinal products and to do the risk assessments accordingly. Read more about which new deadlines for variations have to be observed and what has changed in the forms. Read more
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CTIS & EudraVigilance - Update for Sponsors of Clinical TrialsThe EMA provides guidance for sponsors who have to report SUSARs via EudraVigilance originated in the context of clinical trials. In addition the updated document "Key Information for Sponsors on CTIS" has been published. Read more
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USP-NF Stimuli Article on Consistent NMR TerminologyIn the Pharmacopeial Forum, PF 48(4), a stimuli article entitled "Consistent Terminology for Advancement of NMR Spectroscopy" was published. The stimuli article is available on PF Online. The deadline for submitting comments is September 30, 2022. Read more
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EMA recommends approval of Imvanex for the prevention of monkeypox diseaseEMA’s human medicines committee (CHMP) has recommended extending the indication of the smallpox vaccine Imvanex to include protecting adults from monkeypox disease. Read more
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Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-makingEMA has endorsed a joint statement calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making published today by the International Coalition of Medicines Regulatory Authorities (ICMRA). Read more
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EMA updates eAFs for Variations for Medicinal Products for Human and Veterinary UseThe electronic application forms for submission of variations (eAFs) for medicinal products for human and veterinary use were updated in June and are listed in the latest versions on EMA's eSubmission website. The revision of the forms has not caused a change in the versioning of the documents, so both forms keep the version number "eAF Version Number: 1.26.0.0". Read more
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The latest Updates of the EMA's Question and Answer Document on Nitrosamine ContaminationAfter the last revision of the Q&A document on nitrosamine contamination in February this year, three further updates (Rev. 8 of 24 March, Rev. 9 of 20 May and Rev. 10 of 23 June 2022) have been made in the period of 12 weeks. Read more
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Towards better prevention of medicine shortages in the EUEMA has published a PDF icon guidance for patients’ and healthcare professionals’ organisations with key principles and examples of good practices to support them in preventing and managing shortages of human medicines. Read more
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EMA launches pilot project on analysis of raw data from clinical trialsEMA has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorisation applications (MAAs) for new medicines as well as post-authorisation applications and to explore the practical aspects of the submission and analysis of such data. Read more
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ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccinesThe European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) are recommending that second booster doses of mRNA COVID-19 vaccines be considered for people between 60 and 79 years old and people with medical conditions putting them at high risk of severe disease. Read more
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Further measures to identify and address medicine shortages during public health emergencies adoptedOn 7 July 2022, EMA’s Medicines Shortages Steering Group (MSSG) adopted the PDF icon list of the main therapeutic groups of medicines used in emergency care, surgery and intensive care. The list forms the basis from which EMA will draw up concrete lists of critical medicines needed to deal with a specific ‘public health emergency’ or a ‘major event’. Read more
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Pharmeuropa 34.3 just releasedAll new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 34.3 is 30 September 2022. Read more
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Drug Shortages: EMA asks Companies to register a Single Point of ContactMarketing Authorisation Holders (MAHs) can now register a central contact point, the so-called Industry Single Point of Contact (i-SPOC). This function is to inform the EMA about the supply and availability of critical medicines. Read more
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Global regulators agree on key principles on adapting vaccines to tackle virus variantsOn 30 June, regulators from around the world discussed emerging evidence to support adaptation of COVID-19 vaccines as the SARS-COV-2 virus continues to evolve during a workshop co-chaired by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). The meeting focused on identifying key principles to support the adaption of COVID-19 vaccines to better match Omicron variants of concern, and on ensuring global regulatory alignment. Read more
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CTIS & EudraVigilance - Update for Sponsors of Clinical TrialsThe EMA launched the enhanced EudraVigilance system in November 2017 to support the reporting and analysis of suspected adverse reactions (SARs) from clinical trials and the post-approval phase of medicines. Based on a recommendation from the Pharmacovigilance Risk Assessment Committee (PRAC), the mandatory use of the International Standard on "Individual Case Safety Report" (ICSR) revision 3 (ICH-E2B(R3)) for all submissions to EudraVigilance will be implemented starting June 30, 2022. The use of the ICH E2B (R2) format will therefore be phased out (for more information, see Change management for the EudraVigilance system). Read more
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Monkeypox: EMA starts review for ImvanexEMA’s human medicines committee (CHMP) has started a review of data to extend the use of the smallpox vaccine Imvanex to include protecting people from monkeypox disease. Read more
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First gene therapy to treat severe haemophilia AEMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Roctavian (valoctocogene roxaparvovec) for the treatment of severe haemophilia A in adults who do not have factor VIII inhibitors (auto-antibodies produced by the immune system which make factor VIII medicines less effective) and no antibodies to adeno-associated virus serotype 5 (AAV5). Read more
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EMA: Another Update of the Q&As on Parallel DistributionAlready in April 2022, the "Frequently asked questions about parallel distribution" were revised and published on the EMA website. You could arelady read about the updates contained therein under "Update of the EMA Q&As on parallel Distribution of Medicinal Products". Now, the Q&As have been updated again and supplemented. Read more
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New Guidance Documents for GCP InspectionsOn January 31, 2022, the EMA's Clinical Trials Information System (CTIS) went live in accordance with the Clinical Trials Regulation (EU) No 536/2014 (CTR). Following the previously published List of documents needed during GCP inspections, the EMA issued a set of updated documents on planning and conducting GCP inspections on its website. Read more
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MHRA introduces external consultants as Compliance Monitors in CompaniesThe UK Medicines and Healthcare products Regulatory Agency (MHRA) has started to pilot a new so-called Compliance Monitor Process for appropriate GMP and GDP Inspection Action Group (IAG) cases. Read more
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New Version of the ICH Q3D Guideline for Impurities publishedSince the end of April 2022, the second revision of the "Guideline for Elemental Impurities Q3D(R2)" of the ICH (INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE) is available on the ICH website under the heading "Quality Guidelines". This version includes revisions and adaptations in Appendices 2 and 3. Appendix 5 has been added. Read more
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EMA guidance supports development of new antibioticsAs part of its efforts to support a global approach to the development of new antimicrobial medicines, EMA has published the final revised guideline on the evaluation of human medicines for the treatment of bacterial infections. Read more
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EMA tackles the Issue of Remote Batch CertificationEMA today opened a short, one-month public consultation on a draft question and answer document on remote certification of batches by the Qualified Person (QP): "Public Consultation concerning the physical Attendance and the Location of Personal Residency of The Qualified Person" (EMA/INS/169000/2022). Read more
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List of Documents Needed during GCP InspectionsThe EMA published guidance for applicants / MAHs involved in Good Clinical Practice (GCP) inspections. It includes a detailed list of documents to be provided to GCP inspectors. Read more
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RP for GDP: Which Duties can be Delegated?The area of responsibility of the Responsible Person for Good Distribution Practice (RP for GDP) is quite extensive. According to Chapter 2.2. of the EU GDP Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use - 2013/C 343/01), twelve task areas (No. i to xii) are covered. Read more
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Classification of Packaging ChangesPrior to submission of a variation whose classification is not provided for in Commission Regulation (EC) 1234/2008, a Marketing Authorization Holder (MAH) or a competent authority of a Member State may request the CMDh (Co-ordination group for Mutual recognition and Decentralized procedures – human) or the EMA (for centralized procedures) to provide a recommendation on the classification of the proposed change ("Article 5 Recommendations"). Read more
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What is a Pregnancy Prevention Programme?The European Medicines Agency, EMA, has published the "Guideline on good pharmacovigilance practices (GVP) Module XVI Addendum III - Pregnancy prevention programme and other pregnancy-specific risk minimisation measures" for public consultation. Comments can be submitted by 31 May 2022 via the EU survey tool. Read more
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Update of the EMA Q&As on parallel Distribution of Medicinal ProductsThe so-called "Frequently asked questions about parallel distribution" were updated in April 2022 and published on the EMA website. In July 2021 you could already read about the information provided by the EMA on parallel distribution of centrally authorised medicinal products, which has now been supplemented, revised and updated. Read more
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Comments on the new ICH Q9 Guideline Q9 (Quality Risk Management) publishedSince 2005, ICH Guideline Q9 has been the state of the art when it comes to quality risk management (QRM) in the GMP environment. Now it was time for a revision. For this purpose, the draft of a revised document was published in December last year by the ICH but also by the European Medicines Agency (EMA). With 33 pages, the draft was more extensive than the previous version with 19 pages. However, this was also due to the fact that each line was numbered for better commenting and line spacing was increased as a result. Read more
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MHRA Releases New Version of the Green GuideThe 2022 edition of the Rules and Guidance for Pharmaceutical Distributors (the "Green Guide"), compiled by the Medicines and Healthcare products Regulatory Agency (MHRA), was published. It provides an authoritative source of European good distribution practices and UK guidance, information and UK legislation on these activities. Read more
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Product Transfer: Is a Transfer Plan a required GMP Document?A frequently asked question in courses on product / technology transfer is: Is a transfer plan a required GMP document? Read more
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Outcome of the 172nd session of the European Pharmacopoeia Commission, March 2022The European Pharmacopoeia (Ph. Eur.) Commission held its 172nd session on 22 and 23 March 2022. The Commission adopted 78 texts at this session, to be published in Ph. Eur. Supplement 11.1 and be effective as of 1 April 2023. Read more
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ECDC e EMA emitem parecer sobre quartas doses de vacinas de mRNA COVID-19O Centro Europeu de Prevenção e Controlo de Doenças (ECDC) e a Agência Europeia de Medicamentos (EMA) concluíram ser ainda muito cedo para ser considerada, na população em geral, a administração de uma quarta dose de vacinas mRNA COVID-19 (Pfizer's Comirnaty e Moderna's Spikevax). Read more
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ICH Guidance Q14 / Q2(R2) - Analytical Method Development/Method Validation Published for ConsultationThe previous harmonised guideline Q2(R1) has been in force in its current form since 2005. At that time, it combined the two guidelines Q2A, which contained analytical methods for required validation parameters, and Q2B, the methodology guideline. Read more
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Centralised Procedures: Update of the Q&A DocumentIn March 2022, the European Medicines Agency (EMA) published on its website the updated and revised version of the "Questions & Answers (Q&A)" document "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure". These Q&As are intended to provide assistance and guidance to marketing authorisation holders and applicants of centralised procedures and to provide answers to possible questions related to post-authorisation issues. This includes, for example, explanations on how to deal with variation procedures or marketing authorisation extensions. Read more
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Pharmaceutical industry provides unpublished data on chemical substancesPreviously unpublished data on chemicals tested to develop medicines is now publicly available. The data is downloadable as IUCLID datasets – the global format for collecting, storing and sharing information on chemicals. Read more
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EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practiceEMA, in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC), has launched the Cancer Medicines Forum (CMF). Bringing together representatives from academic organisations and the European medicines regulatory network, the forum aims at advancing research into optimising cancer treatments and will contribute to foster high standards in cancer care in the European Union (EU). Read more
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New gene therapy to treat adult patients with multiple myelomaEMA has recommended a conditional marketing authorisation in the European Union (EU) for Carvykti (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies and whose cancer has worsened since they received their last treatment. Read more
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How often should GDP Self-Inspections be performed?According to the GDP guidelines, regular self-inspections should be performed. Read more
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Revision of the PIC/S GMP GuideThe PIC/S (Pharmaceutical Inspection Co-operation Scheme) already published a new version of its GMP Guide PE016 in February. This is due to the revision of EU Regulation No. 536/2014 on clinical trials. Annex 13 of the PIC/S document has now also been adapted to this. This is in line with the cooperation agreement between PIC/S and EMA, which stipulates that the PIC/S and EU GMP Guides should be aligned. Read more
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Updated Guidance relating to Clinical Trials during the COVID-19 PandemicThe Guidance on the management of clinical trials during the COVID-19 Pandemic has been updated. The key changes compared to version 4 from February 2021 are relating to updates with references to the EU Clinical Trials Regulation (CTR) No. 536/2014 which entered into application on 31 January 2022. Read more
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Information Duties and Responsibilities of CEP Holders - the new EDQM Public DocumentMarketing authorisation holders and applicants depend on a good cooperation with their suppliers of active pharmaceutical ingredients. As a rule, these suppliers have a Certificate of Suitability, CEP as well as all important information about the API. Read more
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Sessão de informação: Introdução à OMS e RMS para utilizadores do CTIS da Indústria Farmacêutica e Centros de EnsaioA Agência Europeia de Medicamentos (EMA na sigla em inglês) está a organizar uma sessão de informação sobre os serviços e atividades de dois sistemas de gestão de dados da EMA, a Organisation Management Service (OMS) e a Referentials Management Service (RMS), dirigidas para utilizadores do CTIS da Indústria Farmacêutica e dos Centros de Ensaio. A OMS é o sistema de gestão de dados que permite o registo de organizações a serem ser envolvidas nos ensaios clínicos submetidos no CTIS: Promotores, Organizações Terceiras (CROs), Centros de Ensaio e Titulares de AIM e a RMS é o sistema de gestão de dados que disponibiliza listas de referências e termos, como vias de administração e formas farmacêuticas. Read more
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New WHO Guidance on Data IntegrityIn recent years, the topic of data integrity has led to increased activity among international authorities, resulting in numerous guidelines issued by these institutions. Among others, the WHO (World Health Organization) published in the Technical Report Series, No. 996, 2016, as Annex 5 a "Guidance on good data and record management practices". Read more
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Hydroxyethyl-starch solutions for infusion recommended for suspension from the marketOn 11 February 2022, EMA’s safety committee, PRAC, recommended that the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion should be suspended across the European Union. These products were authorised as an addition to other treatments for plasma volume replacement following acute (sudden) blood loss. Read more
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EMA recomenda aprovação da vacina Spikevax para crianças dos 6 aos 11 anosO Comité de Medicamentos de Uso Humano (CHMP na sigla em inglês) da Agência Europeia de Medicamentos (EMA), recomendou a concessão de uma extensão de indicação para a vacina COVID-19 Spikevax, de forma a incluir o uso em crianças dos 6 aos 11 anos de idade. A vacina, desenvolvida pelo laboratório Moderna, já estava anteriormente aprovada para utilização em adultos e crianças a partir dos 12 anos (inclusive). Read more
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CMDh: Adjustments to the Guide for Electronic Submissions (eAF)A new version of the "Module 1: Administrative information Application form - User guide for the electronic application form for a Marketing Authorisation" was prepared in December 2021 and has now been published on the HMA (Heads of Medicines Agencies) website. This document is intended to serve as a supporting guide for the preparation of the electronic application form for the submission of medicinal products for human use and for the registration of traditional herbal medicinal products. Read more
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Final EMA Guidelines on Quality Requirements for IMPsThe final EMA Guidelines (Rev. 2) on the quality requirements for pharmaceutical and biological investigational medicinal products (IMPs) have been released on the EMA website together with an overview of comments received on the draft guidelines published last year. The date of coming into effect was 31 January 2022, which is also the application date of the Regulation (EU) No. 536/2014 on clinical trials (CTR). Read more
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EMA: Renewed Update of the Q&A Documents on "Centralised Procedures"In February 2022, the European Medicines Agency (EMA) published on its website the updated and revised versions of the Questions & Answers (Q&A) documents related to centralised marketing authorisation procedures. These Q&As are intended to provide guidance and guidelines for marketing authorisation holders and applicants of centralised procedures and provide answers to potential questions at different stages of the centralised marketing authorisation application process. Read more
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Active and Passive Shipping Systems and Transport EquipmentIn this article, we will provide some information and examples of active and passive shipping systems and equipment used for the transport of time and temperature sensitive pharma products. Read more
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Recomendação de suspensão do mercado das AIM das soluções para perfusão de hidroxietilamidoO Comité de Avaliação do Risco em Farmacovigilância (PRAC) da Agência Europeia de Medicamentos (EMA na sigla em inglês), recomendou1 que as autorizações de introdução no mercado (AIM) das soluções para perfusão de hidroxietilamido (HES na sigla em inglês) sejam suspensas em toda a União Europeia. Read more
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EU: Strengthening the EMAA regulation strengthening the role of the EMA in crisis preparedness and management for medicinal products and medical devices has been published in the Official Journal of the EU (Regulation (EU) 2022/123 "on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices"). Read more
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Vacinas administradas noutros paísesA vacinação contra a COVID-19 é uma prioridade global para a proteção da saúde pública. Read more
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Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
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EDQM OCCL study reports low compliance of “kids’ cosmetics”A study by the European Network of Official Cosmetics Control Laboratories (OCCLs) indicates that “kids’ cosmetics” continue to fail to comply with European quality and safety regulations, finding that 25% of samples were non-compliant with legislative requirements. Decorative cosmetics, including temporary hair colour products (54% of the samples), nail varnishes (39%), body and face paints (25%), eye products (22%), lip products (21%) and perfumes (22%) were frequently rejected. This study was co-ordinated by the European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe as part of its effort to enhance proper market surveillance in Europe. Read more
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GMP Requirements for Supplier QualificationSupplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. It should provide an appropriate level of confidence that suppliers, vendors and contractors are able to supply consistent quality of materials, components and services in compliance with regulatory requirements. An integrated supplier qualification process should also identify and mitigate the associated risks of materials, components and services. But what are the exact requirements? Read more
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A stronger role for EMAThe regulation reinforcing EMA’s role in crisis preparedness and management for medicinal products and medical devices has been published today in the Official Journal of the EU. This officially concludes the legislative process for an important pillar of the European Health Union. Read more
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New gene therapy treatment for patients with relapsed or refractory large B-cell lymphomaEMA has recommended granting a marketing authorisation in the EU for Breyanzi (lisocabtagene maraleucel), a gene therapy for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), whose cancer has come back or who have not responded to treatment after two or more lines of systemic therapy. Read more
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EMA publishes Guidance on Companion DiagnosticsAs May 2022 approaches, the need for guidance on the In Vitro Diagnostics Regulation (IVDR) is growing. Regarding the topic of companion diagnostics, the EMA published a draft document at the end of last year about the consultation procedure between the EMA and a Notified Body. The 10-page document describes how the consultation procedure between the EMA and a Notified Body should be conducted when it comes to companion diagnostics. Reference is made to Article 48 (3.4.5 and 8) of the IVD Regulation 2017/746. Read more
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EMA: Draft Guidance for Centralised Procedures open for CommentsIn December 2021, the European Medicines Agency (EMA) published the draft of the "Guideline on the acceptability of names for human medicinal products processed through the centralised procedure" for public comment on their website. Read more
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EMA: Updates of the Q&A Documents for "Centralised Procedures"In December 2021, the European Medicines Agency (EMA) published the updated and revised versions of the "Questions & Answers (Q&A)" documents related to centralised marketing authorization procedures on their website. These Q&A catalogs are intended to provide assistance and guidance to marketing authorization holders and centralised procedure applicants, and provide answers to potential questions at various stages of the centralised marketing authorization application process. Read more
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International regulators’ recommendations on COVID-19 vaccines and the Omicron variantInternational regulators have published a report today highlighting their discussions on the effectiveness of current vaccines against the COVID-19 Omicron variant, regulatory requirements for a variant vaccine and considerations on clinical study design. The workshop on the global response to the COVID-19 Omicron variant was organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) and took place on 12 January 2022. Read more
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Implementation of the European Pharmacopoeia Supplement 10.8 – Notification for CEP holdersSupplement 10.8 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 July 2022, and to follow the instructions given below. Read more
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EMA: Draft Guidance for Centralised Procedures open for CommentsIn December 2021, the European Medicines Agency (EMA) published the draft of the "Guideline on the acceptability of names for human medicinal products processed through the centralised procedure" for public comment on their website. Read more
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The GDP Non-Compliance Reports of 2021 - An OverviewWholesale trade in medicinal products requires a wholesale authorisation. A certificate of Good Distribution Practice (GDP) is issued to a wholesale distributor by the national competent authority. Read more
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Novo Regulamento Europeu de Ensaios Clínicos entra em aplicação a 31 de janeiroA condução dos ensaios clínicos na União Europeia (UE) será objeto de uma alteração profunda quando o Regulamento dos Ensaios Clínicos (Regulamento (UE) n.º 536/2014) entrar em aplicação a 31 de janeiro de 2022. O regulamento harmoniza os processos de submissão, avaliação e supervisão dos ensaios clínicos na UE através de um ponto de entrada único, o Sistema de Informação de Ensaios Clínicos (CTIS). Read more
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Proposal for New General USP Chapter on Quality Attributes of Starting Materials for the Chemical Synthesis of Therapeutic PeptidesIn the Pharmacopeial Forum, PF 48(1), a proposal for a new general chapter <1504> Quality Attributes of Starting Materials for the Chemical Synthesis of Therapeutic Peptides was published. The draft of the new chapter is available on PF Online. (Please note: a one-time registration is required to access the Pharmacopeial Forum.) The deadline for submitting comments is March 31, 2022. Read more
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EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
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Pharmeuropa 34.1 just releasedAll new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 34.1 is 31 March 2022. Read more
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Publicado Regulamento (UE) 2021/2282 do Parlamento Europeu e do Conselho relativo à avaliação das tecnologias da saúdeFoi hoje publicado no Jornal Oficial da União Europeia o Regulamento (UE) 2021/2282 do Parlamento Europeu e do Conselho relativo à avaliação das tecnologias da saúde e que altera a Diretiva 2011/24/EU. Read more
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WHO publishes Guidance on Safe Production and Quality Control of Monoclonal AntibodiesAs early as October 1991, the WHO Expert Committee enacted the first guidelines for the quality assurance of monoclonal antibodies for human use. In the following 30 years, there have been many scientific and technical advances in both the production and quality assurance of monoclonal antibodies (mAbs). In particular, the use of recombinant DNA (rDNA) and cloning technologies have contributed significantly. Read more
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Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics
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COVID-19 - EMA recomenda autorização de dois medicamentosO Comité de Medicamentos de Uso Humano (CHMP na sigla em inglês) da Agência Europeia de Medicamentos (EMA na sigla em inglês) recomendou a autorização de dois medicamentos para a COVID-19. Read more
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Guideline on the acceptability of names for human medicinal products processed through the centralised procedureBased on the experience gathered by the Name Review Group (NRG) since the last revision of the guideline in December 2007, it became apparent that some areas of the guideline would benefit from further clarifications, in particular with regards to the requirements for acceptability and submission of proposed (invented) names of medicinal products processed through the centralised procedure. Read more
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CEPs: New IT Application of the EDQMIn October 2021, the EDQM (European Directorate for the Quality of Medicines & HealthCare) introduced a new IT application for handling and managing CEP applications. This resulted in some innovations and changes, especially in the communication between the applicant and the EDQM. Read more
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ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic riskThis guideline emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use. Read more
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International regulators stress continued need for COVID-19 therapeuticsEMA has endorsed a statement by the International Coalition of Medicines Regulatory Authorities (ICMRA) that urges all stakeholders, including researchers, pharmaceutical industry, healthcare professionals, health research funding agencies and research institutions, to continue their focus on developing therapeutics to treat and prevent COVID-19 in patients around the world. Read more
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APIC: Update of the ICH Q7 "How to do" DocumentThe latest version (version 15) of the "How to do" document - Interpretation of ICH Q7 Guide and "Review form" for APIs was finalised and published on the APIC website in July 2021. It is also intended to facilitate the implementation of the ICH Q7 Guideline and provides recommendations on how to interpret it. Read more
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How to use Real-World Data for Benefit-Risk AssessmentFollowing the draft guideline published in September 2020, the European Medicines Agency (EMA) published the final guideline on the use of real-world data (RWD) for benefit-risk assessment. According to the agency, the guideline addresses "the methodological, regulatory and operational aspects involved in using registry-based studies to support regulatory decision-making". In addition, the U.S. Food & Drug Administration (FDA) recently issued several draft guidelines on the use of RWD for drug and biological product submissions. Read more
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EMA starts rolling review of Valneva’s COVID-19 vaccine (VLA2001)EMA’s human medicines committee (CHMP) has started a rolling review of VLA2001, a COVID-19 vaccine being developed by Valneva. Read more
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EMA: Renewed Update of the Q&A Catalogue on "Centralised Procedures"In October and November, the European Medicines Agency (EMA) once more published on its website the updated and revised version of the "Questions & Answers (Q&A)" document related to questions before and during the submission of a centralised procedure. Read more
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WHO publishes Guidance on Safe Production and Quality Control of Monoclonal AntibodiesAs early as October 1991, the WHO Expert Committee enacted the first guidelines for the quality assurance of monoclonal antibodies for human use. In the following 30 years, there have been many scientific and technical advances in both the production and quality assurance of monoclonal antibodies (mAbs). In particular, the use of recombinant DNA (rDNA) and cloning technologies have contributed significantly. Read more
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Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11EMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 5 to 11. The vaccine, developed by BioNTech and Pfizer, is already approved for use in adults and children aged 12 and above. Read more
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A vision for use of real-world evidence in EU medicines regulationEnabling the use of real-world evidence (RWE) and establishing its value for regulatory decision-making on the development, authorisation and supervision of medicines in Europe by 2025: this is the vision of European regulators as outlined in an article from Peter Arlett, Head of Data Analytics and Methods at EMA, Jesper Kjær, Director of Data Analytics Centre at the Danish Medicines Agency, Karl Broich, President of the Federal Institute for Drugs and Medical Devices (BfArM), and Emer Cooke, EMA's Executive Director, published in Clinical Pharmacology & Therapeutics. Read more
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EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID 19EMA has started evaluating an application for marketing authorisation for the oral antiviral medicine Lagevrio (molnupiravir). Lagevrio, which is being developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics, is intended for the treatment of COVID-19 in adults. Read more
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GDP Certificates and Wholesale Authorisations Automatically Extended until the End of 2022In 2020 the European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have developed a question-and-answer (Q&A) document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. A revision published in April 2020 stated that "the validity of GDP certificates should be extended until the end of 2021 without the need for further action from the holder of the certificate." Read more
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EMA starts review of Paxlovid for treating patients with COVID-19EMA is reviewing currently available data on the use of Paxlovid (PF-07321332/ritonavir), an oral treatment for COVID-19 developed by Pfizer. EMA is starting this review to support national authorities who may decide on its early use for COVID-19, for example in emergency use settings, prior to marketing authorisation. Read more
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EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Xevudy (sotrovimab). The applicant is GlaxoSmithKline Trading Services Limited, who developed the medicine together with Vir Biotechnology. Read more
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EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, NuvaxovidEMA has started evaluating an application for conditional marketing authorisation for Novavax’s COVID-19 vaccine, Nuvaxovid (also known as NVX-CoV2373). The assessment will proceed under an accelerated timeline, and an opinion on the marketing authorisation could be issued within weeks if the data submitted are sufficiently robust and complete to show the efficacy, safety and quality of the vaccine. Read more
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First-in-class medicine recommended for treatment of rare blood vessel inflammationEMA has recommended granting a marketing authorisation in the European Union (EU) for Tavneos (avacopan), a first-in-class medicine to treat adult patients suffering from two forms of a rare multisystem autoimmune condition. Granulomatosis with polyangiitis and microscopic polyangiitis are forms of the autoimmune condition called anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, in which the immune system attacks small to medium-sized blood vessels in the body. Tavneos is to be used in combination with rituximab or cyclophosphamide - two medications used to treat certain autoimmune diseases and types of cancer. Read more
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ICH S1B Carcinogenicity: testing for carcinogenicity of pharmaceuticalsGuidance on approaches for evaluating the carcinogenic potential of pharmaceuticals. It embraces all pharmaceutical agents that need carcinogenicity testing as indicated in the ICH S1A. Read more
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Compassionate Use: EMA supports Submission of Medicinal Product InformationTo support voluntary submissions of medicinal product information for medicinal products supplied in the European Union (EU) or the European Economic Area (EEA) that fall out of scope of the Article 57 requirements (e.g. parallel importation, emergency use, compassionate use), new 'Legal basis' values will be made available in the Article 57 database. Read more
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HMA e EMA lançam piloto para promover o reposicionamento de medicamentosOs Chefes da Rede de Agências de Medicamentos (HMA na sigla em inglês) - que inclui o Infarmed - e a Agência Europeia de Medicamentos (EMA na sigla em inglês) estão a lançar um projeto-piloto para promover o reposicionamento de medicamentos como seguimento das discussões realizadas no âmbito do grupo da Comissão Europeia denominado "Acesso Seguro e Atempado aos Medicamentos para os Pacientes" (STAMP na sigla em inglês), em colaboração com representantes de organizações sem fins lucrativos, doentes, profissionais de saúde, indústria, avaliação de tecnologias de saúde e pagadores. Read more
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EU: Important Document for Inspections revisedThe EU Commission has published a revision of the "Compilation of Union Procedures on Inspections and Exchange of Information". This is the eighteenth revision. It mainly involves editorial changes, a few adjustments and two new documents. The most fundamental change is the division into two parts. The first part covers and describes the various processes in short sub-documents, the second part contains interpretative documents and templates. Read more
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Regulatory update - EMA encourages companies to submit type I variations for 2021 in November 2021The European Medicines Agency (EMA) is advising marketing authorisation holders to submit type IA and type IAIN variations for 2021 no later than Tuesday 30 November 2021. This will enable EMA to acknowledge the validity of the submissions before the Agency's closure between 23 December 2021 and 3 January 2022 and within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008. Read more
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How to submit informationMarketing-authorisation holders and sponsors of clinical trials are required to submit information on authorised and investigational medicines to the European Medicines Agency (EMA). Read more
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Written GDP Training Programme: What does this mean in Practice?Chapter 2 of the EU GDP Guidlines requires a written training programme. Read more
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EMA inicia avaliação de novo medicamento para a COVID-19A Agência Europeia de Medicamentos (EMA na sigla em inglês), através do seu Comité de Medicamentos de Uso Humano (CHMP na sigla em inglês), iniciou uma avaliação contínua do medicamento antiviral oral molnupiravir (também conhecido como MK 4482 ou Lagevrio) para o tratamento de COVID-19 em adultos. Read more
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New Limits for Heavy Metals in Food SupplementsThe European Commission (EC) sets new limits for Cadmium (Cd) and Lead (Pb) in certain foodstuffs and food supplements. Products placed on the market before the entry into force of the new regulations and not complying with the new maximum levels should only be allowed to remain on the market for a short period of time. Read more
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Change Control for Computerised SystemsChange Control for computerised systems is not a trivial issue. Although the internal requirements for change control are usually in place, the devil is often in the details. Read more
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Implementation of the European Pharmacopoeia Supplement 10.7 – Notification for CEP holdersSupplement 10.7 of the European Pharmacopoeia (Ph. Eur.) is now available. Holders of Certificates of suitability to the monographs of the Ph. Eur. (CEPs) are invited to update their applications according to the revised monographs that will be implemented on 1 April 2022, and to follow the instructions given below. Read more
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First-in-class medicine to treat aggressive form of breast cancerEMA has recommended granting a marketing authorisation in the European Union (EU) for Trodelvy (sacituzumab govitecan), a first-in-class medicine to treat adult patients with unresectable (cannot be removed by surgery) or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for advanced disease. Read more
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EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)EMA’s human medicines committee (CHMP) has started a rolling review of Evusheld (also known as AZD7442), a combination of two monoclonal antibodies (tixagevimab and cilgavimab), which is being developed by AstraZeneca AB for the prevention of COVID-19 in adults. Read more
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New Limits for Heavy Metals in Food SupplementsThe European Commission (EC) sets new limits for Cadmium (Cd) and Lead (Pb) in certain foodstuffs and food supplements. Products placed on the market before the entry into force of the new regulations and not complying with the new maximum levels should only be allowed to remain on the market for a short period of time. Read more
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EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19EMA has started evaluating an application for marketing authorisation for the monoclonal antibody combination Ronapreve (casirivimab / imdevimab). The applicant is Roche Registration GmbH. Read more
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ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic riskThis guideline emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use. Read more
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The ICH M7(R2) draft Guideline and Addendum reaches Step 2 of the ICH processThe ICH M7(R2) draft Guideline and Addendum on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 2 of the ICH process on 6 October 2021 and now enters the public consultation period. Read more
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EU: further Extension of GMP and GDP CertificatesThe EU will extend GMP and GDP certificates until the end of 2022 due to ongoing pandemic restrictions. The relevant document has been updated for this purpose. Read more
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EMA starts review of meningioma risk with nomegestrol- and chlormadinone-containing medicinesEMA has started a review of medicines containing the active substance nomegestrol or chlormadinone. These medicines can be used, alone or in combination with other active substances, to treat gynaecological disorders such as amenorrhea (absence of menstrual periods) and other menstrual disorders, uterine bleeding, endometriosis (a condition in which tissue similar to the lining of the womb grows elsewhere in the body), breast tenderness, and as hormone replacement therapy or contraceptives (birth control). Read more
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Transatlantic Taskforce continues international fight against antimicrobial resistanceThe Transatlantic Taskforce on Antimicrobial Resistance (TATFAR) has enhanced synergy and communication between its member agencies resulting in strengthened domestic and global efforts in the fight against the urgent threat of antimicrobial resistance (AMR). The progress of TATFAR and its achievements in addressing AMR were reviewed at a conference held on 14/15 September, and are summarised in the 2016-2020 progress report. Read more
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Risk of the presence of mutagenic azido impurities in losartan active substanceIn April 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) reported that it had received information about the possible presence of potentially mutagenic azido impurities in certain sartan active substances. Investigations requested by the EDQM indicated that only a few sources were impacted. A number of measures were taken to ensure that any active substance containing these impurities above the acceptable level would not be released onto the market. In addition, any impacted holders of a Certificate of Suitability (CEP) were requested to take corrective action to ensure that such impurities do not exceed their acceptable limits in the future. The EDQM review of these actions in the impacted sources has been completed for some manufacturers and is well advanced for others. Read more
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New General Ph. Eur. Chapter 2.1.7 Balances for Analytical PurposesIn the European Pharmacopoeia (Ph. Eur.) Supplement 10.6, published in July 2021, a new general chapter 2.1.7 Balances for Analytical Purposes was included. It complements existing guidelines for the use and qualification of balances published elsewhere. The scope of the new chapter is limited to balances used for analytical purposes. Balances used for manufacturing and other purposes are not covered. Read more
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EMA evaluating data on booster dose of COVID-19 vaccine SpikevaxEMA has started evaluating an application for the use of a booster dose of Spikevax (Moderna’s COVID-19 vaccine) to be given at least 6 months after the second dose in people aged 12 years and older. Read more
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Good manufacturing practiceGood manufacturing practice (GMP) describes the minimum standard that a medicines manufacturer must meet in their production processes. The European Medicines Agency (EMA) coordinates inspections to verify compliance with these standards and plays a key role in harmonising GMP activities at European Union (EU) level. Read more
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EMA regular press briefing on COVID-19The European Medicines Agency (EMA) is holding a fortnightly press briefing to provide an update on EMA's COVID-19 activities. Read more
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Nova edição do Boletim de FarmacovigilânciaJá está disponível a nova edição do Boletim de Farmacovigilância, Volume 25, n.º 8 de agosto de 2021. Read more
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COVID-19 vaccines and medicines: updates for September 2021Recent information relating to COVID-19 vaccines and medicines that has been published since the August 2021 issue of Drug Safety Update, up to 9 September 2021. Read more
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Consultation on Amendments on Pharmacovigilance ActivitiesA targeted stakeholder consultation on amendments to Commission Implementing Regulation (EU) 520/2012 (IR) on pharmacovigilance activities has been published on the EC website. Comments and proposals received will be published and considered in the work leading to the revision of the IR. Read more
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Deliberação n.º 956/2021Cria no INFARMED, na dependência da Direção de Avaliação de Tecnologias de Saúde, a Unidade de Gestão da Avaliação e Acesso de Medicamentos Read more
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Deliberação n.º 946/2021Alteração do Regulamento das Boas Práticas de distribuição por grosso de medicamentos de uso humano. Read more
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Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/PfizerEMA’s human medicines committee (CHMP) has approved additional manufacturing sites for the production of Comirnaty, the COVID-19 vaccine developed by BioNTech and Pfizer. Read more
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Final EMA Guideline: Quality Requirements for Combination ProductsFollowing a draft version, the EMA has now published the final guideline, which describes what documentation is required on the subject of quality for combination products in order to gain and/or maintain a marketing authorization. Read more
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ICH publishes Guideline Q13 on Continuous ProductionEnd of July, the ICH (International Council for Harmonisation) published the long-awaited draft guideline on continuous manufacturing. The ICH had already announced in June 2018 that it was working on a new ICH Guideline on Continuous Manufacturing with the abbreviation Q13. In addition to batch definitions, the document describes three different continuous manufacturing approaches and provides guidance on control strategy and approval issues. Read more
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Comunicado da Agência Europeia de Medicamentos: avaliação de pedido de utilização de dose de reforço da vacina ComirnatyA Agência Europeia de Medicamentos (EMA na sigla em inglês) começou a avaliar um pedido de utilização de uma dose de reforço da vacina Comirnaty em pessoas com 16 anos ou mais, a ser administrada 6 meses após os cidadãos terem completado o seu processo de vacinação primária. Read more
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ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccinesBased on current evidence, there is no urgent need for the administration of booster doses of vaccines to fully vaccinated individuals in the general population, according to a technical report issued yesterday by the European Centre for Disease Prevention and Control (ECDC). The report also notes that additional doses should already be considered for people with severely weakened immune systems as part of their primary vaccination. Read more
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EMA and FDA update Principles for Parallel Scientific Advice in the Marketing Authorization ProcessScientific advice and recommendations from regulatory authorities are usually of great benefit for specific medicines in the development phase. The principles for this have recently been updated by the U.S. and European regulatory authorities. Read here how parallel scientific advice from the EMA and the FDA works and what benefits it brings to the approval process. Read more
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What is Similarity?The EMA published the final reflection paper on "Similarity". The paper shows how statistics should be used in drug development when a comparative assessment of quality attributes (QAs) needs to be made for pre- and post-manufacturing changes, biosimilar development as well as generics´ development. Read more
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Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and ModernaEMA’s human medicines committee (CHMP) has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. Read more
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FDA Approves First COVID-19 VaccineApproval Signifies Key Achievement for Public Health Read more
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First monoclonal antibody treatment for COVID-19 approved for use in the UKThe Medicines and Healthcare products Regulatory Agency (MHRA) has today given approval for the first monoclonal antibody treatment for the prevention and treatment of COVID-19 in the UK. Read more
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Audit Trail-Deviations in the course of InspectionsKlaus Feuerhelm, former GMP inspector at the Regierungspräsidium Tübingen in Germany, has compiled a TOP 3 list of deficiencies from 2020 in computerised systems. Number 1 are deficiencies with regard to the audit trail. Read more
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EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19EMA has started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to extend its use to include treatment of hospitalised adult patients with severe COVID-19 who are already receiving treatment with corticosteroids and require extra oxygen or mechanical ventilation (breathing assisted by a machine). Read more
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Northern Ireland: EU continues to look for Solutions - with interesting Forms of DocumentsHave you ever heard of a "non-paper"? That is the name given by the EU Commission to a new document that describes proposed solutions for the practical handling of problems within the framework of the Northern Ireland Protocol. The exact title is "Non-Paper: Medicines and the Implementation of the Protocol on Ireland and Northern Ireland"; it was published on 26 July. Read more
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Comunicação conjunta EMA e ECDC sobre COVID-19: EMA e ECDC recomendam vacinação em todos os cidadãos elegíveisNo segundo comunicado conjunto sobre a vacinação contra a COVID-19, a Agência Europeia de Medicamentos (EMA na sigla em inglês) e o Centro Europeu de Prevenção e Controlo das Doenças (ECDC na sigla em inglês) recomendam a vacinação o mais breve possível contra a COVID-19 de toda a população elegível que ainda não foi vacinada ou não tenha completado o esquema vacinal recomendado. Este comunicado surge na sequência do aumento da circulação da variante Delta do SARS-CoV-2 nos países da UE/EEE. Apenas com esquema vacinal recomendado com qualquer vacina autorizada na UE/EEE será possível proteção elevada contra doença grave, morte por SARS-CoV-2 incluindo variantes, como é o caso da variante Delta. A vacinação é igualmente importante para proteger a população com maior risco de doença grave e hospitalização, mas também para reduzir a disseminação do vírus e, como tal, evitar o surgimento de novas variantes de preocupação e de infeções entre aqueles já vacinados. Read more
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Boas Práticas de Distribuição e FarmacovigilânciaForam publicados no Jornal Oficial da União, três atos de execução da CE ao abrigo do Regulamento (UE) 2019/6 do parlamento europeu e do conselho de 11 de dezembro de 2018, relacionados com as Boas Práticas de Distribuição (BPD) e Farmacovigilância. Read more
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Sistema europeu de ensaios clínicos lançado em janeiroA Comissão Europeia (CE) confirmou que a entrada em vigor do Regulamento Europeu de Ensaios Clínicos, bem como o lançamento do Sistema Europeu de Ensaios Clínicos (Clinical Trials Information System - CTIS), acontecerá a 31 de janeiro de 2022, seis meses após publicação no Jornal Oficial da União Europeia. Read more
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Parecer sobre vacinação universal de pessoas entre os 12 e 15 anosA Direção-Geral da Saúde (DGS) solicitou o parecer da Ordem dos Farmacêuticos (OF) sobre a vacinação universal de pessoas entre os 12 e 15 anos contra a COVID-19. Read more
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Novo serviço de alertas de tecnologias de saúdeDesenvolvido no âmbito da medida SIMPLEX Comunica + (medida conjunta Infarmed/ACSS), foi hoje lançado um novo serviço de alertas de tecnologias de saúde (SATS) destinado à disponibilização de informação sobre segurança, qualidade e disponibilidade dos medicamentos. Read more
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Relatório de Farmacovigilância: monitorização da segurança das vacinas contra a COVID-19 em Portugal
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Aviso de indisponibilidade de aplicaçõesInforma-se que, por motivos de manutenção, as aplicações CITS, Infomed, INSP+, SIATS e SMUH poderão apresentar períodos de indisponibilidade durante a manhã de 2ª feira (26/7). Read more
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Updated Templates for Reporting Nitrosamine Contamination to Regulatory AuthoritiesWithin the framework of the referral procedure according to Art. 5(3) of Regulation (EC) 726/2004 ("Call for Review"), marketing authorisation holders of medicinal products containing chemically synthesissed and biological APIs are requested to perform a confirmatory testing of their products for nitrosamine content (step 2) after a risk of contamination with nitrosamines has been identified in a previous assessment of the manufacturing process (step 1) (see our news on the update of the question and answer document on nitrosamine contamination). Read more
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EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failureEMA has started evaluating an application to extend the use of Kineret (anakinra) to include treatment of coronavirus disease 2019 (COVID-19) in adult patients with pneumonia who are at risk of developing severe respiratory failure (inability of the lungs to work properly). Read more
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International regulators work towards alignment on development and authorisation of second-generation COVID-19 vaccinesRegulatory convergence is critical for expediting and streamlining global development and authorisation of new or modified COVID-19 vaccines to address emerging coronavirus variants. The important role of regulatory alignment is described in the summary of the second workshop on COVID-19 vaccine development and virus variants, organised under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), which has been published today. Read more
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EMA and ECDC update on COVID-19Vaccination remains one of the best protective measures against COVID-19. Recommendations for vaccination are in place in all Member States and roll-out of vaccination is ongoing. The European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC) urge EU citizens to get vaccinated and to adhere to the recommended number of doses.1 This is particularly important taking into account the spread of the Delta variant of SARS-CoV-2 (the virus that causes COVID-19), the need to protect citizens, especially those at risk of severe COVID-19, and the desire to open up our societies and relax restrictions. Read more
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Q&A Document on Nitrosamine Impurities UpdatedAt the end of June, the question and answer document of the EMA and the CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human) was updated again and published as 4th revision on the EMA news page on 2 July. The updates affect questions 3 and 10 of the document. Read more
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Comirnaty e Spikevax: possível ligação a casos muito raros de miocardite e pericarditeA miocardite e a pericardite são doenças inflamatórias do coração que se manifestam geralmente por falta de ar, dor no peito e batimento cardíaco intenso que pode ser irregular (palpitações). São doenças que ocorrem com determinada frequência na população em geral e evoluem geralmente de forma benigna. Read more
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Brexit: EU defines possible Solutions for Northern IrelandThe European Commission has published a so-called "balanced package" of measures to address some of the most pressing issues related to the implementation of the Protocol on Ireland and Northern Ireland. With this commitment, the EU tries to find "creative solutions". Read more
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Pharmeuropa 33.3 just releasedAll new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.3 is 30 September 2021. Read more
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Nitrosamine impuritiesThe European Medicines Agency (EMA) has assessed the risk of nitrosamine formation or presence during the manufacture of human medicines and has provided guidance to marketing authorisation holders to avoid the presence of nitrosamine impurities. Read more
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Novo Regulamento dos Dispositivos Médicos: ficha informativa para mandatários, importadores e distribuidoresConsulte a infografia. Read more
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EMA publishes Q&A Document about Parallel DistributionParallel distribution is defined as the distribution of a centrally authorised medicinal product from one Member State to another by a pharmaceutical company independent of the marketing authorisation holder. Centrally authorised products are marketed in all Member States under the same name and must comply with the Community Marketing Authorisation. Read more
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First cell-based gene therapy to treat adult patients with multiple myelomaEMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Abecma (idecabtagene vicleucel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three previous therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since receiving the last treatment. Read more
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Aplicação do Regulamento dos Dispositivos Médicos (RDM) na parte que se refere à investigação clínica de dispositivosO Regulamento Europeu dos Dispositivos Médicos (RDM)1 relativo aos dispositivos médicos tornou-se aplicável a 26 de maio de 2021, revogando as Diretivas 90/385/CEE e 93/42/CEE, sem necessidade de proceder à sua transposição para o ordenamento jurídico nacional. Read more
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Novo Regulamento dos Dispositivos Médicos: ficha informativa para fabricantesConsulte a infografia. Read more
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Novo Regulamento dos Dispositivos Médicos: modelo para a implementação, passo a passoConsulte o guia passo a passo. Read more
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Ph. Eur. General Notices Chapter - New Structure and ContentThe European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of Ph. Eur. chapter 1. General Notices to provide greater clarity for users. Read more
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COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditisEMA’s safety committee (PRAC) is continuing its assessment of reports of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the membrane around the heart) in a small number of people following vaccination with COVID-19 vaccines. Read more
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International regulators and WHO address need to boost COVID-19 vaccine confidenceThe International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) have jointly developed a statement to help healthcare professionals increase trust and confidence in COVID-19 vaccines and answer questions from patients about the development, regulatory review and safety monitoring of these vaccines. Read more
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EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndromeEMA’s COVID-19 taskforce (COVID-ETF) is advising healthcare professionals in the EU to consider recommendations by learned societies when assessing people with signs and symptoms of thrombosis with thrombocytopenia syndrome (TTS) following vaccination with Vaxzevria and COVID-19 Vaccine Janssen. In this context it is highlighting guidance from the International Society on Thrombosis and Haemostasis (ISTH). Read more
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Novo Regulamento dos Dispositivos Médicos: está preparado?Consulte a infografia com o calendário de transição das diretivas. Read more
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The GMP Requirements for Supplier QualificationSupplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements? Read more
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Questions & Answers on Good Distribution Practices (GDP) - Part 4In October 2020, the ECA offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Read more
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First COVID-19 vaccine approved for children aged 12 to 15 in EUEMA’s human medicines committee (CHMP) has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use in children aged 12 to 15. The vaccine is already approved for use in adults and adolescents aged 16 and above. Read more
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Insufficient data on use of inhaled corticosteroids to treat COVID-19EMA’s COVID-19 taskforce (COVID-ETF)1 is advising healthcare professionals that there is currently insufficient evidence that inhaled corticosteroids are beneficial for people with COVID-19. Read more
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Comunicado de Imprensa - Novo Regulamento Europeu dos Dispositivos MédicosO novo Regulamento representa uma atualização significativa das diretivas existentes sobre dispositivos médicos, que estão em vigor há 30 anos. Tem como objetivo fortalecer e melhorar o sistema regulamentardosdispositivos médicos na Europa, de forma a garantir que os dispositivos médicos sejam seguros e funcionem conforme planeado ao longo do seu tempo de vida. Visa também assegurar que a inovação e o desenvolvimento de novas tecnologias são promovidosa nível europeu para proporcionarem aos doentes e aos sistemas de saúde novas opções terapêuticas e de diagnóstico. Read more
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APIC: Update of the Template for Potential Nitrosamine ContaminationsThe latest version of the "REPORT ON THE RISK OF POTENTIAL PRESENCE OF NITROSAMINE IMPURITIES" has been available on the APIC website since April 2021. The questionnaire is to be seen as a summary report and can be used to document the results of risk assessments with regard to contamination by nitrosamines in APIs. It needs to be completed for one API at a time and complies with the applicable requirements for risk assessment in the field of nitrosamines as specified by the regulatory authorities. Read more
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Vaxzevria: Recomendações adicionais relativamente à ocorrência muito rara de coágulos sanguíneos invulgares com diminuição do nível de plaquetas (síndroma de trombose e trombocitopenia, TTS)A Agência Europeia de Medicamentos (EMAna sigla em inglês) efetuou recomendações adicionais relativamente à ocorrência muito rara de formação de coágulos sanguíneos invulgares associados a um nível baixo de plaquetas (trombocitopenia) após vacinação com Vaxzevria (anteriormente denominada vacina contra a COVID-19 da AstraZeneca). Read more
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First gene therapy to treat children with rare inherited neurological diseaseEMA has recommended granting a marketing authorisation in the European Union for the gene therapy Skysona (elivaldogene autotemcel) for the treatment of children with cerebral adrenoleukodystrophy (CALD), a severe form of a rare inherited neurological disease. This disease, seen almost exclusively in males, affects the brain and leads to an irreversible loss of neurological functions. Read more
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EMA procedural advice for medicinal products intended exclusively for markets outside the European Union in the context of co-operation with the World Health Organisation (WHO)
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GMP: Are there "planned" Deviations?One discussion we have again and again in seminars is the question of planned variations. But such terminology can lead to problems. Read more
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Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices
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CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines
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MHRA establishes own GMDP DatabaseEudraGMDP is a GMP and GDP related database of the European Community containing manufacturing and wholesale authorisations, GMP certificates and non-Compliance Reports published in the EudraGMDP database. These reports are generated by the competent authorities, which conduct GMP inspections at the premises and upload their reports into the database. In 2019, Swissmedic has begun to enter information on GMP inspections and manufacturing authorisations for Swiss manufacturers into the database. Read more
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Revised monograph Water for injections published for public comment in PharmeuropaThe revised general monograph Water for injections (0169) has been published in this quarter’s issue of Pharmeuropa (33.2), the European Pharmacopeia (Ph. Eur.) online forum, for comment. The text has been revised to delete the tests for inorganic substances from the section on Sterilised water for injection. Read more
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Vacinas para a COVID-19: Relatório sobre reações adversas em PortugalO Infarmed disponibiliza, desde abril, para consulta no seu site (na área COVID-19/Vacinas), um relatório sobre as reações adversas notificadas às vacinas para a COVID-19. Read more
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International regulators and WHO call for wider public access to clinical dataThe International Coalition of Medicines Regulatory Authorities (ICMRA) and the World Health Organization (WHO) are urging pharmaceutical companies to publish clinical trial reports for new medicines and vaccines without redactions to ensure that research results are publicly accessible to all those involved in healthcare decision-making. In a joint statement, they stress that systematic transparency can increase trust in regulatory decision-making, reassure the public about data integrity and can stimulate research and development, which could have a positive impact on vaccine confidence. Read more
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Revision of the PIC/S Guidelines for ATMPs and Biological Medicinal ProductsEspecially in the field of biological agents and medicinal products and in ATMPs, developments are progressing rapidly. The development of vaccines in the context of the Corona pandemic has clearly shown this. This necessarily also has an impact on the relevant guidelines. Read more
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EMA starts rolling review of COVID-19 Vaccine (Vero Cell) InactivatedEMA’s human medicines committee (CHMP) has started a rolling review of COVID-19 Vaccine (Vero Cell) Inactivated, developed by Sinovac Life Sciences Co., Ltd. The EU applicant for this medicine is Life'On S.r.l. Read more
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EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to include young people aged 12 to 15. Read more
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A new collaboration between SNOMED International and ICH promotes seamless data exchange in support of public healthSNOMED International and ICH are announcing the release of important new maps between global medical terminologies SNOMED CT and MedDRA. Read more
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Unidade de Farmacovigilância de Braga inicia atividadesO Sistema Nacional de Farmacovigilância conta agora com um nova Unidade Regional de Farmacovigilância (URF), em Braga. Esta unidade, que iniciou a sua atividade este mês, está sediada no Hospital de Braga e será responsável pelo tratamento das notificações de Reação Adversas a Medicamentos (RAM) ocorridas nos distritos de Vila Real, Bragança e nos concelhos de Amares, Barcelos, Braga, Vieira do Minho, Vila Verde, Esposende, Póvoa de Lanhoso, Terras de Bouro e Vila Nova de Famalicão, pertencentes ao distrito de Braga, correspondendo a uma população de cerca de 912mil pessoas e mais de 4000 profissionais de saúde. Read more
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Questions & Answers on Good Distribution Practices (GDP) - Part 3In October 2020, the ECA offered the Live Online Training "The GDP Compliance Manager". During the Q&A sessions, many interesting questions were posed to the speakers' team. The ECA would like to share a selection of these Q&As sorted by topic. Read more
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Banco Farmacêutico apela à doação de medicamentosRealiza-se dia 24 de abril, a XIII Jornada de Recolha de Medicamentos organizada anualmente pelo Banco Farmacêutico. Mais de 150 farmácias em todo o país vão apelar à doação de medicamentos não sujeitos a receita médica e outros produtos de saúde destinados a utentes de mais de 120 instituições particulares de solidariedade social. A pandemia de COVID-19 impede a participação de centenas de voluntários na jornada deste ano, mas a organização espera também que impulsione a generosidade dos portugueses para apoiar as populações mais carenciadas num período particularmente difícil. Read more
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COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood plateletsAt its meeting of 20 April 2021, EMA’s safety committee (PRAC) concluded that a warning about unusual blood clots with low blood platelets should be added to the product information for COVID-19 Vaccine Janssen. PRAC also concluded that these events should be listed as very rare side effects of the vaccine. Read more
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The Draft Principles of ICH E6 Good Clinical Practice (GCP) now availableThe ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients. Acknowledging the wide and substantial impact of ICH E6, the ICH Management Committee is making available a draft, work-in-progress version of the updated principles that are currently under development by the ICH E6(R3) Expert Working Group (EWG). The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliable results of clinical trials. Read more
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EMA starts review of VIR-7831 for treating patients with COVID-19EMA is reviewing currently available data on the use of the monoclonal antibody VIR-7831 (also known as GSK4182136) in the treatment of patients with COVID-19. EMA is starting this review to support national authorities who may decide on the use of this medicine for COVID-19 prior to marketing authorisation. Read more
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COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continuesAs announced last week, EMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots that occurred in the United States following the use of Janssen’s COVID-19 vaccine. The type of blood clot reported, cerebral venous sinus thrombosis (CVST), occurred in most cases in combination with low levels of blood platelets (thrombocytopenia). Read more
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Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia
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Pharmeuropa 33.2 just releasedAll new European Pharmacopoeia (Ph. Eur.) texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 33.2 is 30 June 2021. Read more
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AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood plateletsEMA’s safety committee (PRAC) has concluded today that unusual blood clots with low blood platelets should be listed as very rare side effects of Vaxzevria (formerly COVID-19 Vaccine AstraZeneca). Read more
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EMA: Revision of Q&A Documents regarding the Centralised ProcedureAgain, two of the Q&A documents relating to the "centralised procedure" have been updated and published on the website of the European Medicines Agency (EMA) in March 2021. The documents are the "European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure" and the "European Medicines Agency post-authorisation procedural advice for users of the centralised procedure", which refer to pre-authorisation as well as post-authorisation questions. The latest versions of these two sets of questions have each been supplemented by a question regarding the importation of finished medicinal products into the European Union. Read more
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AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continuesEMA’s safety committee (PRAC) is meeting today, Wednesday 31 March, in the context of its ongoing review of very rare cases of unusual blood clots associated with low numbers of platelets, in people vaccinated with AstraZeneca’s COVID-19 vaccine (now called Vaxzevria). Read more
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Rapid Revision and Implementation of Pharmacopoeial Monographs Concerning 5 Sartan PreparationsFollowing the publication of the Assessment Report "Nitrosamine impurities in human medicinal products" by the CHMP on 9 July 2020, the decision was made to directly apply the recommendations on the management of nitrosamine impurities outlined in this report to sartan preparations (angiotensin II receptor antagonists with a tetrazole ring). Read more
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Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and ModernaEMA’s human medicines committee (CHMP) has adopted several important recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. Read more
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COVID-19 Vaccine AstraZeneca – Update on ongoing evaluation of blood clot casesLast week, EMA’s safety committee, PRAC, concluded its preliminary review of cases of blood clots, including very rare cases of blood clots with unusual features such as low numbers of platelets, in people vaccinated with COVID-19 Vaccine AstraZeneca. The committee confirmed that the vaccine is not associated with an increase in the overall risk of blood clots and that the benefits of the vaccine in combating the still widespread threat of COVID-19 continue to outweigh the risk of side effects. The committee recommended including more information and advice for healthcare professionals and the public in the vaccine’s product information. Read more
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Brexit: Pharmacovigilance Requirements for UK MAHsFollowing the Brexit, the MHRA posted an updated guidance to become familiar with the pharmacovigilance requirements for UK marketing authorization holders (MAHs). Read more
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EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trialsEMA has reviewed the latest evidence on the use of ivermectin for the prevention and treatment of COVID-19 and concluded that the available data do not support its use for COVID-19 outside well-designed clinical trials. Read more
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COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood plateletsEMA’s safety committee, PRAC, concluded its preliminary review of a signal of blood clots in people vaccinated with COVID-19 Vaccine AstraZeneca at its extraordinary meeting of 18 March 2021. Read more
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Investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events continuesEMA’s safety committee (PRAC) made further progress today, Tuesday 16 March, in its detailed evaluation of cases of blood clots, some with unusual features such as low numbers of platelets, in recipients of COVID-19 Vaccine AstraZeneca. As previously stated, while its investigation is ongoing, EMA currently remains of the view that the benefits of the AstraZeneca vaccine in preventing COVID-19, with its associated risk of hospitalisation and death, outweigh the risks of side effects. Read more
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EMA’s safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further updateSeveral authorities responsible for national vaccine campaigns in EU countries have temporarily paused vaccination with COVID-19 Vaccine AstraZeneca. This is a precaution taken in the light of their national situation while EMA investigates a number of events of blood clots in people who had received the vaccine, as previously reported. Read more
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Esclarecimento da Direção-Geral da Saúde e do INFARMED, I.P. face à ação das autoridades dinamarquesas, norueguesas e islandesas de suspender temporariamente a vacinação com a vacina contra a COVID-19 da AstraZenecaA decisão, por parte das autoridades dinamarquesas, norueguesas e islandesas de suspensão temporária da vacinação com a vacina da AstraZeneca foi uma medida de precaução. Não foi confirmado que os eventos tromboembólicos notificados tenham sido causados por esta vacina. As pessoas podem ser vacinadas de acordo com o agendamento efetuado. Read more
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Vacina contra a COVID-19 AstraZeneca: resultados preliminares não sugerem problema específico com o lote usado na ÁustriaNa sequência da informação relativa à suspensão, pela Autoridade Competente Austríaca, da utilização do lote ABV5300 da vacina contra a COVID-19 da AstraZeneca (ver Nota Informativa de 07/03/2021), o Comité de Avaliação do Risco em Farmacovigilância (PRAC) da Agência Europeia de Medicamento (EMA na sigla em inglês) encontra-se a avaliar os casos de eventos tromboembólicos notificados que ocorreram após administração desta vacina. A informação disponível, até ao momento, indica que o número de eventos tromboembólicos em pessoas vacinadas não é superior ao observado na população em geral. Read more
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CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines
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Suspensão da AIM de medicamentos contendo ranitidinaConforme divulgado na Circular informativa n.º 143/CD/550.20.001 de 20/09/2019 e na Circular informativa nº 171/CD/550.20.001 de 08/11/2020, o Infarmed recomendou a recolha e suspensão imediata da comercialização dos lotes de medicamentos com ranitidina. Read more
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Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
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EMA starts rolling review of the Sputnik V COVID-19 vaccineEMA’s human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine1 developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. The EU applicant for this medicine is R-Pharm Germany GmbH. Read more
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EMA Guidance on Adjusting Vaccines to COVID-19 VariantsCurrently, the increasing emergence of new SARS-CoV2 variants is presenting new challenges to medicine, health authorities and also vaccine manufacturers. On 22 February, the FDA, as the relevant US-American authority, published a series of appropriately amended guidance documents containing recommendations for the developers and manufacturers of COVID-19 vaccines. Read more
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First oral treatment for spinal muscular atrophy (SMA) recommended for approvalEMA has recommended granting a marketing authorisation in the European Union for the first treatment that can be given orally to patients with certain types of spinal muscular atrophy (SMA), a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement. Read more
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International cooperation to align approaches for regulation of COVID-19 vaccines and medicinesRegulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate the development, authorisation and monitoring of safe, effective and high-quality vaccines and medicines against COVID-19. This was highlighted in a series of regulatory workshops, convened under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) in the first weeks of 2021, which focused on three areas: responding to emerging COVID-19 virus variants, addressing knowledge gaps regarding COVID-19 vaccines and treatments in pregnant and breastfeeding women, and strengthening collaboration on safety monitoring of vaccines. Read more
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EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known as CT-P59), which is being developed by Celltrion, for the treatment of COVID-19. Read more
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Brexit: Pharmacovigilance Requirements for UK MAHsFollowing the Brexit, the MHRA posted an updated guidance to become familiar with the pharmacovigilance requirements for UK marketing authorization holders (MAHs). Read more
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EMA starts evaluating use of Veklury in COVID-19 patients not requiring supplemental oxygenEMA has started evaluating an application to extend the use of Veklury (remdesivir) to include treating adults with COVID-19 who do not require supplemental oxygen. Read more
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European Medicines Regulatory Network approach for the implementation of the CHMP Opinion pursuant to Article 5(3) of Regulation (EC) No 726/2004 for nitrosamine impurities in human medicines
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Brexit Guideline from CMDh updatedThe Heads of Medicines Agencies (HMA) consists of the heads of the National Competent (EU) Authorities who are responsible for the regulation of medicinal products in the EU. The Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) of the HMA has updated a recently published Guideline on Brexit. Read more
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Modern Vaccines and Platform Technologies - Explained in an Understandable WayIn the current situation, we receive a variety of questions about the current vaccine development, vaccine types, licensure and more. Read more
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EMA starts rolling review of Novavax’s COVID-19 vaccine (NVX-CoV2373)EMA’s human medicines committee (CHMP) has started a rolling review of NVX-CoV2373, a COVID 19 vaccine being developed by Novavax CZ AS (a subsidiary of Novavax, Inc.). Read more
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New EU Commission Brexit Notice on Medicinal ProductsThe EU Commission published a new notice in the Official Journal of the EU on 25 January 2021 entitled "Application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through Great Britain after the end of the transition period 2021/C 27/08)". Read more
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EMA starts rolling review of REGN-COV2 antibody combination (casirivimab / imdevimab)EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a medicine known as REGN-COV2 antibody combination (casirivimab / imdevimab), which is being co-developed by Regeneron Pharmaceuticals, Inc. and F. Hoffman-La Roche, Ltd (Roche) for the treatment and prevention of COVID-19. Read more
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EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EUEMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age. This is the third COVID-19 vaccine that EMA has recommended for authorisation. Read more
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First COVID-19 vaccine safety update publishedToday EMA has released its first safety update on a COVID-19 vaccine — Comirnaty. It concludes that safety data collected on Comirnaty use in vaccination campaigns is consistent with the known safety profile of the vaccine, and no new side effects were identified. Read more
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Rastreabilidade de stocks de medicamentos para COVID-19Em sequência das circulares informativas do Infarmed n.º 062/CD/100.20.200, de 05/03/2020, e n.º 068/CD/100.20.200, de 13/03/2020, sobre o assunto em epígrafe, o Infarmed vem recordar da importância para a monitorização rigorosa dos stocks dos medicamentos incluídos no Despacho n.º 8057/2020, de 19 de agosto, o qual estabelece o reforço de stocks de medicamentos e diversos equipamentos médicos e da reserva estratégica nacional, no âmbito da pandemia COVID-19. Read more
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COVID-19 and vaccines: Equitable access to vaccination must be ensuredHow can we ensure equitable access to vaccination during the current and future pandemics? The Council of Europe Committee on Bioethics has made today a number of recommendations. Read more
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Public-health advice during COVID-19 pandemicThe European Medicines Agency (EMA) is providing impartial advice to patients and healthcare professionals on the safe use of medicines during the COVID-19 pandemic, in particular in patients with or at risk of COVID-19 infection. Read more
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Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccinesEMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) to inform and help healthcare professionals answer questions about the evaluation, approval and monitoring of safe, effective and high-quality COVID-19 vaccines. Read more
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National competent authorities (human)The European Medicines Agency works closely with the national competent authorities of the Member States of the European Union (EU) and the European Economic Area (EEA) responsible for human medicines. Read more
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Brexit Agreement - what now?After intensive negotiations, the European Union (EU) and the United Kingdom (UK) agreed on a provisional Trade and Cooperation Agreement on 24 December 2020. By the end of the year, all remaining EU member states have given their consent to the agreement and its provisional application. For the agreement to finally enter into force, the approval of the European Parliament is still required. Read more
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EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZenecaEMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine, known as COVID-19 Vaccine AstraZeneca, will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by 29 January during the meeting of EMA’s scientific committee for human medicines (CHMP), provided that the data submitted on the quality, safety and efficacy of the vaccine are sufficiently robust and complete and that any additional information required to complete the assessment is promptly submitted. Read more
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Extra dose from vials of Comirnaty COVID-19 vaccineEMA’s human medicines committee (CHMP) has recommended updating the PDF iconproduct information for Comirnaty to clarify that each vial contains 6 doses of the vaccine. Read more
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EMA recommends COVID-19 Vaccine Moderna for authorisation in the EUEMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine Moderna to prevent Coronavirus disease (COVID-19) in people from 18 years of age. This is the second COVID-19 vaccine that EMA has recommended for authorisation. Read more
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Brexit: the United Kingdom's withdrawal from the European UnionThe United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. During a transition period from 1 February to 31 December 2020, EU pharmaceutical law continued to apply to the UK. From 1 January 2021, EU pharmaceutical law applies to the UK in respect of Northern Ireland only. Read more
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EMA organises a second public meeting about the new COVID-19 vaccinesEMA will organise a second public meeting on 8 January 2021 to inform European citizens about the assessment, approval and roll-out of new COVID-19 vaccines. Read more
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European Commission authorises first safe and effective vaccine against COVID-19
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EMA Management Board: highlights of December 2020 meetingThe December 2020 meeting of the Management Board was Emer Cooke’s first Board meeting as EMA's Executive Director since she took up leadership of EMA in November. Read more
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Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccineOver the last few weeks, EMA has made good progress on the assessment of the marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine. A continuous dialogue with the company has ensured that questions that arose during the evaluation were swiftly followed up and addressed by the company. Read more
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Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation applicationEMA’s human medicines committee (CHMP) and its experts have been working intensively over the past weeks to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation (CMA) application for BNT162b2, a COVID 19 mRNA vaccine. Read more
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Comissão Europeia disponibiliza Q&A sobre vacinas COVID-19A Comissão Europeia publicou no seu site uma área de Perguntas e Respostas sobre o processo de autorização condicional de introdução no mercado das vacinas COVID-19. Read more
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COVID-19 vaccines: studies for approvalThe European Medicines Agency (EMA) needs many detailed studies to confirm that a vaccine is safe, provides adequate protection and is of suitable quality. As a public-health body safeguarding medicines in the European Union (EU), EMA will only approve a vaccine for COVID-19 after a thorough evalutation demonstrating the same high standards of quality, safety and efficacy required for any other vaccine approved in the EU. Read more
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infoDM em vídeo: nova ferramenta de pesquisa pública de dispositivos médicosJá conhece a nova ferramenta de pesquisa pública dos dispositivos médicos registados no Infarmed? Através dela poderá saber quais os dispositivos médicos disponíveis no mercado e as suas caraterísticas. Read more
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Estratégia conjunta prepara futuro da rede de agências reguladoras de medicamentos da UE até 2025Como uma das agências que fazem parte desta rede de excelência, o Infarmed comunica que a Agência Europeia de Medicamentos (EMA, na sigla em inglês) e os Chefes das Agências de Medicamentos (HMA, na sigla em inglês) publicaram a sua estratégia conjunta para os próximos cinco anos. Read more
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EMA publica orientações sobre flexibilização quanto à informação do medicamento (Folheto Informativo e Rotulagem) para as vacinas contra a COVID-19No âmbito das medidas de flexibilidade quanto à rotulagem e embalagem das vacinas contra a COVID-19, o Infarmed informa que a Agência Europeia de Medicamentos (EMA na sigla em inglês) publicou o documento Questions and answers on labelling flexibilities for COVID19 vaccines , com orientações sobre a forma como poderá ser agilizado o desenvolvimento das vacinas no que diz respeito à informação do medicamento nomeadamente Folheto Informativo e Rotulagem, permitindo uma distribuição rápida e em larga escala na União Europeia. Read more
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Coronavirus: Commission presents “Staying safe from COVID-19 during winter” strategy
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EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2EMA has received an application for conditional marketing authorisation (CMA) for BNT162b2, a COVID 19 mRNA vaccine developed by BioNTech and Pfizer. The assessment of BNT162b2 will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued within weeks, depending on whether the data submitted are sufficiently robust and complete to show the quality, safety and effectiveness of the vaccine. Read more
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EMA - Public Meeting on COVID-19 VaccinesNo other topic is currently as controversial as the research, approval and production of vaccines for COVID-19. The discussion about the necessity, side effects of vaccinations, etc. has been going on for a long time. Due to the accelerated procedures in relation with the Corona pandemic and the uncertainty in the population, these discussions, fueled by a large number of comments and articles in the social media and demonstrations by opponents of the vaccination, have greatly increased. Read more
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Update on remdesivir - EMA will evaluate new data from Solidarity trialEMA is aware that the World Health Organization (WHO) has updated its guidelines advising against the use of remdesivir in hospitalised patients with COVID-19, regardless of disease severity based on a recent meta-analysis. Read more
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EMA publica documento sobre critérios de desenvolvimento e avaliação clínica das vacinas contra a COVID-19No âmbito da avaliação das vacinas contra a COVID-19, e tendo em conta a necessidade de atualização face aos mais recentes desenvolvimentos nesta área, o Infarmed vem pelo presente comunicar que a Agência Europeia de Medicamentos (EMA na sigla em inglês), publicou o documento "EMA considerations on Covid-19 vaccine approval", onde são apresentados os critérios base aplicáveis ao desenvolvimento e avaliação dos dados clínicos para aprovação das vacinas contra a COVID-19. Read more
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Coronavirus: Commission steps up actions on testing with a recommendation on rapid antigen tests and support to increase testing capacity
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Antimicrobial resistanceThe emerging and steady increase of microbes that are resistant to antimicrobial treatments has become a global public health concern that threatens the effective treatment of infectious diseases. Combatting this threat, particularly resistance to antibiotics, is a high priority for the European Medicines Agency (EMA) and the European medicines regulatory network. Read more
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EMA starts rolling review of mRNA COVID-19 vaccine by Moderna Biotech Spain, S.L.EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.). Read more
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Nitrosamines: EMA aligns recommendations for sartans with those for other medicinesEMA’s human medicines committee (CHMP) has aligned recommendations for limiting nitrosamine impurities in sartan medicines with recent recommendations it issued for other classes of medicines. Read more
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COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLsThe European Directorate for the Quality of Medicines & HealthCare (EDQM) has published three new Official Control Authority Batch Release (OCABR) guidelines outlining the tests to be performed by Official Medicines Control Laboratories (OMCLs) in the EU OCABR Network as part of the independent control of pandemic COVID-19 vaccine batches. They were adopted by the full OCABR Network and are in force from 12 November 2020. Read more
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Consulte a nova infografia sobre o SIDMSistema de Informação para Dispositivos Médicos (SIDM), desenvolvido no âmbito do programa SIMPLEX, foi lançado a 2 de novembro de 2020. Read more
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Novo Sistema de Informação para Dispositivos Médicos (SIDM): assista ao vídeoO Novo Sistema de Informação para Dispositivos Médicos (SIDM), que foi lançado no 2 de novembro, apresenta-se agora em vídeo onde se podem ver destacadas as suas principais funcionalidades e o que de novo este sistema de informação oferece aos seus utilizadores. Read more
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Novo sistema de informação para dispositivos médicosO Infarmed desenvolveu um novo Sistema de Informação para Dispositivos Médicos (SIDM) para facilitar e promover o registo de dispositivos médicos pelos operadores e aumentar a transparência do processo, tornando pública toda a informação de registo residente na autoridade reguladora. Read more
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Labelling and Packaging Flexibilities for Covid-19 VaccinesThe European Commission (EC) recently published labelling and packaging flexibilities for COVID-19 vaccines. According to the EC, "flexibility in the labelling and packaging requirements can facilitate the rapid deployment of the vaccine by increasing production capacity, reducing transport costs and storage space, and improving the distribution of the doses between Member States". Read more
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Extra transparency measures for COVID-19 vaccines and therapeuticsThe European Medicines Agency (EMA) has implemented two further extra transparency measures for COVID-19 medicines, by publishing both the clinical data in support of the authorisation of Veklury (remdesivir) and information on the COVID-19 treatments and vaccines that have received scientific advice or informal guidance from EMA’s pandemic Task Force (COVID-ETF). Read more
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PRAC recommendations on safety signalsEach month, the European Medicines Agency publishes an overview listing all safety signals discussed during the latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting and the recommendations given for each of them. The overview includes PRAC recommendations for centrally and nationally authorised medicines. Read more
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Strengthening global collaboration on COVID-19 real-world evidence and observational studies
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EMA starts second rolling review of a COVID-19 vaccineEMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a vaccine for COVID-19 known as BNT162b2, which is being developed by BioNTech in collaboration with Pfizer. Read more
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EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccinesThe European Medicines Agency (EMA) has re-affirmed today that it will uphold its long-standing commitment to independence and transparency in its evaluation of COVID-19 treatments and vaccines. Read more
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EMA starts first rolling review of a COVID-19 vaccine in the EUEMA’s human medicines committee (CHMP) has started the first ‘rolling review’ of a COVID-19 vaccine, which is being developed by the company AstraZeneca in collaboration with the University of Oxford. Read more
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Nota Informativa para profissionais de saúde e doentes - Novo tratamento para a COVID-19: EMA recomenda a utilização de dexametasona nos doentes com COVID-19 que requerem terapia com oxigénioO INFARMED, I.P. informa que o Comité de Medicamentos para Uso Humano (CHMP) da Agência Europeia de Medicamentos (EMA na sigla em inglês) concluiu recentemente a revisão dos resultados do estudo RECOVERY, que envolveu especificamente o uso do medicamento dexametasona, no tratamento de doentes com COVID-19 internados e no hospital, e emitiu um parecer favorável a 18/09/2020 em que considera a dexametasona uma opção de tratamento para os doentes que necessitam de suporte ventilatório (desde a administração suplementar de oxigénio até à ventilação mecânica). Read more
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Drug Shortages: a European Solution at Last?The European Parliament's Committee on the Environment, Public Health and Food Safety had prepared a "Report on the Shortage of Medicines - how to address an emerging Problem", which has now been adopted by the European Parliament. The aim is to make the European Union regain its independence with regard to healthcare. Read more
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PRAC recommendations on safety signalsEach month, the European Medicines Agency publishes an overview listing all safety signals discussed during the latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting and the recommendations given for each of them. The overview includes PRAC recommendations for centrally and nationally authorised medicines. Read more
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EFPIA statement on the European Regulatory Network Strategy to 2025EFPIA welcomes the European medicines regulatory agencies network (EMRN) draft strategy to 2025 (EUNS 2025) and fully supports the establishment of an overarching strategic plan. EFPIA views the EUNS 2025 and the related EMA’s Regulatory Science Strategy to 2025 (RSS 2025) as essential to bringing the promising next wave of innovation to patients who live with the burden of unmet medical need. Read more
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AstraZeneca Resumes Phase 3 COVID-19 Vaccine Trial in UKAstraZeneca announced on Saturday that it has resumed its phase 3 COVID-19 vaccine trial in the UK after pausing it last Tuesday due to a single “unexplained illness.” Read more
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Comunicado de Imprensa - Suspensão momentânea de vacina para COVID-19De acordo com a informação pública, o laboratório farmacêutico AstraZeneca suspendeu momentaneamente os ensaios clínicos que decorrem a nível mundial para avaliar a segurança e a eficácia da sua vacina para a COVID-19. Read more
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Brexit: How to import Medicines into UKThe UK Medicines and Healthcare Products Regulatory Agency (MHRA) has just published a Guidance for Wholesaling and Importing Activities after the end of the Transition Period. Read more
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Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021Pharmacovigilance system requirements from 1 January 2021 Read more
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EU: Checklist for Brexit PreparationThe European Commission has published a 'Brexit Readiness Checklist' for companies doing business with the UK. Read more
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PIC/S publishes Q&A document on Health Based Exposure Limits and Cross-ContaminationIn the last newsletter you could already read about a new Aide-Memoire of the PIC/S for the inspection of health-based exposure limits (HBEL). At the same time, the PIC/S has published a Q&A document on HBEL and cross-contamination. What is behind this Q&A paper? Read more
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GDP Monograph for Active Substances: Interactive PDF now availableIn June 2020, the "Good Distribution Practice for Active Substances Guidance on interpretation and implementation" has been published as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute. The monograph is based on the text of the European Commission "Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)", but is applicable to all sectors of the distribution network worldwide. It will be of benefit to all involved in active substance distribution activities for initial training, continuing professional development and as a reference source or audit tool. Read more
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Coronavirus: Commission approves funding for training of healthcare professionals in intensive care skills
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Can the Application of Safety Features be outsourced?The European Commission has published a new version of the "Questions & Answers regarding the implementation of the rule on safety features for medicinal products for human use" - now the 18th version. Read more
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Nitrosamines risk assessment: update for CEP holdersIn October 2019, the EDQM requested companies holding CEPs to perform a risk assessment of their chemically synthesised APIs with regards a potential nitrosamines formation, using quality risk management principles. It was highlighted that the factors to be taken into account were outlined in the dedicated Questions and Answers documents available on the EMA and CMDh websites. Read more
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Estratégia da Rede de Agências Europeias de Medicamentos em consulta públicaA Agência Europeia do Medicamento (EMA) e os chefes das agências nacionais de medicamentos nos países europeus desenvolveram uma estratégia conjunta para os próximos cinco anos, que se encontra disponível para consulta pública até 4 de setembro. Read more
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Evaluation of the medicines for rare diseases and children legislationOn 11 August 2020, the European Commission published its evaluation (main document – part 1, annexes: part 2, part 3, part 4, part 5, part 6) on the legislation for medicines for rare diseases and for children. An executive summarySearch for available translations of the preceding link••• in English, French and German is also available. Read more
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INFORMATION ON NITROSAMINES FOR MARKETING AUTHORISATION HOLDERSCMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines Read more
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The E2B(R3) User Guide v1.1 Available Now on the ICH WebsiteThe v1.1. of the User Guide of EDQM terminologies for Dose Forms and Routes of Administration for Individual Case Safety Reports in E2B(R3) message (i.e. E2B(R3) User Guide v1.1) reached Step 4 of the ICH process in July 2020. Read more
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FIP atualiza relatório sobre vacinação nas farmáciasA Federação Internacional Farmacêutica (FIP) publicou um novo relatório sobre o impacto e contributo dos farmacêuticos para a cobertura vacinal, com o título “An overview of pharmacy’s impact on immunisation coverage: a global survey". Read more
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Brexit: Sponsors Need to Establish an EU-QPSince 1 February 2020, the UK has withdrawn from the EU. The transition period ends on 31 December 2020. Since no extension was requested as of July 1 2020, there is no possibility for further extension beyond that date. Read more
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The ICH S11 introductory training presentation available now on the ICH websiteThe ICH S11 Guideline on Nonclinical Safety Testing in Support of Development of Paediatric Pharmaceuticals reached Step 4 of the ICH Process in April 2020. Read more
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Leuprorelin-containing depot medicinal products.Leuprorelin , Daronda,Depo-Eligard,Eligard,Eligard Depot,Eligard Mensua,Eligard Semestral,Eligard Trimestral,Elityran 1 Month Depot (Dps),Elityran 3 Month Depot (Dps),Enanton Depot Dual,Enanton Depot Set,Enantone,Enantone L.P,Enantone Lp,Enantone Monats-Depot,Ginecrin Depot,Klebrocid 3-Monats-Depot,Klebrocid Depot Zweikammerspritze,Leptoprol,Lerin,Leugon,Leuprex 3,Leuprol,Leuprolin Ratiopharm,Leuprone 1-Monatsdepot,Leuprone 3-Monatsdepot,Leuprorelin 1-Month Depot Gp-Pharm,Leuprorelin Hexal,Leuprorelin Sandoz,Leuprorelina Gp-Pharm,Leupro-Sandoz 1-Monats-Depot,Leupro-Sandoz 3-Monats-Depot,Leuprorelina Trimestral Sandoz,Leuprostin,Leuproreline Sandoz,Lucrin,Lucrin Depot,Lucrin Pds Depot,Lucrin Pds Depot 1 Maand,Lucrin Pds Depot 3 Maanden,Lucrin Pds Depot 6 Maanden,Lupron Depo,Lutrate 1 Month Depot,Lutrate 3 Month Depot,Lutrate Depo,Lutrate Depot,Lutrate Depot Trimestral,Politrate,Politrate Politrate Depot,Procren Depot,Procren Depot Pds,Procrin Mensual,Procrin Semestral,Procrin Trimestral,Prostap 3 Dcs,Prostap 6 Dcs,Prostap Sr Dcs,Prostaplant,Sixantone,Trenantone,Trenantone-Gyn,Zeulide,Елигард,Лутрат Депо, Article 31 referrals, CMDh final position, 24/06/2020, 31/07/2020 Read more
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UK Group Receives CE Mark for COVID-19 Rapid Antibody TestUK diagnostics company Abingdon Health has received a CE Mark for a COVID-19 antibody test that delivers results in 20 minutes. Read more
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Guidance for medicine developers and companies on COVID-19The European Medicines Agency (EMA) is providing guidance for medicine developers and pharmaceutical companies to help speed up medicine and vaccine development and approval for COVID-19, and on how they should address the regulatory challenges arising from the COVID-19 pandemic. Read more
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EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory supportEMA is reviewing results from the RECOVERY study arm that involved the use of dexamethasone in the treatment of patients with COVID-19 admitted to hospital. This part of the study looked into the effects of adding dexamethasone to usual care in adults receiving invasive ventilation, those given oxygen (e.g. through a mask) or those receiving no oxygen. Invasive ventilation involves use of a machine to push air through a tube inserted into the patient’s airway. Read more
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CHMP's Assessment Report on Nitrosamines publishedOn 9 July 2020, the final report on nitrosamine contamination was published on the EMA website. This final statement of the CHMP entitled "Assessment report - Nitrosamine impurities in human medicinal products" EMA/369136/2020 represents the end of the procedure under Article 5(3) of Regulation 726/2004, which started on 10 September 2019. The 90-page document contains the current state of science and knowledge regarding nitrosamine impurities in human medicinal products and provides recommendations for manufacturers of medicinal products based on chemically defined APIs and biological medicinal products. Read more
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Pharmacovigilance Audits and Inspections during COVID-19The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document is updated continuously and includes Q&As relating to pharmacovigilance. Read more
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Covid-19: Handling of Marketing AuthorisationsThe processes and procedures relating to marketing authorisations are still strongly influenced by the corona pandemic. On the website of the HMA (Heads of Medicines Agencies) this has been reiterated and the available templates and information to facilitate and manage marketing authorisations and registration procedures have been consolidated and listed. Read more
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Regulatory Authorities worldwide work more closely together because of COVID-19The Swiss authority Swissmedic announced on its website that regulatory authorities around the world will work more closely together due to Covid-19. Three areas have been identified for this: research during pregnancy, medicinal products from clinical trials and monitoring of vaccines in terms of safety and efficacy. Read more
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Infarmed e restantes agências de medicamentos europeias juntas no combate à COVID-19Os Chefes das Agências do Medicamento Europeias (Heads of Medicines Agencies) estão a promover uma iniciativa de comunicação, a nível da União Europeia, para melhor dar a conhecer aos cidadãos europeus o trabalho conjunto das várias agências de medicamentos europeias no combate à COVID-19. Read more
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EMA finalises opinion on presence of nitrosamines in medicinesEMA’s human medicines committee (CHMP) has issued an opinion requiring companies to take measures to limit the presence of nitrosamines in human medicines as far as possible and to ensure levels of these impurities do not exceed set limits. Read more
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Distant Assessment leads to GMP Non-Compliance ReportMany GMP inspectorates have started performing remote inspections for selected sites for the duration of the outbreak of Covid-19. In the EU for example, the European Commission, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have agreed a series of measures to mitigate the impact of disruptions caused by COVID-19 on the conduct of inspections of manufacturing facilities or other sites relevant for medicinal products in the EU. In an Q&A document, it is stated that for new sites/facilities, a "distant assessment" conducted by an EU/EEA competent authority may be an option. A GMP certificate may be then "granted depending on the outcome of the assessment". Read more
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Is an Update of the QPPV´s Contact Details a Variation?The Co-ordination Groups for Mutual Recognition and Decentralized Procedures (CMDh and CMDv) recently published a revised version of the Q&A paper regarding variations. Read more
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Impact of COVID-19 on EudraVigilance Reporting and LabelingThe European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) released a Q&A document on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic. The document includes flexible approaches for adverse reactions reporting and labeling. Read more
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New GDP Monograph for Active Substances publishedThe Good Distribution Practice for Active Substances Guidance on interpretation and implementation has been published as a joint publication of the ECA Foundation's GDP Association and the Pharmaceutical Quality Group of the Chartered Quality Institute. The monograph is based on the text of the European Commission "Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01)", but is applicable to all sectors of the distribution network worldwide. Read more
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First COVID-19 treatment recommended for EU authorisationEMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. Read more
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Recommendations on medication errorsIn the European Union (EU), national competent authorities and the European Medicines Agency (EMA) play a key role in identifying and reducing the risk of medication errors before and after the authorisation of a medicine. EMA applies a consistent approach to communicating to patients and healthcare professionals on any additional measures recommended by the Agency to reduce the risk of medication errors with a specific medicine. Read more
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Nitrosamine impuritiesIn 2018, nitrosamine impurities, including N-nitrosodimethylamine (NDMA), were found in a number of blood pressure medicines known as 'sartans'. This led to some product recalls and to a regulatory review, which set strict new manufacturing requirements for these medicines. Subsequently, a nitrosamine impurity has been detected in batches of ranitidine, a medicine used to treat heartburn and stomach ulcers, and the Agency's Committee for Medicinal Products for Human Use (CHMP) has started a review. Read more
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European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicinesSenior officials from the European Commission (EC - DG SANTE), EMA and the United States Food and Drug Administration (FDA) held their 2020 bilateral regulatory dialogue meeting on 18 and 19 June. During this virtual two-day meeting, the authorities reviewed their ongoing joint initiatives, discussed strategic priorities for the coming years and identified areas where their already close collaboration can be further strengthened. Read more
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CEPs: What Applicants and Authorisation Holders should know!Due to the current situation in Europe, many applicants and marketing authorisation holders (MAHs) are increasingly asking how and to what extent "CEPs" (Certificate of Suitability of Monographs of the European Pharmacopoeia) are currently being processed and issued. Read more
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International regulators stress value of safe and effective vaccinesEMA has endorsed two statements about the importance, safety and effectiveness of vaccines published today by the International Coalition of Medicines Regulatory Authorities (ICMRA). International regulators from around the world have come together and jointly developed these statements for healthcare professionals and the general public to give assurance that the regulatory processes for the authorisation and safety monitoring of vaccines are robust, independent and focus firmly on public health. Read more
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Remote GCP InspectionsThe European Medicines Agency (EMA) released a new guidance explaining how remote Good Clinical Practice (GCP) inspections should be conducted during the COVID-19 pandemic. Read more
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Follow-up activities after Pharmacovigilance InspectionsEMA´s Pharmacovigilance Inspectors Working Group adopted a new guideline on the follow-up activities of pharmacovigilance inspections (effective since May 1, 2020). It applies to the follow-up of pharmacovigilance inspections of Marketing Authorization Holders (MAHs) with centrally authorized products (CAPs), nationally authorized products (NAPs), products authorized via the mutual recognition or decentralized procedure (MRP, DCP). The new guideline replaces the EMA document “Union procedure on the management of pharmacovigilance inspection findings which may impact the robustness of the benefit-risk profile of the concerned medicinal products”. Read more
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EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in EuropeThe EDQM is committed to supporting vaccine developers during the coronavirus disease (COVID-19) pandemic – as well as contributing to the wider global effort to combat the virus – by openly sharing knowledge and offering temporary free access to relevant guidance and standards. Read more
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EU Member States report illegal and ineffective disinfectantsSeveral EU countries have signalled to ECHA and the European Commission that the COVID-19 pandemic has led to an increased number of non-compliant (hand) disinfectants on the market. National enforcement authorities are taking action to protect citizens from the risks of illicit and ineffective products. Read more
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Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis
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Derogation for Process Validation due to Covid-19Europe is taking exceptional steps to ensure that the population continues to receive high quality, effective and safe medicinal products during the Covid-19 pandemic. A Questions & Answers document has been prepared in cooperation between the European Commission, the Coordination Group for Mutual Recognition and Decentralised Procedures (CMDh), the "Inspectors Working Group" and the European Medicines Agency (EMA) - please also see "COVID-19: Update of the Q&A document - Validity of GDP Certificates and Wholesale Authorisations". At the end of May, special features for process validation (question 6.2) were added under the heading "GMP Flexibilites". Read more
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COVID-19: reminder of the risks of chloroquine and hydroxychloroquineEMA is reminding healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine, given the serious side effects that can result from treatment with these medicines. Read more
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European medicines regulatory network fully mobilised in fight against COVID-19The development and availability of medicines and vaccines for all patients in the European Union, including those with COVID-19, is the number one priority for the European medicines regulatory network. EMA, together with EU Member States and the European Commission, has published a PDF iconplan outlining principles for how the network will ensure that core public and animal health regulatory activities, such as the authorisation, maintenance and supervision of human and veterinary medicines will continue to be carried out during the ongoing COVID-19 pandemic. Read more
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Prospective dialogue between developers and regulators makes for better evidence generationEMA, in collaboration with other parties, has recently published two scientific articles outlining the importance of early interactions as an opportunity to improve the generation of evidence required for bringing innovation to patients. Read more
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EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccinesEMA is engaging early with researchers to ensure that a European infrastructure will be in place to effectively monitor COVID-19 vaccines in the real world, once these are authorised in the European Union. The Agency has signed a contract with Utrecht University as coordinator of the EU Pharmacoepidemiology and Pharmacovigilance Research Network, a public-academic partnership of 22 European research centres, to conduct preparatory research into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice. The ACCESS (vACcine Covid-19 monitoring readinESS) project will be led by the University Medical Center Utrecht (UMCU) and Utrecht University. Read more
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Resposta à COVID-19 aprovada em Assembleia Mundial da SaúdeA 73.ª Assembleia Mundial da Saúde, da Organização Mundial da Saúde (OMS), reunida por teleconferência, aprovou por consenso, no passado dia 19 de maio, uma resolução, promovida pela União Europeia, intitulada “Resposta à COVID-19”. Read more
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Global regulators commit to cooperate on observational research in the context of COVID-19Regulators from around the world have agreed three priority areas for cooperation on observational research during COVID-19. They will collaborate on pregnancy research, on medicines used in clinical practice and on vaccine safety and effectiveness monitoring. Read more
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What Marketing Authorisation Holders need to know now about their RegistrationsOn 10 April 2020, the European Medicines Agency (EMA) together with the Heads of Medicines Agencies (HMA) and the European Commission (EC) published a first version of the document "QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC", which is continuously updated and adapted. Read more
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Update of EU recommendations for 2020/2021 seasonal flu vaccine compositionEMA has issued an update of the EU recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2020. Read more
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Máscaras: normas aplicáveis e tipologiaCom o início da fase de desconfinamento, o INFARMED, I.P. tem vindo a ser questionado sobre a tipologia de máscaras e a sua utilização. Read more
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USP´s Quality Considerations for Medical CannabisAuthors from the USP Cannabis Expert Panel recently published an article entitled "Cannabis Inflorescence for Medical Purposes: USP Considerations for Quality Attributes". The paper was published on April 13, 2020 in the Journal of Natural Products (J. Nat. Prod. 2020, 83, 1334-1351). So far neither a USP Monograph on Cannabis nor a Ph. Eur. Monograph is available. However, there are some national Monographs for Cannabis Flower and Cannabis Extract, for example in the German Pharmacopoeia (Deutsches Arzneibuch, DAB). Read more
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EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilationEMA’s human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir so that more patients with severe COVID 19 can be treated. Read more
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Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19In a high-level meeting on COVID-19 policies, organised by EMA under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators from around the world discussed strategic issues and regulatory approaches to ensure a coordinated response to the pandemic. They stressed the need for alignment on pre- and post-authorisation regulatory requirements to facilitate the rapid development, evaluation and availability of medicines for the treatment and prevention of coronavirus disease. Read more
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Infarmed lança infografias alertando para a importância da notificação de reações adversas em doentes com COVID-19O Infarmed, no seguimento de uma ação de informação promovida pela Agência Europeia do Medicamento (EMA na sigla inglesa) à qual se associa, produziu duas infografias – uma dirigida aos cidadãos e outra aos profissionais de saúde – com o objetivo de alertar os doentes com doença COVID-19 (confirmada ou suspeita) e os profissionais que os acompanham, para a importância de notificar qualquer suspeita de reação adversa a medicamentos (RAM), estejam eles a ser ministrados no âmbito da COVID-19 ou sejam de toma habitual. Read more
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EMA starts rolling review of remdesivir for COVID-19EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on the use of the investigational antiviral medicine remdesivir for the treatment of coronavirus disease (COVID-19). Read more
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New EU/EMA planned Actions in the Context of the COVID-19 PandemicThe European Medicines Agency EMA has published three press releases on current EU/EMA activities in the context of the COVID-19 pandemic. Read more
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Guidance for medicine developers and companies on COVID-19The European Medicines Agency (EMA) is providing guidance for medicine developers and pharmaceutical companies to help speed up medicine and vaccine development and approval for COVID-19, and on how they should address the regulatory challenges arising from the COVID-19 pandemic. Read more
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Avaliação da presença de nitrosaminas - Adiamento do prazo para submissão e perguntas frequentesConforme divulgado nas páginas eletrónicas da Agência Europeia do Medicamento (EMA na sigla inglesa) e do Grupo de Coordenação CMDh (Coordination group for Mutual Recognition and Decentralised procedure, human), o prazo para a submissão do risco da presença de nitrosaminas (etapa 1) foi prolongado até ao dia 1 de outubro 2020. Read more
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EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicinesAs part of its health threat plan activated to fight COVID-19, the Agency has finalised and published the PDF iconcomposition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF), which assists Member States and the European Commission in dealing with development, authorisation and safety monitoring of therapeutics and vaccines intended for treatment or prevention of COVID-19. Read more
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Nova edição da newsletter com resumo da informação da área COVID-19Está disponível nova edição da newsletter com o resumo da informação mais recentemente publicada na área COVID-19. Read more
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Ph. Eur. launches a public consultation on a new general chapter for the analysis of N-NitrosaminesThe European Pharmacopoeia (Ph. Eur.) seeks feedback on its new general chapter on the analysis of N-nitrosamine impurities in active substances (2.4.36). Read more
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EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemicThe continued availability of medicines, in particular those used for patients with COVID-19, is of critical concern for EMA and its partners in the European medicines regulatory network in light of the medical emergency presented by the pandemic. Read more
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Commission postpones application of the Medical Devices Regulation to prioritise the fight against coronavirus
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Informação às entidades fabricantes e de distribuição de medicamentos gases medicinais e de dispositivos médicos (COVID-19)A Agência Europeia do Medicamento (EMA na sigla inglesa) e demais parceiros na rede europeia de regulação de medicamentos, incluindo o INFARMED, I.P., encontram-se a monitorizar detalhadamente o potencial impacto da pandemia da doença causada pelo coronavírus (COVID-19) no fornecimento de medicamentos gases medicinais e de dispositivos médicos. Read more
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Regulatory guidance for medical devicesCheck the legal requirements you need to meet before you can place a medical device on the market and see how MHRA monitors compliance. Read more
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Information package for certificates of medicinal products issued by the European Medicines Agency
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Deadline extension to all CEP holders to complete step 1 Risk Assessments regarding presence of nitrosamines (now 31st July 2020)The EDQM recognises that due to the impact of the global outbreak of COVID-19, many CEP holders are encountering significant challenges in completing the work within the timelines previously announced in the EDQM request to CEP holders to perform a risk evaluation of their chemically synthesised APIs with regards nitrosamine formation, published on the EDQM Website (EDQM request October 2019). Read more
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EU GMP Annex 21 finally publishedOn 20 March, after some delays, the new Annex 21 to the EU-GMP Guidelines was published as a draft. The document is entitled "Importation of medicinal Products". The "Concept Paper" was already published on 13 May 2015 (EMA/238299/2015) and the consultation phase ended in August 2015. The first draft for regulatory consultation was published in November 2016. Since then, no further activities or versions have been issued. Read more
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Código de Conduta nos circuitos de distribuição e venda de produtos fitofarmacêuticosA DGAV republica o Código de conduta nos circuitos de distribuição e venda de produtos fitofarmacêuticos na sua edição de 2019, revista e actualizada face à Lei n.º 26/2013 de 11 de abril. Esta reedição contou com a colaboração e revisão crítica de diferentes entidades públicas e privadas de áreas de competência relevantes para os conteúdos do Código e visa o apoio de todos aqueles que, na sua actividade profissional, manuseiam, distribuem e comercializam produtos fitofarmacêuticos de utilização profissional. Read more
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Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemicThe European Commission, the European Medicines Agency (EMA) and national Head of Medicines Agencies (HMA) have published new recommendations for sponsors on how to manage the conduct of clinical trials in the context of the coronavirus disease (COVID-19) pandemic. The impact of the pandemic on European health systems and more broadly on society, will make it necessary for sponsors to adjust how they manage clinical trials and the people who participate in these trials. Read more
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Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure
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Notice to stakeholders ´Withdrawal of the United Kingdom and EU rules for medicinal products for human and veterinary use"
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CMDh Guidance Document on the Numbering System for the Procedures for Mutual Recognition and Decentralised
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Rastreabilidade de stocks de medicamentos para COVID-19 - formato de reporteNa sequência da circular informativa n.º 062/CD/100.20.200 de 05/03/2020, o INFARMED, I.P. divulga por meio desta circular o formato de reporte da informação a disponibilizar relativamente ao stock disponível nas suas instalações dos medicamentos constantes da referida circular, as aquisições e vendas semanais e identificando as entidades destinatárias dos mesmos. Read more
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Corrigendum to Commission Regulation (EU) 2019/1966 of 27 November 2019 amending and correcting Annexes II, III and V to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products ( OJ L 307, 28.11.2019 )
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Questions and answers (version 17) - Safety features for medicinal products for human use
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CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines
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Update on nitrosamines in EU medicinesEU and national authorities are continuing their work to prevent and manage the presence of nitrosamine impurities in EU medicines. Read more
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Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products: Annex I – contact details of national competent authorities (NCAs) for PSUR submission
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Medicines: apply for a parallel import licenceHow to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application. Read more
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QbD for TDS: FDA´s new draft guidanceThe FDA published a draft guideline "Transdermal and Topical Delivery Systems - Product Development and Quality Considerations". Read more
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Draft Annex 1: New Requirements for Lyophilization?Will the revised Annex 1 introduce new GMP requirements for lyophilized products? Read more
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FDA Revises Guidance on Electronic Drug SubmissionsThe FDA issued a final guidance on online submissions for certain drug product applications, clarifying that some submission types are exempt or may qualify for a waiver. Read more
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Second joint targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the PIC/S – EU GMP Guide
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ICH S5(R3) reaches Step 4 of the ICH ProcessThe ICH S5(R3) Guideline on Detection of Toxicity to Reproductions for Human Pharmaceuticals reached Step 4 of the ICH Process in February 2020. Read more
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Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products
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Post-Brexit UK to Overhaul Medical Device AuthorityThe new legislation would empower the health department to impose monetary penalties as an alternative to criminal prosecution. Read more
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FDA Guidance Seeks to Speed Reviews of Biosimilars for Fewer Conditions of UseAs part of its ongoing efforts to encourage biosimilars, the FDA issued draft guidance on the agency’s abbreviated review pathway for sponsors of biosimilars with more limited conditions of use than the reference product. Read more
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Formulário eletrónico para avaliação da presença de nitrosamina em medicamentoConforme descrito na Circular Informativa n.º 145/CD/100.20.200 de 27/09/2019, os titulares de Autorização de Introdução no Mercado (TAIM), como medida de precaução, têm de efetuar a revisão dos medicamentos que contêm substâncias ativas sintetizadas quimicamente para verificar a presença de nitrosaminas e testar todos os medicamentos com potencial risco, reportando, em ambos os casos, os resultados às autoridades nacionais competentes. Read more
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New GMP Guidance for Marketing Authorisation HoldersAfter long discussions, the European Medicines Agency EMA has published a Reflection Paper on Good Manufacturing Practice and Marketing Authorisation Holders (EMA/457570/2019). Read more
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UK Offers Grace Period for Sudden Notified Body WithdrawalsSome devicemakers will be allowed to continue placing their products on the EU market while they deal with the unexpected withdrawal of a notified body, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) said. Read more
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UK Waves Goodbye to EU as Transition Period BeginsThe UK finally departed from the European Union on January 31, beginning a transition period in which EU drug regulations will still apply in the UK. Read more
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Quality of medicines questions and answers: Part 1These questions and answers address a number of questions that have been brought to the attention of the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have been developed and are maintained by the QWP. Read more
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EMA to support development of vaccines and treatments for novel coronavirusTo contribute to the global response to the outbreak of the novel coronavirus (2019-nCoV) infections, EMA is taking concrete actions to accelerate the development and availability of medicinal products for the treatment and prevention of the new coronavirus. Read more
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La AEMPS publica una guía para el envío de información sobre nitrosaminas por parte de los Titulares de Autorizaciones de Comercialización (TAC)La guía tiene como objetivo potenciar la evaluación, por parte de los TAC, del riesgo de la presencia de nitrosaminas en todos los medicamentos de uso humano de síntesis química. Read more
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UK withdrawal from the EU on 31 January 2020The United Kingdom will formally leave the European Union on 31 January 2020 and will become a third country to the EU. On 1 February 2020 a transition period will start which is due to end on 31 December 2020. Read more
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Falta de medicamentos agrava-se na EuropaO Grupo Farmacêutico da União Europeia (PGEU) está a acompanhar o fenómeno de escassez de medicamentos em vários países europeus. Read more
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Report on public consultation on the 'Electronic product information for human medicines in the European Union - draft key principles'
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SCCS - Read the new factsheet: "The SCCS Guidance on the safety assessment of nanomaterials in cosmetics"
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FDA Announces Plan for Electronic Orphan Drug Designation SubmissionsThe FDA plans to allow sponsors to submit orphan drug designation requests electronically later this year. Read more
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Produtos fitofarmacêuticos - Classificação harmonizada de substâncias ativasA DGAV informa que foi publicado o Regulamento de execução (UE) 2020/103 da Comissão de 17 de janeiro de 2020 que altera o Regulamento de Execução (UE) n.º 844/2012 no que diz respeito à classificação harmonizada de substâncias ativas. Este diploma visa o alinhamento do processo de submissão e avaliação da proposta de classificação harmonizada da substância ativa à Agência Europeia dos Produtos Químicos com o processo de avaliação para efeitos de decisão relativa à renovação da aprovação das substâncias ativas, em conformidade com o que se encontra previsto no artigo 36.º, n.º 2, do Regulamento (CE) n.º 1272/2008 do Parlamento Europeu e do Conselho. Read more
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European Medicines Agency’s privacy statement for the EMA Account Management system
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Procedural advice for orphan medicinal product designation: Guidance for sponsors
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Detailed guide regarding the EudraVigilance data management activities by the European Medicines Agency
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MedTech Europe Renews Alarm Over MDR TransitionTime is running out for devicemakers to meet the May 26 deadline to renew or extend their device certificates under the new EU Medical Devices Regulation, MedTech Europe stressed in its latest status report. Read more
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EMA/CHMP publishes new Q&A Document on Comparability Considerations for ATMPsThe EMA/CHMP offers assistance and support in the form of the Scientific Advice to the developing or approving company or institution for the development and approval of drugs. Read more
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Announcement of the EMA Management Board - Confirmation of the mandatory use of the ISO Individual Case Report standard based on ICH E2B(R3) modalities and related ISO standard terminology
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Disponível webservice para notificação de faltas de medicamentosConforme previsto no Regulamento de Gestão da Disponibilidade do Medicamento, o webservice para comunicação automática das faltas de medicamentos está disponível. Read more
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Ranitidine Can Generate NDMA Under Storage Conditions, Lab SaysRanitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Read more
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Orientações europeias dirigidas a fabricantes de dispositivos médicos da classe INo passado dia 18 de dezembro de 2019 foi publicado, pela Comissão Europeia, o documento "MDCG 2019-15 Guidance notes for manufacturers of Class I medical device" relativo às orientações dirigidas a fabricantes para a colocação no mercado de dispositivos médicos de classe I. Read more
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Pharmeuropa 32.1 just releasedAll new texts and texts that have undergone technical revisions are published in Pharmeuropa for public consultation. The deadline for comments on Pharmeuropa 32.1 is 31 March 2020. Read more
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Ranitidine Can Generate NDMA Under Storage Conditions, Lab SaysRanitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Read more
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Canada Releases Final Guidance on Software as a Medical DeviceHealth Canada has finalized guidance on software as a medical device (SaMD) that clarifies how it fits into the agency’s regulatory framework and how devicemakers can comply. Read more
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New symbols for medical device label now available on the ISO websiteIn May this year, MedTech Europe published a guidance on symbols recommended to be used on medical device labels for MDR compliance before the revision of ISO standard 15223-1 is completed. Read more
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ISO Issues Risk Management Standard for DevicesThe International Organization for Standardization (ISO) has released a standard for device manufacturers for assessing and controlling potential medical device hazards. Read more
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Revisão Anual de Preços - 2020Revisão Anual de Preços de Medicamentos Genéricos e Não Genéricos_2020 Read more
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Trump Administration takes historic steps to lower U.S. prescription drug pricesPresident Trump, along with the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration, issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow for the importation of certain prescription drugs from Canada. In addition, the Administration is announcing the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country. Read more
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4-year overview of pharmacovigilance activities in the EU shows robust and effective medicines safety systemA report on the activities ensuring the safety of medicines carried out by EMA and the national competent authorities of the European Union (EU) Member States, Norway and Iceland from 2015 to 2018 shows that the EU pharmacovigilance system is strong and adaptable and has had a positive impact on public health. Read more
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
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Apply for a licence to market a medicine in the UKHow to license a medicine for sale in the UK and Europe, including applications through national, centralised and decentralised procedures. Read more
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VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version
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Outcome of the 165th European Pharmacopoeia CommissionDuring its 165th session, held in Strasbourg on 26 and 27 November 2019, the European Pharmacopoeia (Ph. Eur.) Commission (re)appointed more than 850 experts to its current 21 groups of experts and 39 active working parties for a new term running from November 2019 to November 2022. Read more
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Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with chapter P.III on pharmacovigilance for the use of medicines by pregnant and breastfeeding women
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EMA update on metformin diabetes medicinesEMA is aware that trace amounts of an impurity, N-nitrosodimethylamine (NDMA), have been found in a small number of metformin diabetes medicines outside the EU. Read more
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Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.The U.S. Food and Drug Administration has been investigating the presence of genotoxic impurities, called nitrosamines, in some types of drugs. Over the past year and a half, several drug products including angiotensin II receptor blockers (ARBs) and ranitidine, commonly known as Zantac, have been found to contain small amounts of nitrosamines such as N-Nitrosodimethylamine (NDMA). During this time, there has been an ongoing investigation into the presence of nitrosamines in other drug products. This effort is focused on ensuring the drugs used by Americans continue to meet strict quality standards. Read more
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FDA Issues Guidance on Transdermal and Topical Drug Delivery SystemsThe FDA outlined its current thinking on the information sponsors of transdermal and topical delivery systems (TDS) should include in their NDAs and ANDAs in draft guidance. Read more
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European authorities working to avoid shortages of medicines due to Brexit – Questions and answers
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ICH Q12 adoptedThe International Council for Harmonization (ICH) met in Singapore from 16 – 20 November 2019. The key milestone reached was the adoption of the new ICH Q12 Guideline (Step 4 of the ICH process) on the Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. The new ICH Q12 Guideline including two Annexes is complementary to ICH Quality Guidelines Q8 to Q11. According to ICH, it aims to "promote innovation and continual improvement in the pharmaceutical sector, and strengthen quality assurance and reliable supply of product, including proactive planning of global supply chain adjustments". Read more
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 Novemver 2019At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety update reports and post-authorisation safety studies. Read more
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Questions and answers on “Information on nitrosamines for marketing authorisation holders”
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La AEMPS establece un plazo de adecuación del etiquetado y las instrucciones de uso de Productos Sanitarios como consecuencia de los cambios realizados por un posible brexitA principios de abril, la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) informó, a través de la nota informativa PS, 8/2019, sobre las cuestiones más relevantes relativas a los productos sanitarios, en el caso de que a partir de la fecha del brexit, el Reino Unido pase a considerarse un tercer país, sin que se haya llegado a un acuerdo con la Unión Europea (UE27). Read more
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Final Guideline on CCP for ATMPs publishedIn the recent past, ATMPs have increasingly moved from research and development to clinical trial phases or to the status of approved medicinal product. As a result, this product group has increasingly moved into the focus of regulatory authorities and GMP inspectors. In the near past, you could therefore read about regulatory developments on several occasions, both in the USA and in Europe, for example through the Stakeholder Consultation on the Draft Guideline GCP for ATMP. The results of the consultation are also available on the website of the European Commission. Read more
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Falsified Medicines: New EU Aide Memoire for GDPThe European Commission has published an aide memoire for Good Distribution Practices (GDP) inspection of wholesalers’ compliance with Commission Delegated Regulation (EU) 2016/161 for safety features. The six-page document has been available online since 18 November 2019. Read more
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Novo portal e novo protocolo de cedência de informaçãoA cedência da base de dados de medicamentos e dispositivos médicos e outros produtos comparticipados passará, a partir de hoje, a ser processada através do portal CITS: Cedência de Informação de Tecnologias de Saúde. Read more
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Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use
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Nitrosamines in Elastomers?An USP Stimuli article on Elastomeric Components for Inhalation Packaging / Delivery Systems has been published in Pharmacopeial Forum, proposing to test for nitrosamines in elastomeric components used for inhalation products. Read more
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Commission report on the national and European Medicines Agency experience regarding the list of medicines for human use subject to additional monitoring
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Companies need to improve communication of hazardous substances in productsA Forum pilot enforcement project in 15 participating countries has found that 12 % of inspected products contain substances of very high concern (SVHCs). The majority (88 %) of suppliers of these products are failing to communicate sufficient information to their customers about SVHCs in products they supply. Read more
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FDA Suggests Alternative NDMA Test for Ranitidine
The FDA is recommending a
second low-temperature test for determining if ranitidine products contain the
probable carcinogen N-nitrosodimethylamine (NDMA).
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Revisão da lista de medicamentos abrangidos pela notificação prévia de exportação ou distribuição para outros Estados-membros
Circular Informativa n.º 174/CD/100.20.200, de
11/11/2019 - Foi publicada a Deliberação n.º 095/CD/2019, de 11 de novembro,
que veio atualizar a lista de medicamentos cuja exportação ou distribuição para
outros Estados-membros da União Europeia carece de prévia notificação ao
Infarmed.
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FDA works on regulatory pathways for CBD products
Cannabidiol (CBD) is
currently marketed in a variety of product types, such as oil drops, infused
pouches, capsules, syrups, teas and topical lotions and creams. Therefore, the
FDA is working on the evaluation of regulatory policies related to cannabis and
cannabis-derived ingredients.
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Recolha de lotes de medicamentos contendo ranitidina - Aditamento
Circular Informativa n.º 171/CD - Na sequência da recolha e
suspensão imediata da comercialização de vários lotes de medicamentos contendo
Ranitidina, devido à deteção de uma impureza, N-Nitrosodimethylamine (NDMA), na
substância ativa ranitidina, divulgada através da Circular Informativa N.º
143/CD/550.20.001, de 20/09/2019, foi recebida informação adicional, referente
à decisão de suspensão do Certificado de Conformidade (CEP) R1-CEP 2007-320-Rev
02/Ranitidine hydrochloride Crystalline powder grade and D. C. grade do
fabricante ORCHEV PHARMA PRIVATE LIMITED pelo European Directorate for the
Quality of Medicines & Healthcare (EDQM), pelo que importa atualizar
(informação a negrito) a lista de lotes de medicamentos alvo de recolha.
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Novo alvo terapêutico pode abrir caminho para uma vacina universal contra a gripe
Uma equipa de investigadores publicou um estudo que
defende que uma mudança nos alvos terapêuticos pode criar a primeira vacina
universal contra a gripe. O estudo publicado recentemente na revista The Lancet
Infectious Diseases virou as atenções para uma proteína presente na superfície
do vírus responsável por "orientar" o vírus para as células a infetar.
A nova abordagem permitiu ativar com sucesso os anticorpos responsáveis pelo
combate à gripe em ensaios clínicos de fase I, um resultado que os
investigadores consideram ser promissor.
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Publicado "Regulamento de gestão da disponibilidade do medicamento"
O Regulamento de gestão da disponibilidade do
medicamento foi aprovado - através da Deliberação N.º 93/CD/20019 que o anexa -
e encontra-se já disponível na área Gestão da disponibilidade do medicamento.
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General requirements for Plastics in Pharmaceutical Engineering
The main material used in
plant engineering is stainless steel. The variant 316L is regarded as standard;
material incompatibilities of steel with the product play almost no role. This
is different for plastics. Beside the leach-out, ageing and surface finishing,
other quality features are often specified. Now, what are the general
requirements for plastics in pharmaceutical plant engineering?
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Updated annexes to the eSubmission roadmap published
The following updated
Annexes to the eSubmission Roadmap have been published to reflect current
status of the practical implementation steps. Annex 2 to the HMA eSubmission
Roadmap on the Mandatory use of eCTD for all procedure types and Annex 3 to the
HMA eSubmission Roadmap on the implementation of mandatory VNeeS format for Veterinary
regulatory submissions.
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EU Delays Implementation of Eudamed Until May 2022
The Commission said it will only be
possible to make Eudamed operational when the system is fully functional and
has been independently audited.
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MHRA Issues Brexit Guidance on Comparator Products for Generics
Applicants may be able to
compare their proposed medicine with a non-UK sourced comparator product, the
agency said.
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Announcement to all CEP holders for synthesised APIs regarding presence of nitrosamines
EMA and CMDh have published
documents on their websites, (EMA/189634/2019 and CMDh/404/2019), “Information
on nitrosamines for marketing authorisation holders” which request marketing
authorisation holders (MAH) to follow an investigation process described for
synthesised APIs (other than sartans with a tetrazole ring). Although EDQM does
not expect that this issue impacts many substances, it is now appropriate to
expand the review to all other APIs manufactured from chemical synthesis for
which CEPs have been granted.
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PRAC recommendations on signals adopted at the 30 September-3 October 2019 PRAC meeting
Read more
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CMDh practical guidance for Marketing Authorisation Holders of nationally authorised products (incl. MRP/DCP) in relation to the Art. 5(3) Referral on Nitrosamines
Read more
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Questions and answers on implementation of the medical devices and in vitro diagnostic medical devices Regulations ((EU) 2017/745 and (EU) 2017/746)
Read more
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019
Read more
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Atualização da lista de grupos homogéneos e preços de referência
No âmbito do Sistema de Preços de Referência, a lista dos grupos
homogéneos e dos preços de referência unitários, a vigorar no 4.º trimestre de
2019, foi atualizada.
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Ph. Eur. 2.4.20. Determination of elemental impurities
A complete revision of Ph.
Eur. chapter 2.4.20. Determination of elemental impurities has been
published in Pharmeuropa.
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Produtos Fitofarmacêuticos - Indicadores de Risco Harmonizados
Foi publicada a Diretiva (UE) 2019/782 de 15 de maio
que estabelece Indicadores de Risco Harmonizados com vista a medir os
progressos realizados na redução dos riscos e dos efeitos negativos da utilização
de pesticidas na saúde humana e no ambiente, tal como previsto na Diretiva (CE)
n.º 2009/128/CE, do Parlamento Europeu e do Conselho, de 21 de outubro de 2009,
relativa ao uso sustentável dos pesticidas.
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Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 October 2019
Read more
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MHRA Will Require ‘UK Responsible Person’ for All Devices, IVDs
The UK responsible person
must ensure that an appropriate conformity assessment procedure has been
carried out by the manufacturer.
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Essential maintenance to computer applications on Wednesday 09-10-2019
PSUR and eSubmissions Web User Interface
(to create the delivery file) will be unavailable between 07:00-09:00hrs (CEST)
on Wednesday, 9 October 2019. However, the EMA gateway will remain available
for all communities throughout and any files submitted during that time will be
queued for processing when the work is complete. If you have any questions,
please contact the IT Service Desk.
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Registo de entidades no RNEC
O Registo Nacional de Estudos Clínicos (RNEC) constitui uma plataforma eletrónica para registo e divulgação de estudos clínicos a decorrer em Portugal. Desta forma, o público em geral, os profissionais de saúde e investigadores terão acesso a informação sobre os ensaios clínicos com medicamentos de uso humano a decorrer em Portugal. Este desígnio só será possível com o envolvimento e contributo de todas as entidades que participam em ensaios clínicos.
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FDA Cautions on Use of ‘Bayesian’ Statistics in Complex Trials
Using Bayesian methods “can
increase the chance of erroneous conclusions,” the agency says.
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EMA website on Permitted Daily Exposure (PDE) limits
The issue of
cross-contamination has been addressed by authorities since the publication of
the first edition of the EU GMP Guidelines. The EMA has compiled everything
essential on health-based exposure limits and PDE limits on their website.
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FDA publishes Q&A on Internal Standard Responses in Chromatography Bioanalysis
In support of sponsors,
applicants and research institutions, the FDA examines in more detail the
variability of internal standards in analytics and their consequences. The
authority has now published a document entitled "Evaluation of Internal
Standard Responses During Chromatographic Bioanalysis: Questions and
Answers".
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Avaliação da presença de nitrosamina em medicamentos
Circular Informativa Nº. 145/CD/100.20.200 de
27/09/2019 - No sentido de fornecer informação aos TAIM sobre as ações que eles
devem executar, estão disponíveis no site da Agência Europeia dos medicamentos
(EMA na sigla inglesa) e no site do Grupo de Coordenação para os procedimentos
de reconhecimento mútuo e descentralizado, CMDh, documentos orientadores que
devem ser seguidos.
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EDQM updates two Guidelines on the CEP procedure
The updating of two important documents
by the EDQM reflects the current practice of the CEP procedure. Read more about
the competencies and responsibilities of the various bodies in the CEP
application procedure and about the code of practice for assessors and
inspectors.
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Focused stakeholders consultation on revised draft PIC/S GMP Guide Annex 2A (Manufacture of Advanced Therapy Medicinal Products for Human Use) and Annex 2B (Manufacture of Biological Medicinal Substances and Products for Human Use)
A draft revision of the PIC/S GMP Guide
Annex 2 (Manufacture of biological medicinal substances and products for human
use) has been prepared by the PIC/S Working Group on revision of Annex 2
established with WHO, led by Francesco Cicirello, Australia / TGA, and by the
PIC/S Sub-Committee on GMDP Harmonisation, led by Paul Gustafson, Health
Canada.
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How to draft a direct healthcare professional communication
Guidance for marketing
authorisation holders on drafting direct healthcare professional communications
(DHPCs) or 'dear Dr letters', including the template.
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Biological medicine quality to receive major boost
The Medicines and Healthcare
products Regulatory Agency have released a Strategy for Pharmacopoeial Public
Quality Standards for Biological Medicines update.
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Aprovada lista dos grupos homogéneos e dos preços de referência unitários - 4.º trimestre de 2019
A lista dos Grupos Homogéneos e dos preços de
referência unitários a vigorar no 4.º trimestre de 2019 foi aprovada.
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Novo regulamento para gerir disponibilidade de medicamentos em Consulta Pública
O Infarmed colocou em Consulta Pública um novo projeto de
regulamento para gerir a disponibilidade de medicamentos, um documento que vem
definir as regras e procedimentos para notificação de faltas ou ruturas de
medicamentos, bem como as obrigações dos titulares de autorizações de
introdução no mercado, dos distribuidores grossistas e farmácias.
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The ICH E17 Guideline training materials available now on the ICH website
The ICH E17 Guideline on
General Principles for Planning and Design of Multi-Regional Clinical Trials
was finalised under Step 4 in November 2017. This Guideline provides guidance
on general principles on planning/designing Multi-Regional Clinical Trial
(MRCT).
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Track & Trace: Still ongoing issues
It has hardly worked out anywhere: the
falsification protection project has not been properly adapted EU-wide and
discontentment is spreading amongst pharmacists.
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Final version of the Guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction or have endocrine-disrupting properties
Read more
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FDA Offers Advice on Benefit-Risk Considerations for Device Submissions
“The continuous, robust
generation of evidence throughout the premarket and postmarket setting … is
important to continuously refine our understanding of how medical devices are
used and perform,” the agency said.
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Amazon vende milhares de produtos inseguros ou proibidos
De acordo com uma investigação recente, a Amazon está a vender
pelo menos 4.152 produtos que foram incorretamente identificados, proibidos ou
declarados como inseguros pelas autoridades nacionais.
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Orchestra BioMed Receives CE Mark for Implantable Hypertension Treatment
The principal investigator said the device has
potential as a primary treatment for hypertension.
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EMA publishes first two Guidances on Drug Shortages
The European Medicines Agency (EMA) and
the Heads of Medicines Agencies (HMA) published two guidance documents which
can be seen as foundation for a long way to diminish shortages of medicinal
products.
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PhRMA Applauds FDA’s New Review Template for New Drug, Biologic Applications
PhRMA said it “strongly
encourages” the FDA’s new “integrated review process,” which combines
assessments by the agency’s different disciplines into a single document for
new drug applications and efficacy supplements.
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Global public meeting on draft ICH guideline on clinical trials
The ICH E8 guideline sets
out general scientific principles for the conduct, performance and control of
clinical trials. In recent years, clinical trials have undergone a radical
transformation with a wider range of both trial designs and data sources being
used in drug development. Therefore, ICH initiated a revision of the E8
guideline to address all the aspects that were not covered by the current
version of the guidance.
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Hormone replacement therapy (HRT): further information on the known increased risk of breast cancer with HRT and its persistence after stopping
New data have confirmed
that the risk of breast cancer is increased during use of all types of HRT,
except vaginal estrogens, and have also shown that an excess risk of breast
cancer persists for longer after stopping HRT than previously thought.
Prescribers of HRT should discuss the updated total risk with women using HRT
at their next routine appointment.
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Statement on the agency’s ongoing efforts to resolve safety issue with ARB medications
Protecting patients is the FDA’s highest
priority, and Americans can be confident in the quality of the products the
agency approves. The recent Angiotensin II Receptor Blocker (ARB) recalls have
deeply concerned patients, the medical community, the agency and international
regulatory bodies. The FDA is aware many patients rely on ARB medicines, and we
are concerned about the presence of nitrosamine impurities in these drugs.
Millions of people benefit from the high-quality products that the FDA
regulates, and the U.S. has the most robust drug supply in the world, with
strict standards for safety, effectiveness and quality.
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White House Highlights ‘Red Flags’ for Illicit Fentanyl
The manufacturing advisory
identifies the various stages of illegal fentanyl manufacturing and
distribution.
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What are suitable Cycles for Re-Qualification?
With the revision of Annex 15 in October
2015, the topic of requalification has become more important. Time intervals
for the assessment of the equipment with regard to the qualification status and
for the requalification itself should be justified. Criteria for the assessment
should be defined. This is sometimes difficult. Chapter 9 of the revised ISPE
Baseline No 5 Commissioning & Qualification of June 2019 on the periodic
review can be helpful here.
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U.S. Urges EU to Delay Implementing EU MDR/IVDR by Three Years
The letter highlights the
lack of notified bodies in the EU to perform certification activities under the
MDR/IVDR.
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New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases
Read more
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Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country
Read more
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What is a Combination Product?
The FDA released a final guidance on postmarketing safety reporting for combination products to further clarify what a combination product is and how applicants can comply with the rules on postmarketing safety reporting requirements (PMSR).
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Alterações ao Estatuto do Medicamento reforçam regulação e supervisão no circuito do medicamento
Entrou em vigor o Decreto-Lei n.º 112/2019, de 16 de agosto, que constitui a décima segunda alteração ao Decreto-Lei n.º 176/2006 de 30 de agosto, diploma que aprova o denominado Estatuto do Medicamento.
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EMA/FDA analysis shows high degree of alignment in marketing application decisions between EU and US
EMA and the US Food and
Drug Administration (FDA) are aligned in more than 90% of marketing
authorisation decisions for new medicines.
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Decreto-Lei n.º 112/2019 - Diário da República n.º 156/2019, Série I de 2019-08-16123962150
Altera o regime jurídico dos medicamentos de uso humano
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How to detect Falsified Medicines
Falsified medicines
repeatedly occur in the supply chain. The MHRA now provides information on how
to detect them.
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Updated reminder on the working documents provided within the eCTD submissions
As per the structure of the
eCTD, the product information should be provided in PDF format within Module
1.1.3. However, occasionally it is necessary to provide, in addition to the PDF
requirement, product information or the Module 2 documents in Word format.
These files should be provided outside of the eCTD structure, in a separate
folder called xxxx-workingdocuments on the same submission zip package as the
eCTD.
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Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) in a no-deal Brexit
Pharmacovigilance system
requirements if there is a no-deal Brexit.
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11 new reference standards and 28 replacement batches released in July 2019
The EDQM announces the availability of:
11 new Ph. Eur. reference standards; 28 replacement batches for Ph. Eur.
reference standards. Information on reference standards removed from catalogue.
Information on change of sales units. Information on changes of storage /
shipping conditions. Information on reference standards currently out of
stock.
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Is the Audit Trail Review required for Electronic Health Records?
MHRA´s GCP inspectors have
recently seen various types of Electronic Health Records (eHRs) during their
investigator site inspections and in several cases they have given major
findings.
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Governo aprovou alterações ao Estatuto do Medicamento
O Governo aprovou em Conselho de Ministros uma
alteração ao Decreto-Lei n.º 176/2006, que estabelece o regime jurídico dos
medicamentos de uso humano, no sentido de “minimizar as situações de rotura de
medicamentos no território nacional”.
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Comissão Europeia disponibiliza novos documentos para implementação dos regulamentos europeus de dispositivos médicos e para diagnóstico in vitro
A Comissão Europeia tem vindo a disponibilizar vários
documentos orientadores para facilitar a implementação dos novos regulamentos
europeus dos Dispositivos Médicos (DM) e dos Dispositivos Médicos para
Diagnóstico In Vitro (DIV). Dirigidos aos diferentes intervenientes do
ecossistema dos DIM e DIV, estes documentos, alguns dos quais em versão
traduzida para português, são disponibilizados pelo Infarmed, na área do site
dedicada à implementação dos novos regulamentos.
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How to quickly find out about FDA requirements for Medical Devices?
In the USA, medical devices
are regulated within the FDA by the Center for Devices and Radiological Health
(CDRH). How can one quickly familiarize oneself with the topic of "medical
devices" or stay up to date? For this purpose, the FDA offers an own
website: CDRH Learn.
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Cursos Eudravigilance no Infarmed em novembro de 2019
Vai decorrer, nas instalações do Infarmed, nos dias 18
a 20 de novembro de 2019, o curso "ISO/ICH E2B(R3) Individual Case Safety
Reporting in the EU: Hands-on Training Course using the EudraVigilance
System", promovido pela Drug Information Association (DIA).
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Substances considered as not falling within the scope of Regulation (EC) No. 470/20091, about residues of veterinary medicinal products in foodstuffs of animal origin
Read more
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Implementação dos regulamentos de DM e DIV - Atualização das orientações da Comissão Europeia
A Comissão Europeia disponibilizou novos documentos
orientadores que visam esclarecer e facilitar a implementação dos Regulamentos
Europeus dos Dispositivos Médicos (DM) e dos Dispositivos Médicos para
Diagnóstico In Vitro (DIV).
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Resolução da Assembleia Legislativa da Região Autónoma da Madeira n.º 23/2019/M - Diário da República n.º 141/2019, Série I de 2019-07-25
Apresenta à Assembleia da República a proposta de lei
que procede à primeira alteração ao Decreto-Lei n.º 124/2018, de 28 de
dezembro, que clarifica as regras aplicáveis à comparticipação de medicamentos
e dispositivos médicos pelo sistema de proteção social dos trabalhadores em
funções públicas.
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Safety Features - how is it progressing?
The MHRA will be issuing a
series of blog posts regarding the implementation of the FMD over the next few
months. The first post looks at the robustness of incoming checks.
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10th Edition of Ph. Eur.: CEP holders are invited to update their applications
CEP holders are invited to update their
applications according to the revised monographs that will be implemented on
the 1st of January 2020 in the 10th Edition of the Ph. Eur., and to follow the
instructions given in the document.
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Essential maintenance to computer applications
Essential maintenance is
scheduled to be carried out to SPOR data services: Referential Management
Services (RMS) and Organisations Management Services (OMS) between between
19:00hrs (CEST) and 20:00hrs (CEST) on Tuesday, 23 July 2019. Applications
consuming real-time RMS data (PSUR Repository, MMS-e, EudraGMDP, EudraCT, EU
PAS (ENCepp), and eAF) will be affected intermittently during this time. Should
you have any questions please contact the EMA IT Service Desk.
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Aviso de indisponibilidade do portal SIATS e das plataformas SMUH-AIM e SMUH-ALTER
Informa-se que, por motivos de manutenção, o portal
SIATS e as plataformas SMUH-AIM e SMUH-ALTER estarão indisponíveis entre as 9h
e as 12h do dia 22/07/2019.
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Certification procedure: revised documents July 2019
The EDQM has revised the following
documents to reflect current practice and clarify a couple of items: Terms of
reference and Code of Practice for the Certification procedure.
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Update of the borderline guideline on medical devices
At what point is a
medical device to be considered a medical device in Europe? The classification
of so-called borderline products is sometimes difficult. An updated EU guideline may be able to help.
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Do liquid, sterile medicinal products have to be particle-free?
According to the
pharmacopoeias, parenteralia, i.e. sterile medicinal products for injection
purposes, must be 100% visually inspected. In addition to damages to the
primary container, the absence of particles has also to be checked. But do
these medicinal products also have to be 100% free of particles? Read more here.
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As of 1 January 2020 the eCTD is mandatory for ALL CEP applications including notifications, revision, renewal and new applications
According to the EDQM
roadmap for electronic submissions for CEP applications, a major change will be
implemented as of 1 January 2020: • eCTD will become mandatory for all CEP
applications. • EDQM will stop accepting NeeS submissions for notifications, revisions
and renewal applications. Therefore, all such submissions need to be in eCTD
format.
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EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers
Read more
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News from the clinical trial portal and database
The new CTR becomes applicable six
months after the notice of the full functionality of the CTIS. The EMA informed
that the CTIS now enters a phase of agile, iterative delivery, to prepare the
system for audit.
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Advice on impacts of using antimicrobials in animals
The European Medicines
Agency (EMA) is involved in monitoring and evaluating the risks of using
antibiotics in animals. It has looked in particular at the risk of the
development of antimicrobial resistance in animals and of the possible
transmission of resistance to humans.
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Pharmeuropa Volume 31 No 3, July 2019
Users of CEPs are invited
to provide comments on draft monographs published in Pharmeuropa 31.3 before 30
September 2019.
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Creams, Gels & Pastes redefined
A revised version of the
Ph. Eur. Monograph Semi-solid preparations for cutaneous application has been
published in Pharmeuropa.
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Medicine shortages: EU network takes steps to improve reporting and communication
Read more
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FDA warns repackers distributing pharmaceutical ingredients, including opioids, for putting consumers at risk
The U.S. Food and Drug Administration
has issued warning letters to three repackers of active pharmaceutical
ingredients (API), B&B Pharmaceuticals, Inc., Asclemed USA, Inc., doing
business as Enovachem and Spectrum Laboratory Products, Inc., for significant
violations of current good manufacturing practice (CGMP) requirements.
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10th Edition of the Ph. Eur.
The 10th edition of the Ph. Eur. will be released in July 2019. The new and revised texts will become official on 1 January 2020.
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QRD product-information annotated template (English) version 10.1 - highlighted
Read more
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Serialisation: New Guidance for EU Inspectors
The European Commission has published an Aide-Memoire to help both manufacturers and inspectors to verify compliance with the safety features regulation.
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Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines
Read more
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More Notified Bodies Give Up on EU MDR/IVD Certification
“Following recent market developments,
we have made the strategic business decision to exit from [notified body
certification] services,” said Lloyd’s Register Quality Assurance.
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ECHA to scrutinise all REACH registrations by 2027
ECHA will start to
evaluate 20 % of registration dossiers in each tonnage band to improve the
compliance of REACH registrations. This will mean approximately 30 % of all
registered chemicals will be checked.
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The Human Medicines (Amendment etc.) (EU Exit) (No. 2) and the Medical Devices (Amendment etc.) (EU Exit) (No. 2) Regulations 2019
These Regulations (which
come into force immediately before exit day) are made to correct drafting
defects and omissions in the Human Medicines (Amendment etc.) (EU Exit)
Regulations 2019 (S.I. 2019/775) and the Medical Devices (Amendment etc.) (EU
Exit) Regulations 2019 (S.I. 2019/791). This is to ensure that the published
policy in relation to the regulation of human medicines and medical devices in
a no deal EU exit scenario is properly reflected in those instruments. Those
instruments, which come into force on exit day, amend the Human Medicines
Regulations 2012 (S.I. 2012/1916 – “HMRs”), associated Medicines (Fees) Regulations
2016 and the Medical Devices Regulations 2002 (S.I. 2002/618 – “MDRs”) to
ensure they are fit for purpose in a no deal EU exit.
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NEW - CMDh Q&As on the implementation of the outcome of the Art. 31 referral on angiotensin-II-receptor antagonists (sartans) containing a tetrazole group
Read more
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United Kingdom's withdrawal from the European Union ('Brexit')
On 29 March 2017, the United Kingdom
(UK) notified the European Council of its intention to withdraw from the
European Union (EU), a process known as 'Brexit'. The European Medicines Agency
(EMA) is making preparations to ensure that it can continue to deliver on its
mission and protect public and animal health after the UK leaves the EU.
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Leuprorelin-containing depot medicinal products
Leuprorelin , See
"List of the medicines affected by the referral (Annex I)", Article
31 referrals, Procedure started
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Control of nitrosamine impurities in sartans: revision of five Ph. Eur. monographs
The European Commission
has issued its final legally binding decision on medicines containing
valsartan, candesartan, irbesartan, losartan and olmesartan on 2 April 2019.
This decision was based on the scientific assessment of angiotensin-II-receptor
antagonists (sartans) containing a tetrazole group performed by the Committee
for Medicinal Products for Human Use (CHMP), the conclusions of which are set
out in Annex I to the European Commission Decision C(2019) 2698 final.
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Two additional countries to benefit from EU-US mutual recognition agreement for inspections
Read more
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Commission Implementing Decision (EU) 2019/939 of 6 June 2019 designating issuing entities designated to operate a system for the assignment of Unique Device Identifiers (UDIs) in the field of medical devices
Read more
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EMA closed 10 June 2019
EMA is closed from 18:30 on Friday 7 June until 7:30 on Tuesday 11 June 2019.
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Alegações em produtos cosméticos
Conforme referido na Circular Informativa n.º
106/CD/100.20.100/2018, de 27/07/2018, o Regulamento (CE) n.º 1223/2009, de 30
de novembro, relativo aos produtos cosméticos, estabelece que os consumidores
devem ser protegidos contra alegações enganosas e garante que a informação
transmitida através dessas alegações é útil, compreensível e fiável, permitindo
aos consumidores tomar decisões informadas e escolher os produtos que melhor se
adequem às suas necessidades e expectativas.
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cGMP Cleaning Validation - FDA's Current Requirements
What do authorities require
regarding cleaning validation? Official GMP inspection reports deliver helpful
answers to this question. Through the Freedom of Information Act, the FDA is
required to publish inspection results. This is particularly the case with
Warning Letters. Here, even details of deficiencies regarding cleaning
validation are included in the Warning Letter.
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Consultation on draft guideline on quality requirements for medical devices in combination products
Read more
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ICH E19 public consultation
A new ICH-E19 draft guideline on the
optimisation of safety data collection in interventional clinical trials and
non-interventional studies has been published by ICH for public consultation.
The guideline objective is to provide internationally harmonised guidance on
when it would be appropriate to use a selective approach to safety data
collection in some late-stage pre-marketing or post-marketing studies, and how
such approach would be implemented. Comments should be submitted by 29
September 2019 to the following email address: ich@ema.europa.eu.
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OMS quer mais transparência no preço dos medicamentos
Os Estados-membros da Organização Mundial da Saúde (OMS)
aprovaram uma resolução que desafia os países a partilharem informações sobre
os preços negociados com a indústria farmacêutica, sugerindo também uma maior
transparência em torno das patentes de medicamentos e resultados de ensaios
clínicos. O documento foi aprovado durante a 72.ª Assembleia Mundial da Saúde,
realizada em Genebra, entre 20 e 28 de maio.
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Revised USP chapter <3> Topical and Transdermal Product Quality Tests
The revised USP general chapter
<3> TOPICAL AND TRANSDERMAL DRUG PRODUCTS - PRODUCT QUALITY TESTS has
been approved.
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Lawmakers Claim Purdue Influenced WHO Opioid Guidelines
A bi-partisan congressional
report claims that Purdue Pharma helped shape World Health Organization
recommendations for prescribing opioids.
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ERS esclarece tratamento de dados em saúde
A Entidade Reguladora da Saúde (ERS) emitiu um parecer sobre o tratamento de dados em saúde, tendo por base o novo Regulamento Geral de Proteção de Dados (RGPD), que exige aos prestadores de cuidados de saúde, independentemente da sua natureza jurídica ou dimensão, uma adequação exigente e cuidada dos seus processos de tratamento de dados pessoais, sempre visando a garantia dos direitos e liberdades dos titulares desses dados.
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New WHO Draft for GDP Guidance
The World Health Organisation WHO plans to revise its Good Storage and Distribution Practice guidelines and to consolidate the rules in one single document.
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Pau de Cabinda - Esclarecimento adicional
A DGAV disponibiliza esclarecimento adicional sobre a
“Proibição do uso de Pau de Cabinda a partir de 14 Maio 2019”.
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Recent GMP defects in process validation
What are the authorities' requirements regarding process validation? Regulatory GMP inspection reports are useful in answering that question. The "Freedom of Information Act" obliges the US FDA to publish all inspection results. The FDA does that particularly when it comes to warning letters.
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2019
Read more
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FDA Lays Out Weight of Evidence Guidelines for Fetal Toxicity in Oncology
The weight of evidence
could include a review of existing literature.
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New office-based GDP-Inspection Process in UK
The U.K. Medicines and Health Products Agency (MHRA) is testing a new, office-based inspection process - without a visit of the site.
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How does the GDPR impact Clinical Trials?
The European Commission released a Question and Answers paper on the interplay between the Clinical Trials Regulation (CTR) and the General Data Protection Regulation (GDPR).
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Implementação das obrigações legais no que respeita aos dispositivos de segurança
Read more
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Medical devices
In early June 2019 EMA will
publish a draft guideline on quality requirements for regulatory submissions
for medicines that include a medical device (drug-device combinations). The
guidance will cover devices which are integral, co-packaged or supplied
separately. The public consultation is expected to last three
months.
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The ICH E8(R1) reaches Step 2b of the ICH Process
The ICH E8(R1) draft Guideline on General Considérations for Clinical Trials reached Step 2b of the ICH Process in May 2019 and has entered the public consultation period.
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Statement from Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D., and Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research
It can be a challenge for
health care professionals and patients to find quality scientific information
about the safety of drugs and biological products when used during pregnancy or
breastfeeding. Ethical challenges often arise in studying women in these
populations as there are valid concerns about maternal and fetal safety.
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Hearing on the SCHEER preliminary Guidelines on the presence of Phthalates in certain medical devices (Brussels, 04 April 2019) - Summary records and presentations now available
Read more
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MedTech Europe Says EU MDR/IVDR Transition is Not Workable
MedTech Europe is warning
European regulators that the EU’s new regulatory system for devices won’t be
ready on time and said the delay will jeopardize patient lives.
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Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
Read more
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Two additional countries to benefit from EU-US mutual recognition agreement for inspections
Read more
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Batch Records: who needs to review?
The Qualified Person (QP)
often reviews the batch documentation personally prior to certification of a
batch. But is the QP obliged to the review of the batch documentation?
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European Parliament Evens Scales for Generics Makers With New SPC Waivers
The European Commission
says the reform will “remove a major competitive disadvantage.”
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Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier, on agency’s new steps to strengthen the process of initiating voluntary recalls
Voluntary recalls are one of the most important safety tools overseen by the U.S. Food and Drug Administration. They are a vital means to protect public health and typically are the quickest way to remove defective or potentially harmful food, medical, and consumer products from the market. The FDA plays an important role in the recall process, closely overseeing FDA-regulated companies during their voluntary recalls to help ensure public health is protected.
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EMA's Annual Report on the EudraVigilance Database
The EMA has published the Annual Report 2018 on EudraVigilance summarizing the current status of the database. Read more
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IndisponibilidadePor motivos de ordem técnica, o site do Infarmed estará indisponível durante o dia 23 de abril (amanhã, 3ª feira). Read more
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Ph. Eur. endorses semi-quantitative HPTLC testing for traditional Chinese medicines
The European Pharmacopoeia
(Ph. Eur.) Commission has decided to accept semi-quantitative High-Performance
Thin-Layer Chromatography (HPTLC) tests as an alternative quality control which
could be used instead of liquid chromatography (LC) assays in monographs on
Traditional Chinese Medicines (TCM).
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GMP for Sterile Containers
Following the Q&As on
what data is required for sterilization processes of primary packaging
materials published in 2016, the EMA recently released the new Guideline on the
sterilization of the medicinal product, active substance, excipient and primary
container.
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Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure
Read more
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019
Read more
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Pharmeuropa Volume 31 No 2, April 2019
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 31.2 before 30 June 2019.
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Manual de Rotulagem de Produtos Fitofarmacêuticos
A DGAV divulga o Manual de Rotulagem de Produtos
Fitofarmacêuticos, produzido com vista a auxiliar os requerentes de
autorizações de venda de produtos fitofarmacêuticos, na rotulagem dos seus
produtos em conformidade com a legislação nacional e comunitária em vigor
aplicável à classificação, embalagem e rotulagem de produtos fitofarmacêuticos.
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EMA Guide on Sterilisation for Medicinal Products, API Excipients and Primary Packaging published
At the beginning of March, the EMA published a guideline for the sterilization of drugs, active ingredients, excipients and also primary packaging.
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Portal Inspeção+
No âmbito do programa SIMPLEX+, estará disponível a partir do
dia 8 de abril de 2019, o portal Inspeção+, que tem como objetivo simplificar a
interação com as entidades do circuito do medicamento e dos produtos de saúde
alvo de ações inspetivas, através da desmaterialização do processo de inspeção
e respetivas respostas, bem como agregar toda a informação deste âmbito.
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Procedimento sobre Gestão da Indisponibilidade do Medicamento
No sentido de contribuir para uma gestão da indisponibilidade do
medicamento mais eficiente e equilibrada, de modo a prevenir a sua ocorrência
ou mitigar o impacto que possa causar no cidadão, o Infarmed publica o
procedimento sobre Gestão da Indisponibilidade do Medicamento.
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First OMCL Network test method for the determination of NMBA in losartan K drug substance published (03/04/19)
Since the start of the sartan crisis in summer 2018, OMCLs of the European Network have elaborated a number of test methods to qualify and quantify nitrosamines in Active Pharmaceutical Ingredients (APIs) and drug products of the sartan group. While at the beginning, work focused on the two major reported contaminants, N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA), laboratories of the Network are now extending their test methods to other potential nitrosamines.
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ICH M10 - Draft Guideline on Validation of Bioanalytical Methods published for public Comments
On 13 March, the European
Medicines Agency (EMA) published a the draft ICH Guideline M10 on bioanalytical
method validation for public comments.
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New EudraVigilance system improves reporting of side effects and detection of safety signals
Read more
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PRAC Takes a Closer Look at Anti-Cancer/Skin Drug
The advisory committee is worried that the drugs may be building up in the bodies of patients who lack a key enzyme.
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MHRA guidance and publications on a possible no deal scenario
Information about the regulation of
medicines and medical devices if the UK leaves the EU with no deal.
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Publication of the ICH M10 draft Guideline and Presentation
The ICH M10 draft Guideline on Bioanalytical Method Validation reached Step 2b of the ICH Process on the 26 February 2019 and now enters the consultation period.
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GMP for Cannabis - What is required?
More and more countries allow cannabis for medicinal purposes - But what are the regulatory requirements?
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Delivery of not ordered goods - what to do?
A wholesaler receives a delivery of a medicinal product. However, the order was not placed. What should be done?
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Medicamentos veterinários: Atualização Brexit
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FDA Scraps Suffixes for Older Biologics’ Proper Names
The agency said it’s unnecessary to change the proper names of biological products that have already received licensing or approval and that lack an FDA-designated suffix.
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EU Commission: How to prepare for a "Hard Brexit"
The European Commission is fostering its support in preparing EU companies for a no deal scenario ("Hard Brexit").
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Sterilisation of the medicinal product, active substance, excipient and primary container
Read more
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MHRA guidance and publications on a possible no deal scenario
Information about the regulation of
medicines and medical devices if the UK leaves the EU with no deal.
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Webinars related to making submissions to the MHRA if the UK leaves the EU with no deal
Links to recorded webinars
which cover how stakeholders can make informed IT plans and preparations in the
event of leaving the EU with no deal.
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Brexit: Handling Pharmacovigilance Data from the UK
How should reports of adverse reactions from the UK be handled after the withdrawal date? New Q&As give a clear answer.
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Atualização da Informação de Medicamentos (alterações C.I.z. IAIN)
O Infarmed solicitou à EMA as seguintes alterações ao template Quality Review of Documents (QRD): - Folheto Informativo - Alteração dos termos "efeitos secundários" para "efeitos indesejáveis"; - RCM e FI - Atualização dos contactos para notificação de suspeitas de reações adversas /efeitos indesejáveis, com a finalidade de privilegiar a utilização do Portal RAM.
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First guidance on new rules for certain medical devices
EMA has published the first of a series of guidance documents to help applicants prepare for obligations stemming from the new EU regulations on medical devices.
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How to make submissions to the MHRA if the UK leaves the EU with no deal
Updated information for stakeholders so they can make informed IT plans and preparations in the event of leaving the EU with no deal.
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Procedural update on submission of Type I variations to EMA in March, April and May 2019
EMA is encouraging marketing authorisation holders (MAHs) intending to submit Brexit-related Type IA and Type IB variations in March 2019 to file these variations as early as possible during the month. This will enable EMA to process the submissions before 29 March so that MAHs can receive confirmation of compliance with the regulatory and legal requirements before this date.
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Information – Withdrawal of the United Kingdom and EU rules on batch testing of medicinal products
Read more
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Nova área sobre o BREXIT
Foi criada uma nova área dedicada ao BREXIT, disponibilizando informação relevante no âmbito deste processo e que pode consultar a partir do menu principal na primeira página do site do Infarmed.
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EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database
The Swiss Agency for Therapeutic Products (Swissmedic) has started in 2019 to enter information on Good manufacturing practice (GMP) compliance as well as on manufacturing authorisations related to Swiss manufacturers into the European Union’s EudraGMDP database.
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Brexit: Safety Features & Multi-Country Packs
Will it be necessary to transfer information about the unique identifier uploaded to the UK repository between 9 February 2019 and the Brexit date to another repository? EMA recently published the answer to this and other related questions.
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The chapter on water: micro determination (2.5.32.) has been revised in the Ph. Eur. Supplement 9.8.
The instrument qualification is carried out according to established quality system procedures, for example using a suitable certified reference material. Sodium aminosalicylate dihydrate for equipment qualification CRS may be used when proceeding by direct or liquid sample introduction, whereas amoxicillin trihydrate for performance verification CRS may be used with the evaporation technique.
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Indisponibilidade dos sistemas de informação
Informa-se que, por motivos de manutenção da infraestrutura, todos os sistemas de informação do Infarmed assim como os e-mails do seu domínio ficarão indisponíveis entre as 18h do dia 15/02/2019 e as 24h do dia 17/02/2019.
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FDA Proposes Voluntary Consensus Standards to Help Speed Drug Reviews
CDER released draft guidance on a proposal to create voluntary consensus standards for drug quality that would help boost innovation and speed up drug reviews.
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Safety Features: Handling of Alerts
The safety feature provisions enetered into force - How to report a falsified pack?
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Elemental impurities reference standards: leaflets now include expanded uncertainty
The EDQM has updated the leaflets of its reference standards for elemental impurities (lead solution CRS, cadmium solution CRS, mercury solution CRS and arsenic solution CRS) with further information to facilitate their use and make traceability transparent. The mass fractions of the assigned element are traceable to the SI units (mole and kilogram) through an uninterrupted chain, similar to certified reference materials established by a national metrological institute.
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FDA Issues Manual on Developing a Shared System REMS
The FDA released a new manual of policies and procedures (MAPP) for developing a shared system risk evaluation and mitigation strategy (REMS).
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Reflection Paper on Further Opportunities for Harmonization of Standards for Generic Drugs available now on the ICH website
The ICH Reflection Paper on Further Opportunities for Harmonization of Standards for Generic Drugs was endorsed by the ICH Assembly in November 2018.
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Current Questions and Answers on Data Integrity and Audit Trail Review
The topic data integrity generates a multitude of questions. Current questions are answered in a loose sequence of News. Question 1: Must there be a concept for evaluating the criticality of data? And what rules for entering critical data into computerised systems must be available? The answers to both questions can be found here.
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Update on the EDQM review of CEP applications for sartan substances (4 February 2019)
Following new information received recently about the presence of nitrosamine impurities in a drug substance covered by a certificate of suitability (CEP), the EDQM has taken immediate action and suspended.
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Document updated - Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to Medicinal products for human and veterinary use
Read more
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Nova área sobre canábis para fins medicinais
No seguimento da publicação da Lei n.º 33/2018, de 18 de julho, que estabeleceu o quadro legal para a utilização de medicamentos, preparações e substâncias à base da planta da canábis para fins medicinais - nomeadamente a sua prescrição e a sua dispensa em farmácia, tendo o Decreto-Lei n.º 8/2019, de 15 de janeiro, procedido à sua regulamentação - esta nova área, com informação selecionada por público (cidadãos, profissionais de saúde e entidades), pretende esclarecer as diretivas emanadas deste novo quadro legal e contribuir para orientar no que respeita à sua aplicação prática.
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EMA starts moving to Amsterdam
The European Medicines Agency (EMA) has started with the relocation to the Netherlands and informs about contact details and continuation of the main activities.
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UK and Russia sign MoU on Regulatory Cooperation on Medicines
Medicines regulators of the UK and Russian set out key principles to support their collaboration on improving public health.
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Diretrizes para a implementação dos dispositivos de segurança (após 9 de fevereiro de 2019)
O regime dos dispositivos de segurança surgiu com a diretiva 2011/62/UE do Parlamento Europeu e do Conselho, de 8 de junho de 2011, que veio introduzir alterações à Diretiva 2001/83/CE que estabelece um código comunitário relativo aos medicamentos para uso humano (art. 54.º A da referida legislação).
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Ph.Eur. Supplement 9.8 available now
The 9.8 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 July 2019.
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How to make regulatory medicines submissions to the MHRA if the UK leaves the EU with no deal
Updated information for stakeholders so they can make informed IT plans and preparations in the event of leaving the EU with no deal.
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New WHO Guideline on Testing of Counterfeit Medicines
The World Health Organization (WHO) has published a new guideline describing the procedure for testing supposedly counterfeit or suspect medicines.
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Conversion of Community Marketing Authorisations to UK Marketing Authorisations – letter to industry
A second letter on conversion of Community Marketing Authorisations providing Product Licence numbers was sent on 2 January 2019 to Marketing Authorisation holders.
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Update on the review of CEP applications for sartans (18 January 2019)
Nitrosamine impurities can be formed due to the synthetic process used to manufacture valsartan and other ARB medicines or they may be introduced into the active substance when recovered materials which are contaminated with these impurities are used in a manufacturing process. Holders of CEPs are therefore requested to immediately inform EDQM of any contamination found in valsartan and or other ARBs manufactured and supplied using a CEP.
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EFSA to share data on open-access platform
EFSA has taken a major step towards becoming a fully open data organisation by committing to publish the scientific data it uses for EU-wide monitoring programmes and surveys and many of its risk assessments.
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Decreto-Lei n.º 8/2019 - Diário da República n.º 10/2019, Série I de 2019-01-15117821810
Regulamenta a utilização de medicamentos, preparações e substâncias à base da planta da canábis para fins medicinais
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Revised guidance for elaborating monographs on radiopharmaceutical preparations: new section on validation of methods
Monographs and general texts on radiopharmaceutical preparations are elaborated by experts in the field. In order to guide experts on the information to be included in European Pharmacopoeia (Ph. Eur.) monographs, and also to harmonise the style of the different monographs, a Guide for the elaboration of monographs on radiopharmaceuticals was published by the EDQM in 2010. This Guide has now been updated to include a section on the validation of methods used in the analysis of radiopharmaceuticals, reflecting the validation requirements applicable to analytical methods included in Ph. Eur. monographs. The new validation section in the revised Guide is the result of a joint effort by Ph. Eur. experts on radiopharmaceuticals and the members of the European Association of Nuclear Medicine’s (EANM) Radiopharmacy Committee.
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TGA Updates GMP Clearance Guidance for Overseas Facilities
The guidance also clarifies when applications will be dropped from the system due to nonpayment and includes a section on troubleshooting and staying up to date with guidance updates.
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Things to Consider for Medical Device Manufacturers when Relocating
In December 2018, the FDA published its finalised guideline entitled "Manufacturing Site Change Supplements: Content and Submission". The first draft dates back to October 2015. Now, who can use this document?
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FDA Releases Data Integrity Guidance in Q&A Format
The FDA issued final guidance on data integrity and compliance with current good manufacturing practices. Commissioner Scott Gottlieb said the agency revised its recommendations in response to stakeholder requests for more details.
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Will EMA Plans change the Landscape of GMP?
EMA has published a strategic reflection paper "EMA Regulatory Science to 2025". As a consequence, the regulatory landscape, including GMP requirements and standards, needs to be adapted.
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Regulation (EU) 2019/5 of the European Parliament and of the Council of 11 December 2018
Amending Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, Regulation (EC) No 1901/2006 on medicinal products for paediatric use and Directive 2001/83/EC on the Community code relating to medicinal products for human use.
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Further guidance note on the regulation of medicines, medical devices and clinical trials if there’s no Brexit deal
Updated information for stakeholders so they can make informed plans and preparations in the event of leaving the EU with no deal.
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Indisponibilidade de sistemas de informação - dia 07/01/2019
Por motivos de manutenção, os seguintes sistemas de informação estarão indisponíveis durante todo o dia 07/01/2019: RNEC, SIOMS, SMUH AIM e ALTER, AUEs, Portal CAUL, Portal RAM, LIC, SIEXPORT, DMFAB e SDIV.
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Restrição do mercado - Produtos destinados à prevenção ou tratamento da cistite contendo proantocianidinas
A Decisão de Execução (EU) 2017/1445 da Comissão Europeia de 08 de agosto de 2017 relativa ao grupo de produtos cujo principal efeito pretendido, dependente das proantocianidinas (PAC) presentes nos mirtilos-vermelhos-americanos (Vaccinium macrocarpon), é a prevenção ou o tratamento da cistite, veio estabelecer que o grupo de produtos acima referido (vulgarmente conhecidos como ¿produtos à base de arandos vermelhos¿ para prevenção ou tratamento da cistite) não está abrangido pela definição de dispositivo médico estabelecida na Diretiva 93/42/CEE do Conselho, de 14 de junho de 1993, relativa aos dispositivos médicos, pelo que estes produtos não devem ser comercializados como dispositivos médicos ostentando a marcação CE.
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Update on the review of CEP applications for sartans
Following new information received recently about the presence of nitrosamine impurities in drug substances covered by certificates of suitability (CEPs), the EDQM has taken immediate actions on CEPs until appropriate corrective actions are implemented by the relevant companies.
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New Ph. Eur Monograph on PAT adopted
The European Pharmacopoeia (Ph. Eur.) Commission adopted 16 new texts including the general chapter on PAT - Process analytical technology (5.25).
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Carregamento de dados no sistema nacional de verificação de medicamentos - MVO Portugal
O INFARMED, I.P., no âmbito dos seus poderes de fiscalização do sistema nacional de verificação de medicamentos, em colaboração com a MVO Portugal, entidade responsável pela criação e gestão desse sistema, efetuou uma avaliação da informação relativa aos Identificadores Únicos (IUs) dos MSRM e MNSRM comparticipados já carregada no mesmo.
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FDA Revises Guidance on CGMPs for Outsourcing Facilities
The agency said it continues to find “concerning conditions and practices” in outsourcing facilities.
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Portaria n.º 326-A/2018
A presente portaria altera e republica a Portaria n.º 314-A/2018, de 7 de dezembro, que procedeu à definição dos países de referência a considerar em 2019, para a autorização dos preços dos novos medicamentos e para efeitos de revisão anual de preços dos medicamentos do mercado hospitalar e do mercado de ambulatório, mantendo, para o mesmo ano, o critério excecional a aplicar no regime de revisão de preços.
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EMA Invites Comments on Water Quality Guideline for Drugmakers
The EMA is seeking stakeholder feedback on a draft guideline on the quality of water for pharmaceutical use.
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New Ph. Eur. Structure of Chapter 3 on Materials and Containers
The Ph. Eur. Commission decided to restructure Ph. Eur. Section 3 on materials and containers. A new Subsection 3.3. has been added to cover items that are classified as medical devices according to EU legislation. Read more about 3.3. Containers for human blood and blood components, and materials used in their manufacture; transfusion sets and materials used in their manufacture; syringes.
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Revision of EMA's Guideline on the Use of Pharmaceutical Water
In the course of the revision of the European Pharmacopoeia which allows the production of WFI with other methods than distillation, the revision of EMA's "Guideline on the quality of water for pharmaceutical use" has become necessary.
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EMA Proposes Decision Tree Approach to Environmental Risk Assessments
The guidance also includes a diagram with steps applicants should take for conducting Phase I and Phase II assessments.
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Mobile scanning and other technologies in the labelling and package leaflet of centrally authorised medicinal products
Read more
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Revisão anual de preços para 2019
Já se encontram disponíveis, na área "Revisão de preços", todos os documentos de apoio à revisão anual de preços de medicamentos não genéricos (mercado ambulatório e mercado hospitalar) para 2019.
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FDA Issues 63 New Product-Specific Guidances for Generic Drugmakers
The FDA is “making the process for copying these medicines more efficient and creating an easier path for generic alternatives to enter the market,” said Commissioner Scott Gottlieb.
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Launch of the new EudraVigilance system: questions and answers from stakeholders
Update Read more
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New ICH Topic Q14 and Revision of Q2
A new ICH topic was endorsed by the ICH Management Committee in November 2018. Read more about the proposed new ICH Q14 guideline Analytical Procedure Development and the revision of Q2(R1) Analytical Validation.
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Guidance on the format of the risk management plan (RMP) in the EU - in integrated format (Rev. 2.0.1)
Read more
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MRA: FDA accepts four new States
The US Food and Drug Administration (FDA) announced that it accepted four new states, which will now benefit from the EU-US Mutual Recognition Agreement MRA.
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Classification of GMP Deficiencies - A new Guideline of the PIC/S
Following the committee meeting at the end of September 2018, the PIC/S working group had elaborated a new guideline on the classification of GMP deficiencies which is going to be adopted.
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Questions and answers (version 12) - Safety features for medicinal products for human use
Read more
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Brexit: EMA to focus on Medicines Evaluation and Supervision
End of September the EMA together with the European Commission organised a meeting with industry stakeholders to discuss the UK's withdrawal from the European Union ("Brexit"). Now the report of the EMA-Industry stakeholder meeting was published.
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Revised Guideline on requirements for revision/renewal of CEPs: corrected version available
N.B. A corrected version of the guidelines is available where under change 4.II.1.1 c) & e) specific documentation 2 has been deleted and under 4.II.1.2. condition 4 has been deleted since superfluous. Read more
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Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’
Read more
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Disabling and potentially permanent side effects lead to suspension or restrictions of quinolone and fluoroquinolone antibiotics
Read more
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Stability by Design - Guidelines for Assessing & Controlling Physical Stability
The USP Physical Stability Joint Subcommittee has published a Stimuli article regarding Guidelines For Assessing and Controlling the Physical Stability of Pharmaceutical Raw Materials, Intermediates, and Dosage Forms.
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Drug Safety Update: monthly PDF newsletter
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor the Commission on Human Medicines
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Valsartan: New Inspection reveals significant GMP Violations
An inspection by EU inspectorates in collaboration with EDQM has revealed significant GMP violations at a Valsartan manufacturer's site.
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Circular nº 1/2018: Instrucción sobre excipientes
Actualización de la información sobre excipientes en la información de medicamentos.
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FDA Guidance Revises Packaging Terms for Injectable Medical Products
The FDA issued final guidance on “single-dose” and “multiple-dose” containers for injectable medical products — introducing a new term “single-patient use.”
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Stability by Design - Guidelines for Assessing & Controlling Physical Stability
The USP Physical Stability Joint Subcommittee has published a Stimuli article regarding Guidelines For Assessing and Controlling the Physical Stability of Pharmaceutical Raw Materials, Intermediates, and Dosage Forms in Pharmacopeial Forum (PF).
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The Ph. Eur. has launched a public consultation on two major texts for the testing of parenteral drugs
The European Pharmacopoeia (Ph. Eur.) Commission is consulting its stakeholders on Ph. Eur. dosage form monograph on Parenteral preparations (0520) and new informative chapter on testing for visible particles (5.17.2).
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FDA Releases FY 2018 Numbers for Fast-Tracked ANDA Generics
The FDA logged a steadily increasing number of fast-tracked ANDAs in fiscal year 2018, according to the agency’s first annual report mandated by the FDA Reauthorization Act.
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Working with stakeholders to improve availability of medicines in the EU
The task force set up by EMA and the Heads of Medicines Agencies (HMA) on availability of authorised human and veterinary medicines is organising a two-day workshop (8-9 November 2018) at EMA in London to gather stakeholders' perspectives on how to better address potential problems with the supply of medicines and how to avoid shortages of medicines.
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Ph. Eur. seeks feedback on general chapter covering depyrogenation in parenteral preparations
The European Pharmacopoeia (Ph. Eur.) has launched a public consultation on its new general chapter 5.1.12 on depyrogenation of items used in the production of parenteral preparations. While depyrogenation is not a new topic for the Ph. Eur., this is the first time that a dedicated chapter covers specifically the inactivation of pyrogens and related endotoxin indicators. Pyrogens are substances that can induce fever when infused or injected and must be removed from materials that come into direct contact with final sterilised products, such as primary packaging and equipment.
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News in the treatment of registration records of dossiers of medicines for human use
Updates regarding the submission of applications for regulatory activities of medicines for human use, with the mandatory use of the eCTD format as of January 1, 2019 in all applications for authorization, variation and revalidation, both under national (NP) and European ( MRP / CP / DCP), establishing a series of exceptions, in purely national procedures, included in Raefar II and indicated in this informative note.
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Training presentations on Active Substance Master File (ASMF) work sharing procedure
New Read more
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Pharmacopoeial discussion group achievements
The face-to-face meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP) and the United States Pharmacopeia (USP)] was hosted by the EDQM in Strasbourg, France, on 2-3 October 2018. WHO participated as Observer.
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Questions and answers related to the United Kingdom's withdrawal from the European Union with regard to the biocides sector
Update Version Read more
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EMA Blocks Aurobindo Pharma From Supplying Irbesartan
EU authorities have increased scrutiny of Chinese API maker Zhejiang Huahai, the valsartan manufacturer linked to the original contamination of APIs used in blood pressure drugs.
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MIT Researchers Develop New Way to Crowd-Source Drug Data
Researchers at MIT say they’ve developed a way for drug sponsors and researchers to share information without compromising private patient details or intellectual property.
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EU guidance for new Medical Device Regulation (MDR)
With the coming into force of the Medical Device Regulation (MDR) in 2020, the guidelines 93/42/EEC and 90/385/EEC, which have regulated the field of medical devices so far, will become invalid. Two EU documents define what is going to change and how the changes need to be implemented.
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Diethanolamine - Suspension of marketing authorizations for veterinary medicines containing diethanolamine for food-producing animals
The DGAV points out that the sale of any veterinary medicine containing Diethanolamine is prohibited. This prohibition covers not only the supply of such medicines by MA holders and Wholesale Distributors of Medicines and/or Veterinary Medicines, but also by pharmacies and Retail Stores of Veterinary Medicines
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EU authorities take further action in ongoing review of sartans: Zheijiang Huahai placed under increased supervision.
Read more
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Fluoroquinolones and quinolones – new restrictions on use
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended restricting the use of fluoroquinolone and quinolone antibiotics.
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FDA Breaks Record for Most Generic Approvals
The FDA broke its generic drug approval record yet again, FDA Commissioner Scott Gottlieb said Thursday, reporting that fiscal 2018 has seen the most approvals and tentative approvals.
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Version 11 of EU Q&As on Safety Features: Specific Questions on Stickers
The European Commission released version 11 of the questions and answers catalogue on safety features in September 2018. It also addresses the placing of safety features by means of stickers in detail. Get more information about safety features in the revised Q&A document of the EU.
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Ph. Eur. Supplement 9.7: CEP holders are invited to update their applications
Supplement 9.7 of the Ph. Eur is now available.
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FDA: Guidance on Quality Chewables
In vitro disintegration tests should be conducted using established disintegration equipment and methods, the FDA says.
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Pharmacovigilance: Be prepared for "Hard Brexit"
The UK Government has released some information regarding the consequences of the Brexit on pharmacovigilance and the establishment of the Qualified Person for Pharmacovigilance (QPPV).
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European Pharmacopoeia: New Chapter on Visual Inspection for Visible Particles
The European Pharmacopoeia has published a new chapter on testing of parenterals for visible, particulate matter in Pharmeuropa 30.4.
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Perguntas e respostas sobre o sistema dos dispositivos de segurança
O sistema dos dispositivos de segurança surgiu com a diretiva 2011/62/EU do Parlamento Europeu e do Conselho, de 8 de junho de 2011 e encontra-se regulado pelo Regulamento Delegado (UE) 2016/161, da Comissão de 2 de outubro de 2015, de aplicação direta na ordem jurídica nacional, e pelo Estatuto do medicamento, na sua redação atual.
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Stock break of the medicine Sinemet - alternatives (postponement)
To ensure that the treatment is available for all patients, it is essential that doctors, pharmacies and distributors manage the available stocks carefully. Patients are also encouraged to pick up the medication at the pharmacies only when needed. It should be noted that any change in treatment should be previously evaluated by the doctor.
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Sponsor Oversight of Clinical Trials - How to improve compliance?
There is no "one size fits all" for the management of clinical trials. However, there is a clear requirement according to GCP that the sponsor retains all responsibility for the conduct and reporting of clinical trials.
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New Q&As on Chapter 3 of the EU-GDP Practice Guide (Premises and Equipment)
The European GDP Association has published new Question & Answers on Chapter 3 of the EU-GDP Guide (Premises and Equipment).
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OMCLs release three methods for determination of NDMA in sartans
Since early July 2018 Official Medicines Control Laboratories (OMCLs) of the General European OMCL Network (GEON) have been involved in investigations and actions to address the issues related to the detection of N-nitrosodimethylamine (NDMA) in valsartan. The Network has meanwhile developed methods for the specific testing of nitrosamines in sartans on the basis different analytical principles.
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Portugal to also benefit from EU-US mutual recognition agreement for inspections
Read more
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CMDh Clarifications on the Implementation of the Falsified Medicines Directive
In April 2018, the CMDh published a document to clarify questions which arose from the original Q&A document dated March 2017 on the implementation of the Falsified Medicines Directive. Read more about the document "CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive".
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FDA Grants First Approvals Via the Competitive Generic Therapy Pathway
The FDA approved drug products under the Competitive Generic Therapy (CGT) designation for the first time, granting approval to several strengths of Apotex’s potassium chloride oral solution.
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FDA Releases Product-Specific Guidances to Foster Generic Competition
One of the most effective ways for the FDA to increase patient access to high quality generics is to offer guidance that promotes the development of cost-saving generics, especially for complex drugs that are difficult to copy, he said.
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FDA awards five grants to advance the development of pediatric medical devices
The U.S. Food and Drug Administration announced today that it has awarded five grants totaling up to $6 million per year over the next five years to Pediatric Device Consortia (PDC) across the country that will provide advice and support services to innovators of children's medical devices.
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New Questions and Answers on Safety Features - EU Q&As Version 10 published!
The safety features required for the implementation of the Anti-Counterfeit Directive will have to be implemented by the 9th February 2019. The European Commission released version 10 of the questions and answers catalogue on safety features in July 2018. Get more details about the revised Q&A document of the EU on safety features.
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New support pages for industry on obligations for hazardous mixtures
The Poison Centres website has been revamped with new support pages providing stepwise help for industry on how to prepare and submit information on hazardous mixtures.
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Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device
Update Read more
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Revised Guideline on requirements for revision/renewal of CEPs
The revised EDQM ‘Guideline on requirements for revision/renewal of Certificates of Suitability to the European Pharmacopoeia Monographs’ (PA/PH/CEP (04) 2 7R) will enter into force in January 2019.
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Sanofi’s Treatment for Blood-Clotting Disorder Approved in Europe
The authorization marks Sanofi’s first approval for a nanobody-based medicine
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FDA Issues Guidance on Controlling Elemental Impurities in Drugs
The FDA finalized its recommendations on how drug sponsors submitting applications should control elemental impurities in their drug products.
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Pre-notification check for type IA variations: ensuring the quality of veterinary type IA variation submissions
Update Read more
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What information is included in a CEP?
The "Certificate of suitability to the Monographs of the European Pharmacopoeia" (CEP) contains information on an active pharmaceutical substance with regard to the European Pharmacopoeia. It is an important document of the authorisation application. Read more about what information is relevant for a CEP and what do CEP holders and authorisation applicants have to consider.
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FDA Issues Draft Guidance on Export Certificates for Device
In cases where the denial is specifically because of a facility’s noncompliance with GMPs, the agency will provide a “substantive summary” of the failures identified.
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FDA Suggests New Flexibility for Blinding Cancer Trials
Cancer patients in clinical trials should be told whether they’ve been given placebos or experimental drugs if their tumors reappear or get worse—and patients and researchers should be told if sponsors are worried experimental drugs may be triggering bad reactions, the FDA says in new draft guidance released Thursday.
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Keeping medicines safe Keeping medicines safe
How EMA monitors medicines once they are on the market
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EMA publishes list of contact details for pharmacovigilance enquiries
The EMA published information extracted from the Article 57 database (xEVMPD) in the form of an Excel document. The file contains a complete list of all medicines authorized in the EEA with marketing authorization holders' dedicated contact details for pharmacovigilance enquiries.
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Update on medicines containing valsartan from Zhejiang Tianyu
Company no longer authorised to manufacture valsartan active substance for EU medicines due to presence of NDMA.
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Launch of the new EudraVigilance system: questions and answers from stakeholders
Update Read more
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FDA approves first generic version of EpiPen
The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds.
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New WHO guideline on medical devices and IVDs
On 76 pages spread over five chapters, the WHO has published a finalised regulatory framework for medical devices, including In-vitro-Diagnostics (IVDs), with the title "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices".
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Pair of Anti-Malaria Drugs Win Approval
The sponsors will conduct post-marketing studies to make sure their drugs are safe and effective for children, elders and the obese.
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FDA approves first-of-its kind targeted RNA-based therapy to treat a rare disease
The U.S. Food and Drug Administration today approved Onpattro (patisiran) infusion for the treatment of peripheral nerve disease (polyneuropathy) caused by hereditary transthyretin-mediated amyloidosis (hATTR) in adult patients.
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FDA approves treatment for two rare types of non-Hodgkin lymphoma
The U.S. Food and Drug Administration today approved Poteligeo (mogamulizumab-kpkc) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
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European Commission publishes revised Version of EU GMP Guideline Annex 2
As consequence of the adopted new regulations of GMP for ATMPs, the European Commission published a revised version of the Annex 2 "Manufacture of Biological active substances and Medicinal Products for Human Use".
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Early access to medicines scheme: expired scientific opinions
Medicines that were granted a positive opinion under the early access to medicines scheme (EAMS) which has now expired.
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Brexit preparedness: EMA to further temporarily scale back and suspend activities
The European Medicines Agency (EMA) will launch the next phase of its business continuity plan on 1 October 2018 at the latest. This will allow the Agency to safeguard core activities related to the evaluation and supervision of medicines, while it has to intensify its preparations for the physical move to Amsterdam in March 2019 and cope with significant staff loss.
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Cooperation of international authorities for inspecting API manufacturers
The aim of the International API Inspection Programme is the cooperation of authorities in monitoring and controlling API manufacturers. Read here, by which measures an optimised bundling and efficiency enhancement of the regulatory supervision of API facilities via GMP inspections are to be reached.
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Collecting Patient Experience Data for Product Development
The FDA recently released a guidance on patient experience data from patients, caregivers, clinicians and others for product development and regulatory decision-making.
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EudraVigilance: how to register
Pharmaceutical companies holding or applying for a marketing authorisation in the European Economic Area (EEA), sponsors of clinical trials and national competent authorities in the EEA need to register with EudraVigilance for the electronic data interchange of pharmacovigilance information. The registration process is a prerequisite for electronic reporting.
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IT systems unavailable from 27 to 30 July 2018
EMA website and online applications will be temporarily unavailable
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United Kingdom wants to remain in the EMA
It's official: the United Kingdom wants to remain in the EMA. This can be gathered from a recent statement by the government.
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Roche’s Tecentriq Gets Breakthrough Therapy Status
The FDA granted a breakthrough therapy designation to Roche’s Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) to treat hepatocellular carcinoma.
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FDA approves first targeted treatment for patients with relapsed or refractory acute myeloid leukemia who have a certain genetic mutation
The U.S. Food and Drug Administration today approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML.
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EU and Japan reinforce their collaboration on inspections of medicine manufacturers
Update of 2004 mutual recognition agreement extends scope to sterile products, active pharmaceutical ingredients and biologicals including vacines.
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CEP document revised: “Implementation of ICH Q3D in the Certification Procedure”
The EDQM document “Implementation of ICH Q3D in the Certification Procedure” has been revised based on experience gained by EDQM since the initial implementation of the policy. Its implementation date is the 1st September 2018.
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EMA’s proactive publication of clinical data a success
First report on unprecedented transparency policy shows high user satisfaction.
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FDA approves the first drug with an indication for treatment of smallpox
The U.S. Food and Drug Administration today approved TPOXX
(tecovirimat), the first drug with an indication for treatment of smallpox.
Though the World Health Organization declared smallpox, a contagious and sometimes
fatal infectious disease, eradicated in 1980, there have been longstanding
concerns that smallpox could be used as a bioweapon.
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New versions of the 4 electronic Application Forms (eAF v. 1.23)
This release includes further integration with OMS for organisation data in proposed and present part of Variation form and other NTA changes. This new version, 1.23 of the forms can be used as of today (13th July 2018) and will fully replace the version 1.22.0.1 after transitional period, on 15 October 2018. The version of the form should not be changed during an ongoing procedure.
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FDA Issues Advice on Limited Population Pathway for Antimicrobials
The FDA released draft guidance for sponsors who want to use the agency’s limited population pathway for antibacterial and antifungal drugs.
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Ph.Eur. Supplement 9.6 available now
The 9.6 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 January 2019.
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FDA Issues Draft Labeling Guidance on Indications and Usage
The FDA released draft guidance outlining the information sponsors should include on the Indications and Usage section of drug and biologics labeling.
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IMPs: EMA updates timeline for portal and database
The EMA has announced a new timeline for the application of the Clinical Trials Regulation due to the EMA`s move to Amsterdam because of the Brexit.
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ICH Q13 supports continuous manufacturing
On 22 June, it became official: the International Council for Harmonisation (ICH) announced in a press release that with the new Guideline ICH Q13, they would support the introduction of continuous manufacturing processes into the pharmaceutical industry.
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FDA Suggests Alternatives for Demonstrating CGMP Compliance for Combination Products
The FDA released a list of alternative suggestions for complying with CGMP requirements for drug combination products that covers stability testing, release for distribution, reserve samples and special testing requirements.
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First two CAR-T cell medicines recommended for approval in the European Union
The European Medicines Agency (EMA) has recommended the first two marketing authorisations for chimeric antigen receptors (CAR) T-cells medicines in the European Union (EU). Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel) are advanced therapies for blood cancer. They belong to a new generation of personalised cancer immunotherapies that are based on collecting and modifying patients’ own immune cells to treat their cancer.
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FDA: Oncology Radiopharmaceutical Labeling Must Include Genotoxicity
Labeling for oncology radiopharmaceuticals must include information on the potential for genotoxicity and adverse reproductive toxicity, the FDA said in new draft guidance.
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ICH M9 reaches Step 2b of the ICH Process
The ICH M9 Biopharmaceutics Classification System-based Biowaivers reached Step 2b of the ICH Process in June 2018 and now enters the consultation period.
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Batch Release without a QP - Is this possible?
Batch certification by a QP is one of the essential requirements in the EU GMPs. However one company in Spain has released products to the market without the QP - with reasonable consequences. Read more
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FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy
The U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome, in patients two years of age and older. This is the first FDA-approved drug that contains a purified drug substance derived from marijuana. It is also the first FDA approval of a drug for the treatment of patients with Dravet syndrome.
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Procedure for orphan-medicinal-product designation: Guidance for sponsors submitting an application via the current existing submission process until 19 Sept 2018
Read more
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FDA approves automated insulin delivery and monitoring system for use in younger pediatric patients
The U.S. Food and Drug Administration expanded the approval of the MiniMed 670G hybrid closed looped system, a diabetes management device that is intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses with little or no input from the user, to include individuals aged 7 to 13 with type 1 diabetes. The FDA originally approved this device in September 2017 for use in patients 14 years of age and older with type 1 diabetes.
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Revision of PIC/S GMP Guide (PE 009-14)
The revised Chapters 3, 5, & 8 of the PIC/S GMP Guide are based on the equivalent Chapters of the EU GMP Guide with some minor differences in terms of language. These Chapters of the PIC/S GMP Guide have now been aligned with principles of Quality Risk Management.
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Quality defects: EMA updates Defective Product Report Template
The European Medicines Agency (EMA) has updated their document for reporting quality defects in drug products.
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FDA Issues Questions and Answers on Implementing ICH S9 Guidance
Cancer drug sponsors facing challenges in implementing the ICH S9 guidance on nonclinical evaluations of their drugs may find answers in a new ICH guidance released by the FDA.
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Time Is Running Out to Prepare for New EU MDR/IVDR: MedTech Europe
One year after the EU finalized its new medical device and in vitro diagnostics regulations there has been little progress in helping industry transition to the new regulations, according to MedTech Europe.
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New PIC/S guidance on GMP inspection reliance based on draft by ICMRA with aim to maximise inspection resources for GMP compliance of overseas facilities
PIC/S has adopted a new guidance on GMP inspection reliance (PI 048-1), which entered into force on 1 June 2018.
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Falsified Medicines Directive - securPharm status report for 2018
There isn't much time left until the safety features required in the future will have to be implemented in order to comply with the Falsified Medicines Directive which will enter into force on 9 February, 2019. The German initiative securPharm has published a status report in this issue for the year 2018.
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Investigational Medicinal Products (IMP): Applicability of the GDP-Guidelines
A new draft EMA
Guideline requires that GDP-Guidelines for medicinal products should be taken
into consideration for IMP shipments.
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Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
June 2018
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Monograph for Water, highly purified (1927) to be suppressed from the European Pharmacopoeia
Following a decision taken by the European Pharmacopoeia (Ph. Eur.) Commission at its 160th session (March 2018), the monograph for Water, highly purified (HPW) will be suppressed on 1 April 2019 from the Ph. Eur. The monograph suppression is a consequence of the recent revision of the monograph for Water for injections (0169), which now allows for purification processes equivalent to distillation for producing water for injections (WFI), in addition to distillation. Hence, the HPW monograph is a duplication of the WFI monograph in terms of quality requirements and production methods, and as such became redundant.
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ICH Q3D(R1) revision reaches Step 2b of the ICH Process
The ICH Q3D(R1) Revision of the ICH Q3D Guideline for Elemental Impurities reached Step 2b of the ICH Process in May 2018 and now enters the consultation period.
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List of safety concerns per approved Risk Management Plan (RMP) of active substances per product
Update Read more
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Unexpected deviation: what is the Role of the QP?
The European Medicines Agency (EMA) has updated its Questions and Answers Section with an amendment to further clarify the role of the QP in the context of handling unexpected deviations.
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List of centrally authorised products requiring a notification of a change for update of annexes
Update. Read more
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Development of antibiotics for children - towards a global approach
The European Medicines Agency (EMA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) and the United States' Food and Drug Administration (FDA) are co-organising a workshop to discuss the development of antibiotics for children.
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Towards harmonisation in the classification of medicines across Europe
The Committee of Ministers of the Council of Europe adopted a revised Resolution on the classification of medicines as regards their supply. It calls on the States Parties to the Convention on the Elaboration of a European Pharmacopoeia (Ph. Eur. Convention) to regularly provide information on their national classifications of medicines for inclusion in the Melclass database and follow the recommendations to classify active substances on the basis of the supply conditions of the medicines that contain them, as listed in the database. The new Resolution CM/Res(2018)1, which supersedes the previous Resolution ResAP(2007)1 from 2007, will continue to play a key role in providing 800 million citizens across Europe with safe access to medicines and to support national authorities in ensuring the appropriate and responsible use of medicines.
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New EDQM guideline "How to read a CEP"
EDQM has elaborated the guideline “How to read a CEP” with the aim of describing in detail the information conveyed on the Certificates of suitability to the Monographs of the European Pharmacopoeia (CEP). This document is intended to give Industry and Competent Authorities clarification on the meaning of the statements laid down on the CEPs.
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FDA Issues Final Guidance on GMPs for APIs
The FDA released final guidance on its Q7 guidelines on good manufacturing practices for active pharmaceutical ingredients, using a question and answer format to clarify the document developed through the International Conference on Harmonization.
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Targeted stakeholder consultation on duplicate marketing authorisations for biological medicinal products
Read more
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FDA approves novel preventive treatment for migraine
The U.S. Food and Drug Administration approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. The treatment is given by once-monthly self-injections. Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule that is involved in migraine attacks.
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FDA approves the first non-opioid treatment for management of opioid withdrawal symptoms in adults
The U.S. FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. Lucemyra is not a treatment for opioid use disorder (OUD), but can be used as part of a broader, long-term treatment plan for managing OUD.
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EU Data Protection Regulation - Impact on Clinical Trials & Pharmacovigilance
The EU Data Protection Regulation will apply from May 25, 2018. It will introduce new data protection requirements in the EU as well as substantial fines for breaches of the data protection rules.
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Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
May 2018 Read more
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FDA expands approval of Gilenya to treat multiple sclerosis in pediatric patients
The U.S. Food and Drug Administration approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in children and adolescents age 10 years and older. This is the first FDA approval of a drug to treat MS in pediatric patients.
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FDA Clarifies the Term ‘Outsourcing Facility’ and Requirements for 503A Compounders
As part of its increased focus on drug compounding, the FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility.
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Roche Gains Priority Review for Tecentriq Combo Treatment in Cancer Patients
The FDA granted priority review for Roche’s Tecentriq (atezolizumab) used in combination with Avastin (bevacizumab), paclitaxel and chemotherapy for the first-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) patients.
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Questions and answers: Good manufacturing practice
This page lists the European Medicines Agency's answers to frequently asked questions, as discussed and agreed by the Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group. The section on “EU GMP guide annexes: Supplementary requirements: Annex 16” was updated.
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Two years of PRIME
In the two years since its launch, the PRIority Medicines scheme (PRIME) of the European Medicines Agency (EMA) has succeeded in driving innovation and improved the efficiency of the development process in therapeutic areas with the most pressing unmet medical needs. The goal is to support and optimise medicine development, so that patients whose diseases cannot be treated or who need better treatment options have access to new medicines that enable them to live healthier lives.
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Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP
Read more
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Evaluation of EMA fee system for the approval and monitoring of medicines:
Public consultation launched today.
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EMA 2017 annual report published
The 2017 annual report published today provides an overview of the work of the European Medicines Agency (EMA) and highlights last year’s major achievements in protecting and promoting public and animal health in the European Union (EU).
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Quality Risk Management: What Inspectors are looking for
ICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these QRM systems in their GMP inspections?
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Q & A: Guideline on setting health-based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities - updated 27/04/2018
Questions and answers on implementation of risk-based prevention of
cross-contamination in production and ‘Guideline on setting health-based
exposure limits for use in risk identification in the manufacture of different
medicinal products in shared facilities’.
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Updated rules for clinical development of vaccines
EMA launches public
consultation on revised guideline on clinical evaluation of vaccines.
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The European Medicines Agency and the Netherlands agree on Seat Agreement
The European Medicines Agency (EMA) and the Netherlands have finalised the text of a Seat Agreement which describes how the Agency, its bodies and its employees will be treated by the Dutch Government once they start operating in the Netherlands. Read more
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Decree-Law no. 26/2018 – National Official Journal no. 80/2018, Series I of 2018-04-24
Changes the legal status of the medicinal products for human use, transposing Directive (EU) 2017/1572.
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Public hearing about medicinal products containing quinolones and fluoroquinolones
It is ongoing the safety review of the medicinal products containing quinolones and fluoroquinolones due to the occurrence of cases of severe and persistent adverse reactions which mostly affect the muscles, joints and the nervous system.
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FDA Issues Final Guidance on API Good Manufacturing Practices Guidelines
The FDA released final guidance on its Q7 guidelines on good manufacturing practices for APIs, using a question and answer format to clarify the document developed through the International Conference on Harmonization.
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FDA Clears First Device to Use Artificial Intelligence to Identify Diabetic Retinopathy
The FDA cleared the first medical device to use artificial intelligence to measure eye disease diabetic retinopathy in diabetic adults. Read more
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Auditing Starting Materials - new APIC Guideline defines Standards
The use of starting materials in the production process for active pharmaceutical ingredients marks the starting point for GMP. But how can the quality of starting materials be ensured?
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Resolution no. 481/2018 – National Official Journal no. 75/2018, Series II of 2018-04-17
Change of the list of Previous Notification of transactions of medicinal products to outside the country.
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Meeting highlights from the PRAC: 9-12 April 2018
The Pharmacovigilance Risk Assessment Committee (PRAC) has started a review of the risk of dosing errors with methotrexate medicines, used to treat cancers such as acute lymphoblastic leukaemia and various inflammatory conditions including rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis and psoriatic arthritis.
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Increasing oversight of API manufacturing through international collaboration
The European Medicines Agency (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight of active pharmaceutical ingredient (API) manufacturers worldwide, as highlighted in the International API inspection programme report for 2011-2016, published today. APIs are the substances responsible for the activity of a medicine.
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Redistribution of UK’s portfolio of centrally authorised products
The EU27 Member States and the European Medicines Agency (EMA) have completed the reallocation of the medicines for which the United Kingdom’s (UK) Medicines and Healthcare products Regulatory Agency (MHRA) and Veterinary Medicines Directorate (VMD) are currently rapporteur or co-rapporteur appointed by the scientific committees to coordinate the evaluation of a medicine.
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Transitional period applicable to the new Regulations of Medical Devices and In Vitro Diagnosis Medical Devices
In the context of the group of Competent Authorities for Medical Devices and In Vitro Diagnosis Medical Devices in what concerns inspection of the market and clinical investigation (CAMD), a Task Force was established (CAMD Transition Sub Group), with the purpose of discussing the content, harmonize the interpretation and clarify the rules related to the transitional period applicable to the new Regulations of Medical Devices and In Vitro Diagnosis Medical Devices.
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Revised: guideline “Validation of Computerised Systems”
Since the adoption of the first version of the “Validation of Computerised Systems” guideline in May 2009, most of the Network members have introduced computerised systems e.g. Laboratory Information Management Systems (LIMS) and electronic document management systems into their labs which have become commonly used working tools of the Network. For that reason and also based on experiences gained during Mutual Joint Audits, the guideline has been profoundly restructured and revised.
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Draft addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address paediatric-specific clinical data requirements - First version
Draft: consultation open
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How to prepare for an inspection?
GDP inspections by supervisory authorities have grown in number and intensity. Many partners in the distribution chain also have customer audits to face. What does the ideal preparation for a GDP inspection look like?
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MHRA GxP Data Integrity Definitions and Guidance for Industry
MHRA has produced draft GxP data integrity guidance for industry and we welcome your comments.
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Public consultation concerning the EU template for GMP non-compliance statement
Deadline for comments: 15/05/2018
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Rapid implementation of the monograph Products of fermentation (1468).
Due to the public health risk associated with histamine contamination, further requirements related to the quality of raw materials have been added to the Raw materials section of the monograph on Products of fermentation (1468). The implementation date for the revised monograph was 1 April 2018.
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FDA expands approval of Blincyto for treatment of a type of leukemia in patients who have a certain risk factor for relapse
The U.S. Food and Drug Administration granted accelerated approval to Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) who are in remission but still have minimal residual disease (MRD). MRD refers to the presence of cancer cells below a level that can be seen under the microscope. In patients who have achieved remission after initial treatment for this type of ALL, the presence of MRD means they have an increased risk of relapse.
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Technical expert seminar on pharmaceuticals related matters, following UK withdrawal (8 March 2018)
The
European Commission DG SANTE convened a technical expert seminar on
pharmaceuticals related matters in order to discuss matters related to
preparedness of the UK withdrawal.
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Retinoids – new recommendations on the risks of teratogenicity and neuropsychiatric disorders
The European Medicines Agency (EMA) has completed its review of retinoid medicines, and confirmed that an update of measures for pregnancy prevention is needed. In addition, a warning on the possibility that neuropsychiatric disorders (such as depression, anxiety and mood changes) may occur should be included in the prescribing information for oral retinoids.
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EU recommendations for 2018/2019 seasonal flu vaccine composition
The European Medicines Agency (EMA) has issued the European Union (EU) recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2018.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 March 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval, including one orphan medicine, at its March 2018 meeting.
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ECA Data Integrity Task Force issues Version 2.0 of Data Integrity Guide
With the authorities' increasing attention to data governance and data integrity the ECA's Data Integrity Task Force's just released version 2.0 of its Data Integrity Guide provides an ideal tool for implementing data integrity in practice.
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Clinical Trial Regulation
The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trial Regulation comes into application in 2019. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via an EU portal and database. The European Medicines Agency (EMA) will set up and maintain the portal and database, in collaboration with the Member States and the European Commission.
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Common issues identified during clinical trial applications
This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them.
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Additional Data requested for New Applications in the Mutual Recognition and Decentralised Procedures
Read more
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FDA Adopts Final ICH M7(R1) Mutagenic Carcinogen Guideline
Potential or actual impurities in drugs should be studied for their mutagenic properties, according to a revision to an ICH guideline addendum on mutagenic carcinogens, now adopted by the FDA.
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European Pharmacopoeia Reference Standards recently released
9 new Ph. Eur. Reference Standards (RS) were released in February 2018.
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FDA Releases Finalized Q&A Guidance on Choosing Chemical Drug Starting Materials
The FDA finalized a Q&A guidance clarifying the International Council for Harmonization’s November 2012 Q11 guidance on development and manufacture of drug substances — giving recommendations for information that should be provided in authorization applications for starting materials.
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CMDh procedural advice on changing the RMS - Track version
In exceptional circumstances, a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS). The change may be needed when a MAH or a subsidiary responsible for the communication on behalf of the MAH has been closed in the RMS, or when a medicinal product has more than one RMS for the different pharmaceutical forms of the medicinal product, or, subject to clear justification, due to the sunset clause in the RMS. These are examples and other reasons might be justified.
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Four more EU Member States benefit from EU-US mutual recognition agreement for inspections
The mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories is progressing as planned. The US Food and Drug Administration (FDA) confirmed the capability of four more EU Member States (Czech Republic, Greece, Hungary, and Romania) to carry out good manufacturing practice (GMP) inspections at a level equivalent to the US. There are now a total of 12 Member States whose inspection results the FDA can rely on to replace their own inspections.
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Revision of EU GMP Chapter 1 to enhance Quality Risk Management
The European Medicines Agency (EMA) is planning to revise Chapter 1 of the EU-GMP Guidelines. In the new document, risk-based approaches will be included to prevent drug shortages.
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FDA to Require GCP Compliance for Device Trials That Rely on Foreign Clinical Data
Next year, the FDA will begin to require that data from medical device studies conducted outside the U.S. be gathered in accordance with good clinical practices, including review and approval from an independent ethics committee and well-documented informed consent.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 February 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended five medicines for approval, including two orphan medicines, at its February 2018 meeting.
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New standards for haemophilia patients care in Council of Europe Resolution
The Council of Europe’s decision-making body, the Committee of Ministers, adopted Resolution CM/Res(2017)43 on principles concerning haemophilia therapies at the end of 2017. Elaborated by the European Committee on Blood Transfusion (CD-P-TS) on the basis of the recommendations from the Wildbad Kreuth Initiative IV meeting « Optimal use of clotting factors and platelets » of 2016*, the new Resolution replaces Resolution CM/Res (2015)3 on the same subject and calls on governments to take into account specific principles for the treatment of haemophilia and care for haemophilia patients.
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Medical devices: UK notified bodies
UK notified bodies listed under medical device directives.
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EMA's GMP Plans for 2018
The European Medicines Agency has published the 2018 Work Plan. The EMA plans some new guidance and some revisions to existing requirements.
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Highlights from the twelfth industry stakeholder platform on the operation of pharmacovigilance in the European Union
Read more
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New versatile reference standard for equipment qualification
The EDQM announces the availability of a new reference standard: Sodium aminosalicylate dihydrate for equipment qualification CRS 1 replacing the former Amoxicillin trihydrate for performance verification CRS, which will be discontinued as of 1 April 2018.
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Health-EU Newsletter - Assessing health technology in the EU: Commission proposes to reinforce cooperation amongst Member States
Read more
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Quality Risk Management: What Inspectors are looking for
ICH Q9 is the major guideline providing principles and examples of tools for Quality Risk Management (QRM). But how do competent authorities look at these systems in their GMP inspections?
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FDA Publishes Guidance on Microbiology Data for Antibacterial Drugs
Sponsors of systemic antibacterial drugs should evaluate their products against test panels of relevant bacteria and against approved drugs with similar mechanisms of activity, the FDA said, in a newly revised guidance.
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How is the Data Governance System to be implemented in your Company?
The PIC/S draft guideline "Good Practices for Data Management and Integrity" requires every company to have a data governance system in place in addition to their existing QM system. But how can such a system be implemented?
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Question & Answers on Chapter 1 QUALITY MANAGEMENT of the EU Good Distribution Practice Guideline
The European GDP Guideline which has been published in a revised version on 7 March 2013 has caused a lot of discussion since then. Many requirements leave room for interpretation. On the GDP Association Webpage a section has been set up with frequently asked questions (FAQs).
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UK and China sign Memorandum of Understanding on Medicine and Device Regulation
The agreement pledges new areas of cooperation such as an exchange of learning from the accelerated access review (AAR) and how to effectively regulate the trading of medicines online.
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Evaluation of advanced therapy medicines
The European Medicines Agency (EMA) has updated its procedural advice on the evaluation of advanced therapy medicinal products (ATMPs). The update aims to streamline some procedural aspects, strengthen collaboration between EMA’s scientific committees and address specific needs of ATMP developers in the evaluation procedure for initial marketing authorisations, to help developers of these medicines – often small and medium-sized enterprises (SMEs) or academic spin-offs – navigate the regulatory process in the EU.
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Regulatory requirements for Audit Trail Reviews
Audit Trails and their reviews are an important requirement in the current GMP policies. Specific requirements can be found in a number of guidelines, these days. Despite that, many questions about the specific implementation of this complex topic into practice remain.
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The EDQM "Guidance for electronic submissions for CEPs applications" has been revised and application forms have been updated accordingly
The EDQM has revised the document «Guidance for electronic submissions for Certificates of Suitability (CEPs) applications».
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2018
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended seven medicines for approval, including one orphan medicine, at its January 2018 meeting.
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Ordinance no. 36/2018 – National Official Journal no. 19/2018, Series I of 2018-01-26
Determines that the measures of treatment of patients with ichthyosis benefit from an exceptional reimbursement regimen.
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FDA Clarifies Conditions for Mixing, Diluting or Repackaging Biologics
The FDA issued a final guidance on approved biologics that are mixed, diluted or repackaged, noting when the agency will not take action against violations of its standard rules on product misbranding and false and misleading labeling.
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EFSA confirms health concerns for hydroxyanthracene derivatives in food
Some substances belonging to a group of plant ingredients known as hydroxyanthracene derivatives can damage DNA and may cause cancer, said EFSA after assessing their safety when added to food.
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236 substances shortlisted for possible regulatory action
ECHA has selected 236 substances for further scrutiny by the Member State competent authorities in its annual screening exercise. The competent authorities will carry out a manual examination of dossiers they prioritise to decide whether regulatory action is needed.
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Pharmeuropa Volume 30 No 1, January 2018
Users of CEPs are invited to provide comments on draft monographs published in Pharmeuropa 30.1 before 31st March 2018.
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International Drugmakers Plan for Higher Costs as Brexit Looms
Testifying before a UK House of Commons committee last month, international pharmaceutical companies said they are already hedging their bets when it comes to the real-world consequences of Brexit, making preparations for new hurdles in manufacturing and duplications of batch release testing that could cost millions of pounds per year. Read more
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New Annex 1: Consequences for the QP
The new draft of Annex 1 (Manufacture of Sterile Medicinal Products) will be much more extensive and contain some new rules and additions. There are also some things in the Annex 1 draft QPs need to consider.
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MHRA update to pharmaceutical companies on exit preparations
An update from the Medicines and Healthcare products Regulatory Agency (MHRA) to pharmaceutical companies on preparations for exiting the European Union.
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Chair of EMA’s committee for orphan medicines receives award for outstanding patient engagement
Bruno Sepodes, Chair of the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP), has received the EURORDIS European Rare Disease Leadership Award as recognition of his commitment to involve patient advocates in all discussions and decisions related to orphan medicines.
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PRAC recommends suspending hydroxyethyl-starch solutions for infusion from the market
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorisations for hydroxyethyl-starch (HES) solutions for infusion across the European Union. These products are used as plasma volume replacement following acute (sudden) blood loss, where treatment with alternative products known as ‘crystalloids’ alone is not considered to be sufficient.
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FDA acts to protect kids from serious risks of opioid ingredients contained in some prescription cough and cold products by revising labeling to limit pediatric use
The U.S. Food and Drug Administration announced that it is requiring safety labeling changes to limit the use of prescription opioid cough and cold medicines containing codeine or hydrocodone in children younger than 18 years old because the serious risks of these medicines outweigh their potential benefits in this population. After safety labeling changes are made, these products will no longer be indicated for use to treat cough in any pediatric population and will be labeled for use only in adults aged 18 years and older. Labeling for the medications also is being updated with additional safety information for adult use – including an expanded Boxed Warning, the FDA’s most prominent warning ‒ notifying about the risks of misuse, abuse, addiction, overdose and death, and slowed or difficult breathing that can result from exposure to codeine or hydrocodone.
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GMP Update - what's new in the EU?
The GMP world was turning a bit slower in 2016 - now, it's picking up speed again. Currently, several crucial changes are being made with consequences even for national legislation. Read more
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Approval and Definition of Medicinal Products Prices – New forms
The forms for calculation of the prices of non-generic medicinal products from out-patient and hospital market, as well as of generic medicinal products, and their respective filling instructions have been updated. Read more
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MSs Recommendations on Extension Applications in Mutual Recognition and Decentralised Procedures
Read more
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PRAC recommendations on signals adopted at the PRAC meeting of 27-30 November 2017
Read more
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Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices
The FDA announced additional steps to encourage generic competition as part of the continued implementation of the Drug Competition Action Plan. Read more
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Pharmeuropa: Texts for comments
Pharmeuropa issue 30.1 is now complete. Submit your comments until 31 March 2018. Read more
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FDA Clarifies Pathways for Medical Device Accessories
For the third time in under a year, the FDA issued a final guidance on medical device accessories, clarifying that a New Accessory Request can be included as part of a PMA, PMA supplement or a 510(k) submission. Read more
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FDA permits marketing of device to treat diabetic foot ulcers
Today, the U.S. FDA permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.
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Southern Member States update the guide concerning applications for market authorisation of phytopharmaceutical products
Working Document on
the Work-sharing of the Southern Zone Member States under Regulation EC
1107/2009, revision 7.0.
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Extension of pilot for splitting of MRP/DCPs
Update on the "Extension of pilot for splitting of
MRP/DCPs".
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Annual Price Revision for the Generic Medicinal Products 2018
Binding Information Newsletter no. 171, from 22-12-2017.
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Annual Prices Revision 2018 - amendment
Phagecon hereby informs that Ordinance no. 359/2017, of 20 November, which proceeds with the definition of the reference countries, to be considered in 2018, for the authorisation of the prices of the new medicinal products and for purposes of annual prices revision of the hospital market and ambulatory market medicinal products, as well as it keeps, for the same year, the exceptional criterion to apply in the prices revision regimen, published in the National Official Journal, 1st series, no. 223, of 20 November 2017, has been amended. In the no. 2 of article 4, where it is read: «2 - From the suspension foreseen in the previous number are excluded the generic medicinal products which maximum PVP is higher than the maximum PVP of the reference medicinal product, being these subject to annual revision, in accordance with article 17 of Ordinance no. 195-C/2015, of 30 June, in its current wording.» it should be read: «2 - From the suspension foreseen in the previous number are excluded the generic medicinal products whose maximum PVP is higher than the maximum PVP of the reference medicinal products resulting from the 2018 annual revision, and those medicinal products should reduce the PVP in order not to overcome the price of the reference medicinal product.» We also inform that the amendment declaration was published in National Official Journal and is available at:
Read more
https://dre.pt/web/guest/home/-/dre/114394848/details/maximized?serie=I&day=2017-12-22&date=2017-12-01
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Targeted stakeholders consultation on the revision of annex 1, on manufacturing of sterile medicinal products, of the Eudralex volume 4
Read more
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Now online: Draft ICH Q12
The long awaited and highly discussed ICH Q12 draft Guideline is now available online on the ICH website. Read more
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New WHO Guideline for Medical Devices and IVDs
The WHO has published a finalised 76-page regulatory framework for medical devices including in vitro diagnostic medical devices (IVDs) divided into 5 chapters. Read more
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Ph.Eur. Supplement 9.5 available now
The 9.5 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 July 2018. Read more
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The associations representing the European and British life science industry have launched a joint policy document on the potential impact of the United Kingdom’s exit the European Union
Organisations representing the life science industry in the EU and the UK have called for medicines to be a priority in phase 2 of the Article 50 negotiations. Read more
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European Pharmacopoeia Commission adopts a new monograph for Infliximab concentrated solution ‒ the first monograph on a monoclonal antibody
The European Pharmacopoeia (Ph. Eur.) Commission has achieved an important milestone in the field of biotherapeutic products at its 159th Session, held in Strasbourg on 21-22 November 2017, with the adoption of the monograph for Infliximab concentrated solution (2928). Read more
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New FDA Guidance Narrows Agency Oversight of Digital Health Products
The FDA published three new guidances on digital health products that limit the types of products the agency will regulate as medical devices. Read more
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Suppression of the Test for Abnormal Toxicity from the European Pharmacopoeia
During its 159th plenary session, held in Strasbourg on 21-22 November 2017, the European Pharmacopoeia Commission endorsed the complete suppression of the test for abnormal toxicity from the European Pharmacopoeia (Ph. Eur.). Read more
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Draft DIN EN ISO Injection Vials made of Tubular Glass
The DIN EN ISO committee published a draft for DIN EN ISO 8362-1 Injection vials made of glass tubing for comment. Read more
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Questions and Answers related to the United Kingdom's withdrawal from the European Union with regard to national authorised medicinal products for human use
Read more
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FDA approves first biosimilar for the treatment of certain breast and stomach cancers
The U.S. Food and Drug Administration approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.
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Track & Trace: New Questions and Answers published by the EU
The next version 8.0 of the catalogue containing questions and answers on practical implementation and technical aspects of serialisation requirements as per delegated act EU 2016/161 has become available on 22 November. Find more information about version 8.0 of the Q&A on EU FMD DR regarding serialisation. Read more
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Guidance to help pharma companies prepare for Brexit
The European Medicines Agency (EMA) has published additional guidance to help pharmaceutical companies to prepare for United Kingdom's (UK) withdrawal from the European Union (EU). Read more
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COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017
Regulation on the list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the Council. Read more
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New EudraVigilance system is live
The European Medicines Agency (EMA) has launched a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new system makes it easier for marketing authorisation holders and sponsors of clinical trials to report suspected adverse reactions and allows for better analysis of this information for the benefit of patient safety in Europe. Read more
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GVP Update 2017
There have been recent developments within EudraLex Volume 9 - Guidelines on good pharmacovigilance practices (GVP). Read more
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CMDh Guidance on the Informal Work-Sharing procedure for follow-up for PSUSA for NAPs
Public consultation - comments should be sent to H-CMDhSecretariat@ema.europa.eu by 19 January 2018, coordinated where possible by trade associations. Read more
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Ordinance no. 359/2017 – National Official Journal no. 223/2017, Series I of 2017-11-20
Proceeds to the definition of the reference countries to be considered in 2018 for the authorization of the prices of the new medicinal products and for effects of annual prices revision of the hospital market and outpatient market medicinal products, as well as it keeps, for the same year, the exceptional criterion to be applied in the prices revision regimen. Read more
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FDA's new Guidances on the Approval of Generic Drugs
The FDA has recently published various guidelines on application procedures for generics. Read more
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EudraVigilance: EMA's new Signal Management Guide
In line with the go-live date of the new EudraVigilance database EMA now published the revised GVP module IX on signal management. The revised module IX will introduce major procedural changes for industry. Read more
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Order no. 9879/2017 – National Official Journal no. 220/2017, Series II of 2017-11-15
Determines the termination of the obligation of acquisition, by the entities of the National Health Service, of generics or biosimilar equivalent to those foreseen in the annexes to Orders no. 2326/2017, no. 9586/2016 and no. 10858/2015 and foreseen in the no. 2 of the referred orders, under the public procurement contracts (CPA), from the date that generic or biosimilar medicinal products reimbursed or with previous assessment decision equivalent to those foreseen in the annexes to the orders mentioned above are advertised by INFARMED - National Authority of the Medicines and Health Products. Read more
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Guideline on good pharmacovigilance practices (GVP): Module VII – Periodic safety update report - Explanatory note
Adopted Read more
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 6-9 November 2017
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended ten medicines for approval, including two orphan medicines, at its November 2017 meeting. Read more
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The ICH E11 Addendum on clinical investigation in children now enters into implementation
The International Council for Harmonisation, ICH, recently informed that the "E11(R1) Addendum on Clinical Investigation of Medicinal Products in the Pediatric Population reached Step 4 of the ICH Process in August 2017 and now enters into the implementation period (Step 5)". The "Addendum is proposed to address new scientific and technical knowledge advances in pediatric drug development and update the ICH E11 Guideline adopted in 2000". Read more
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Data Integrity from an Inspector's Point of View
Even though the integrity of data has always been one of the basic principles of GMP, the topic has come more and more into the focus in inspections of the last 3-4 years. Read more
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Positive Balance for Implementation of the Falsified Medicines Directive
The soon-to-be required safety features for the realisation of the Falsified Medicines Directive must be implemented by February 09, 2019. The German initiative securPharm strikes a positive mid-term balance. Read more
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FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer
The U.S. Food and Drug Administration expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare cancer of the blood. Zelboraf is indicated to treat patients whose cancer cells have a specific genetic mutation known as BRAF V600. This is the first FDA-approved treatment for ECD. Read more
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FDA to Recognize GMP Inspections From Eight EU Countries
The FDA will begin to recognize manufacturing facility inspections conducted by drug regulatory authorities in Austria, Croatia, France, Italy, Malta, Spain, Sweden and the U.K as capable of meeting the agency's requirements, as part of 1998 agreement between the U.S. and the European Union renegotiated earlier this year. Read more
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IMDRF Clarifies When Competent Authorities Can Share Confidential Information
The International Medical Device Regulators Forum released final guidance that lays out procedures for sharing confidential postmarket surveillance for medical devices among regulators. Read more
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EU-FDA mutual recognition of inspections of medicines manufacturers enters operational phase
1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other's inspection outcomes and hence for better use of inspection expertise and resources. Read more
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FDA to Adopt ICH E9 Addendum on Clinical Trials Analyses
The FDA is seeking public comments on an ICH addendum to a 1998 clinical trials statistics guideline focused on the use of sensitivity analyses and targets for estimation and measurement. Read more
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Position Paper concerning Applicants’ request of submission of multiple applications during ongoing DCPs or inclusion of new CMS or additional strength(s) in an already ongoing DCP
Member states have been approached by applicants requesting submission of multiple applications during ongoing DCP or inclusion of new CMS or additional strength(s) in already started DCP procedures. This position paper provides the position reached by the CMDh. Read more
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Program of Early Access to medicinal products – new regulation
Decree-Law no. 115/2017, of 7 September, which gave a new wording to article 25 of Decree-Law no. 97/2015, of 1 June, amended the conditions of exceptional use authorisation of medicinal products with marketing authorisation, establishing that, since the MA date and during the legally foreseen deadline for the previous assessment procedure, the supply of the medicinal products object of exceptional use authorisation is performed under the Early Access Program to medicinal products. Read more
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Summaries of scientific recommendations on classification of advanced therapy medicinal products
The European Medicines Agency´s Committee for Advanced Therapies delivers scientific recommendations on whether a medicine can be classified as an advanced therapy medicinal product (ATMP). The Agency publishes the outcomes of these assessements in the format of summary reports.
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Specified Microorganisms - Harmonisation of the pharmacopoeial Chapters completed
The International Council for Harmonisation (ICH) finalized their recommendation relating to the use of pharmacopoeidal texts on tests for specified microorganisms. Read more
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PRAC recommendations on signals adopted at the 25-29 September 2017 PRAC meeting
Adopted Read more
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New action plan to foster development of advanced therapies
The European Commission's Directorate-General for Health and Food Safety (DG SANTE) and the European Medicines Agency (EMA) have published today a joint action plan to foster the development of advanced therapy medicinal products (ATMPs). The main aim is to streamline procedures and better address the specific requirements of ATMP developers. Read more
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FDA Issues Draft Bioequivalence Guidances for 30 Drugs, Revises 17
The FDA published new product-specific draft guidances for 30 active ingredients - including cancer therapies, asthma treatments, epinephrine auto-injectors and anti-infectives - outlining the agency's preferred methods for supporting ANDA submissions. Read more
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FDA approves CAR-T cell therapy to treat adults with certain types of large B-cell lymphoma
The U.S. Food and Drug Administration approved Yescarta (axicabtagene ciloleucel), a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor (CAR) T cell therapy, is the second gene therapy approved by the FDA and the first for certain types of non-Hodgkin lymphoma (NHL). Read more
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New EU GMP Guideline for IMPs
The EU Commission published two new GMP documents in the Official Journal of the European Union. Read more
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FDA Clarifies Approval Pathways for ANDA, 505(b)(2) Applications in New Draft Guidance
In new draft guidance, The FDA describes which abbreviated approval pathways are available for ANDAs and 505(b)(2) applications. Read more
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ICH Finalizes Q&A Doc on Justifying Drug Starting Materials
The ICH finalized a Q&A document clarifying its advice on the selection and justification of starting materials used in drug manufacturing. Read more
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Ph. Eur. Supplement 9.4
Supplement 9.4 of the Ph. Eur. is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of April 2018, and to follow the instructions given in the document. Read more
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EDQM and ANVISA sign Memorandum of Understanding on use of CEPs in Brazil
The European Directorate for the Quality of Medicines & HealthCare (EDQM) and ANVISA, the Health Surveillance Agency of Brazil, have signed a Memorandum of Understanding which lays the foundation for ANVISA to consider the use of Certificates of Suitability to the monographs of the European Pharmacopoeia (CEPs) for their evaluation of marketing authorisation applications (MAAs) for medicinal products. Read more
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Handling of Changes to Medical Device Products for approved Combination Products
In a recent news you could read about a question-and-answer document from the EMA, describing certain issues concerning the handling of changes after approval ("variations"). This document has been updated again. The topic of changes to medical devices after the approval of "combination products" has now been added. Read more
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Better labelling of excipients for safe use of medicines
The European Medicines Agency (EMA) and the European Commission have updated the annex to the European Commission guideline on excipients in the labelling and package leaflet of medicinal products for human use. Read more
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Questions and Answers - ICH guideline Q11 on development and manufacture of drug substances (chemical entities and biotechnological / biological entities)
This Question and Answer document is intended to provide additional clarification and to promote convergence and improve harmonisation of the considerations for the selection and justification of starting materials and of the information that should be provided in marketing authorisation applications and/or Master Files. The focus of the Q&A document is on chemical entity drug substances. Read more
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Changes in the presentation of translations of European and national registration procedures
Implementation of updates in the submission and loading of texts proposals with the medicinal product information and the translations for their revision during the national phase of marketing authorisation application procedures and subsequent variation procedures. Read more
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Medical devices: software applications (apps)
Information on when software applications are considered to be a medical device and how they are regulated. Read more
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FDA improves access to reports of adverse drug reactions
The U.S. Food and Drug Administration launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA's Adverse Event Reporting System (FAERS). The tool is designed to make it easier for consumers, providers, and researchers to access this information. Read more
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Exploring opportunities for collaboration between regulators and healthcare payers
The European Medicines Agency (EMA) and European Union (EU) healthcare payers met for the first time on 19 September 2017 at EMA's offices in London to explore synergies and foster mutual understanding and cooperation to help improve timely and affordable access of patients to new medicinal products. The meeting aimed to be complementary to EMA's existing cooperation with health technology assessment (HTA) bodies and especially with EUnetHTA. Read more
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FDA Finalizes Guidance on Drug/Device Combination Product Classifications
The FDA finalized guidance on its process for assigning applications to a specific regulatory center, hoping to answer frequently asked questions from industry sponsors regarding whether their product will be classified as a drug or as a device. Read more
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Qualification of Development Tools for Medical Devices - Guidance for Industry
The topic of development has been playing an important role for the FDA, not only in the pharmaceutical sector, but also with regard to medical devices for quite some time. An FDA draft guidance document on the qualification of development tools from 2013 has now been finalized. Read more
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Free Webinar on CEP Revisions - Sign up today!
This webinar will outline the process for applying for revisions of CEP application files and give advice on how to obtain their fast acceptance. Learn about the revisions process, the correct classification of changes, and how to prepare and organise the documentation. Read more
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LC and GC columns in monographs
With a view to improving the correspondence between liquid chromatography column brand names and the reagents used to describe the stationary phases used with these columns, an overall review of all the monographs concerned has been undertaken. The names of the reagents and their definitions have also been reviewed to ensure that these stationary phases are described as clearly and consistently as possible.
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Ph.Eur. Supplement 9.4 available now
The 9.4 supplement of European Pharmacopoeia is now available and will be applicable in 38 European countries as from 01 April 2018. Read more
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MHRA delivers guidance on human factors
In collaboration with key stakeholders, MHRA has produced guidance on the human factors aspects of design for medical devices including those in drug-device combination products. Read more
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European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance
Updated guidance. Read more
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Commission Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use
Read more
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FDA approves first biosimilar for the treatment of cancer
The U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. Read more
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How to become a QP in Europe
Both the ECA and the European QP Association are often contacted by people who would like to become a Qualified Person in a Member State of the European Union or outside the EU to release products for the EU market. Here is what you need to know about becoming a Qualified Person. Read more
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Ordinance no. 270/2017 and Ordinance no. 271/2017 – National Official Journal no, 176/2017, Series I of 2017-09-12
Proceed to the first amendment, respectively, of: - Ordinance no. 195-A/2015, of June 30th, which approves the common procedure of the reimbursement and previous assessment of medicinal products; - Ordinance no. 195-B/2015, of June 30th, which regulates the determination of the homogeneous groups for purposes of the reimbursement in the reference prices system. Read more
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FDA Releases Draft Guidance on Child-Resistant Packaging
Drug companies must ensure their products meet federal standards for child-resistant packaging before labeling the packaging as child-resistant, the FDA said in draft guidance issued Aug. 2. Read more
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Test for Subvisible Particles: ICH Harmonisation Completed
With Step 5, harmonisation regarding the use of pharmacopoeial methods for test for subvisible particles in the ICH regions has been completed. Read more
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Implementation of the safety devices in the human use medicinal products
The requirement to place safety devices (device of prevention of adulterations and unique identifier) in the packages of certain medicinal products in order to allow the detection of falsified medicinal products in the legal circuit of the medicinal product and the individual identification of packages was introduced by Ordinance 2011/62/UE, Ordinance of the Falsified Medicinal Products and has to be implemented until 09 February 2019.
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Facilitating submission of post-approval data
The European Medicines Agency has launched a new form to help marketing authorisation holders submit data generated to satisfy post-authorisation measures (PAMs) for centrally authorised products. Read more
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Draft ICH S5 (R3) guideline on reproductive toxicology: detection of toxicity to reproduction for human pharmaceuticals, step 2b - Revision 3
Draft: consultation open Read more
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ICH Q4B - Harmonisation relating to the Sterility Test - General Chapters completed
The International Council for Harmonisation ICH Q4B - Harmonisation of pharmacopoeial chapters on Sterility Test with step 5 has now been finalized Read more
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Medical devices: EU regulations for MDR and IVDR
What you need to know about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR). Read more
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FDA Draws Up Blueprint for Pre-Approval Facility Reviews
The FDA has outlined plans for coordination between CDER and ORA in checking out the manufacturing facilities of drugmakers seeking approval for new pharmaceuticals. Read more
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Apply for manufacturer or wholesaler of medicines licences
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines. Read more
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Revised Ph. Eur. Chapter Tablets
Recently, the revised PH. Eur. Monograph Tablets (0478) has been published in Ph. Eur. Supplement 9.3. Read more
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Strengthening EU-US cooperation in medicine inspections
The European Commission (EC), the United States (US) Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have signed a new confidentiality commitment that allows the Us regulator to share non-public and commercially confidential information, including trade secret information relating to medicine inspections with EU regulators. This confidentiality commitment is a milestone in the ongoing implementation of the mutual recognition of inspections of medicine manufacturers and it aims to strengthen the EU-US relationship. Ultimately it will contribute to a more efficient use of inspection resources by regulators for the protection of human and animal health. Read more
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News questions and answers about safety features - Version 7 of the EU Q&As published
The soon-to-be mandatory safety features for the implementation of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The European Commission has published Version 7 of the questions and answers about safety features in June 2017. Read more
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FDA’s Expedited Programs Predict Better Drugs, But Companies Are Still Slow to Confirm Benefits, Researchers Say
The FDA has largely succeeded in expediting the review of drugs with larger health gains, but postmarket trials by companies have fallen behind in confirming some of those benefits, with many not using the gold standard of randomized controlled trials, according to two independent studies. Read more
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Monthly report on application procedures guidelines and related documents for veterinary medicines: July 2017
This report, which is updated every month, provides current information related to the volume and evaluation of pre and post-authorisation applications for medicinal products for veterinary use received by the European Medicines Agency. Read more
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What's new in pharmacovigilance - QPPV Update - Issue 2 - 2017
Information on recent developments in EU Pharmacovigilance, relating to medicines for human use, and includes updates on the EU network activities and relevant projects. Read more
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Annual report of the Pharmacovigilance Inspectors Working Group for 2016
This document is the ninth annual report of the Pharmacovigilance Inspectors Working Group. Read more
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New product information wording: extracts from PRAC recommendations on signals adopted at the 3-6 July 2017 PRAC
The product information wording in this document is extracted from the document entitled "PRAC recommendations on signals" which contains the whole text of the PRAC recommendations for product information update, as well as some general guidance on the handling of signals. Read more
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Update - CMDh Best Practice Guide on the use of eCTD in the MRP/DCP
Track version. Read more
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Transparency and data quality: new cross-cutting EFSA guidance in a nutshell
Two new guidance documents - on the weight-of-evidence approach and biological relevance assessment - will help to further harmonise methodologies across the areas in which EFSA works. Read more
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Questions and answers on production of water for injections by non-distillation methods – reverse osmosis and biofilms and control strategies
Read more
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USP monograph <1790>
The long-awaited new monograph <1790> of the US Pharmacopoeia about the visual inspection of injections, which is supposed to be an explanation for the already valid chapter <790>, will finally come into force on August, 1st. Read more
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IUCLID Cloud launched – simpler for smaller companies
The cloud version of the chemical data management tool IUCLID is now available for SMEs. Consultants helping SMEs with their registrations are welcome to subscribe too. In the cloud, you can prepare your REACH registration dossier directly online so there is no need for local installation. Reap the benefits of the cloud: data stored and safe at ECHA, automatic updates of IUCLID, fully managed back-ups, 24/7 availability of service. Read more
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Q&As on impact of EU-USA mutual recognition agreement on marketing authorisation applications and relevant variations
Read more
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API starting materials: EMA publishes updated reflection paper
In the recently published updated EMA reflection paper about starting materials, the passage about description of the manufacturing process of an API in an authorisation dossier has been revised. Read more
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Revised guideline on first-in-human clinical trials
The European Medicines Agency (EMA) has revised its guidance on first-in-human clinical trials to further help stakeholders identify and mitigate risks for trial partcipants. Read more
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 July 2017
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines for approval at its July meeting. Read more
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Ph. Eur. Supplement 9.3
Supplement 9.3 of the Ph. Eur. is now available. CEP holders are invited to update their applications according to the revised monographs that will be implemented on the 1st of January 2018, and to follow the instructions given in the document HERE. Read more
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Mutual recognition agreements
The European Union (EU) has signed mutual recognition agreements (MRAs) with third-country authorities concerning the conformity assessment of regulated products. Such agreements contain a sectoral annex on the mutual recognition of good manufacturing practice (GMP) inspections and batch certification of human and veterinary medicines. Read more
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EMA's updated Implementation Plan for the Introduction of Safety Features
The soon-to-be required safety features for the execution of the Falsified Medicines Directive have to be implemented by February 9th, 2019. The EMA has published an updated plan for the implementation of safety features on the packaging of centrally authorized products for human use. Read more
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Order no. 6289/2017 - National Official Journal no. 137/2017, Series II of 2017-07-18
Amends no. 4 of Order no. 5657/2017, published in National Official Journal, 2nd series, no. 123, of 28 June (clarifies the scope of application and establishes a quick and transparent procedure regarding the authorization applications underlying the provisions of article 9 of Decree-Law no. 5/2017, of 6 January). Read more
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Regulatory information – EMA improves its guidance for post-authorisation activities
The European Medicines Agency (EMA) has updated its best practice guidelines and support documents for marketing authorisation holders (MAHs) in the areas of type II variations, post-authorisation safety studies and changes related to quality aspects. Read more
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Questions and answers of scientific guidelineImproving the understanding of normal operating range (NOR), proven acceptable range (PAR), design space (DSp) and normal variability of process parameters. Read more
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What is GMP compliant Equipment Design?
It's frequent question what GMP compliant equipment design is or how a system has to be made up in order to be GMP compliant and suitable for the manufacturing of medicinal products/APIs. There is a short and a long answer to these questions around GMP compliant equipment design. Read more
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European Union individual case safety report (ICSR) implementation guide
This guidance specifies the technical requirements and the process of transmission of Individual Case Safety Reports (ICSRs) and is applicable to all stakeholders, which are exchanging ICSRs electronically within the EEA. Read more
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New tools to potentially reduce need for animal testing
EFSA recently launched its OpenFoodTox database of chemical hazards in food and feed. The database is a rich source of toxicological information for risk assessment that can potentially support the reduction of animal testing. Read more
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The launch of the new EudraVigilance system
This document addresses questions received from stakeholders in preparation of the launch of the new EudraVigilance System, which is to go-live on 22 November 2017. Read more
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Data on medicines (ISO IDMP standards)
The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). Read more
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Targeted stakeholder consultation on the experience acquired with the Paediatric Regulation
Results of the public consultation on the Paediatric Regulation are now available. Read more
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EMA and EUnetHTA step up interaction to align data requirements
The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) are stepping up their efforts to provide developers of medicines with simultaneous, coordinated advice on their development plans and facilitate alignment of data requirements. Read more
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Pharmeuropa: Texts for comments
Pharmeuropa issue 29.3 is now complete. Submit your comments before 30 September 2017. Read more
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Pre-submission checklist for type II variation applications
The Agency strongly recommends that this checklist is used in advance of submission of type II variation applications. You should be able to answer "Yes" to every item listed below unless a specific point is not applicable ("n/a") to the application in question. Please note that this checklist should not be included in the submission. Read more
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Decree-Law no. 5/2017, of 6 January – article 9 Establishments, Services and Bodies of the NHS and of the Ministry of Health and Communications Platform – Transparency and Advertising
Decree-Law no. 5/2017, of 6 January, which approves the general principles of advertising to medicinal products and medical devices, establishes specific rules regarding the scientific actions to be performed in establishments, services and bodies of the National Health System (NHS) and of the Ministry of Health (MH) and to the reception of support and benefits from these entities, as well as it also does some changes in the regimen of obligations of communications foreseen in article 159 of the Portuguese Medicinal Products Statute, approved by Decree-Law no. 176/2006, of 30 August, and in article 52 in Decree-Law no. 145/2009, of 17 June, recently become effective. Read more
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The MEDICRIME Convention in a few words
The EDQM plays a major role in implementing and monitoring the Council of Europe Convention on falsified medical products and similar crimes involving threats to public health, known as the MEDICRIME Convention. Read more
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EDQM publishes its 2016 Annual Report
The EDQM has just published its 2016 Annual Report. The report is an opportunity to review the different activities of the past year and reflect on what the EDQM accomplished and developed. In her foreword, EDQM Director, Dr Susanne Keitel, comments on the year's events, achievements, and thanks all involved for their dedication, expertise and support. Read more
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The user manual of EudraVigilance Web reporting tool EVWEB (version 1.0) is now available
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Two new medicines recommended for the treatment of chronic hepatitis C
The European Medicines Agency has recommended granting marketing authorisations in the European Union (EU) for Maviret and Vosevi, two new medicines indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults. Read more
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FDA Pediatric Cancer Panel Suggests More International Research Collaboration
In the second day of a two-day meeting, an FDA pediatric cancer advisory panel suggested further international cooperation and emphasized the need for tailoring trials to their specific diseases, while recommending against the use of placebos in pediatric cancer drug trials. Read more
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ICH M7(R1) Addendum reaches Step 4 of the ICH Process
The ICH M7(R1) Addendum reached Step 4 of the ICH process in May 2017 and now enters into the implementation period (Step 5). Read more
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Implementation of the Falsified Medicines Directive
Version 7 of "Questions and Answers" document regarding the implementation of the rules on the safety features for medicinal products for human use is now available. Read more
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Pharmacovigilance Legislation
The Q&A on the Pharmacovigilance legislation have been updated. Please find it in the track version of the document in force. Read more
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European Medicines Agency’s interaction with industry stakeholders - Annual report 2016
Read more
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SCCS - Request for a scientific opinion
Submission II on the safety of Butylphenyl methylpropional (p-BMHCA) in cosmetic products. Read more
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Applications pilot: dedicated support for small and medium-sized enterprises
EFSA has launched a new support initiative for applicants from small and medium-sized enterprises (SMEs). In the next six month, SMEs in the areas of feed additives and novel foods (excluding traditional food) can request an administrative check of their draft dossiers prior to submission. The support will be provided via teleconferences. Read more
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REACH tests need to comply with good laboratory practice
ECHA reminds registrants that all toxicological and ecotoxicology tests need to be carried out in compliance with good laboratory practice (GLP). Read more
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Concept paper on the need for the development of a reflection paper on regulatory requirements for the development of medicinal products for chronic non-infectious liver diseases (PBC, PSC, NASH)
Draft: consultation open Read more
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Regulatory guidance for industry to prepare for the UK’s withdrawal from the EU
The European Medicines Agency (EMA) and the European have published guidance to help pharmaceutical companies to prepare for the United Kingdom´s withdrawal from the European Union. The guidance relates to both human and veterinary medicines. Read more
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Substance not in the review programme? Check if you can still use it
A list of those active substances not covered by the review programme that can continue to be used in biocidal products is now available. Read more
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Simplex + 2016 Program
Infarmed has implemented 9 measures within the scope of the Simplex + 2016 Program. Read more
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Drugmakers Seek Clarifications of FDA’s Interchangeability GuidanceMore drugmakers have weighed in on the FDA´s draft guidance on biosimilar interchangeability, urging the agency to make clear the designation does not mean a product is superior in terms of safety or efficacy. Read more
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Medicines: apply for a parallel import licence
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application. Read more
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Decide if your product is a medicine or a medical device
How the Medicines and Healthcare products Regulatory Agency (MHRA) makes decisions on what is a medicine or medical device (borderline products). Read more
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European Pharmacopoeia: supplements 9.1 to 9.5 and new downloadable version available to order
Supplements 9.1 to 9.5 of the European Pharmacopoeia are now available to order on the EDQM store. These supplements, which are expected to be ready for dispatch during June, contain all the regulatory information that will come into force in the course of 2018. They complement the 9th Edition launched last year and bring the total number of monographs to 2351 (including dosage forms), along with 361 general texts (including general monographs and methods of analysis) and around 2670 descriptions of reagents. Read more
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EudraVigilance
EMA will launch a new EudraVigilance system with enhanced functionalities for reporting and analysing suspected adverse reactions in November 2017. Read more
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Chemistry of active substances (chemistry of new active substances)
This document describes the type of information required for the manufacture and control of active substances (existing or new chemical entities) used in a medicinal product. Effective from 21/05/2017. Read more
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May Newsletter published
In the May issue of the ECHA Newsletter, you can read expert views on how close we are to end animal testing, how safe artificial pitches are and how you can now find safer chemicals online. Read more
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EudraVigilance Data Analysis System (EVDAS)
User registration steps for EU QPPVs or trusted deputies (for the purpose of the EudraVigilance registration process). Read more
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency´s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Read more
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Report of the consultation - Public consultation on strengthening EU cooperation on Health Technology Assessment (HTA)
Read more
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Ordinance no. 111/2017 - National Official Journal No. 93/2017, Series II of 2017-05-15
Adds the annex to Ordinance no. 158/2014, of 21 February, which reviews the special reimbursement regimen for medicinal products meant for the treatment of the hepatitis C disease, adding the medicinal product containing the substance Sofosbuvir + Velpatasvir. Read more
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Progress on science, medicines and health
The European Medicines Agency's (EMA) 2016 annual report focuses on the Agency's key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and the safety monitoring of medicines in real life. Read more
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Nitrogen Use in pharmaceutical Production
Nitrogen often comes in contact with a product during manufacturing and is therefore relevant for its quality, especially when it comes to the manufacture of sterile products. Nonetheless, the use of nitrogen is significantly less specified than that of pharmaceutical water. Parameters and limits have to be defined by the pharmaceutical users themselves. Read more
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Press Release – Ministers of six countries sign unprecedented agreement for access to medicinal products
The Ministers of Health of six European countries, including the Minister of Health Adalberto Campos Fernandes, signed yesterday the La Valletta Declaration, an unprecedented agreement that aims to ensure patient access to innovative medicinal products and, at the same time, the sustainability of the healthcare systems. Read more
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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices
Amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Read more
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Now Official: Revised USP Plastic Packaging Chapters <661.1> and <661.2>
The USP Expert Committee General Chapters - Packaging and Distribution posted on April 28, 2017, the previously announced Revision Bulletins, Postponement, regarding general chapters <659>, <661>, <661.1> and <661.2>. The revisions of the four general chapters have become official on May 1, 2017. Read more
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Draft Addendum of the ‘ICH E11(R1) guideline on clinical investigation of medicinal products in the paediatric population’ (EMA/CPMP/ICH/2711/1999)
Overview of comments received by the European Medicines Agency Read more
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Drug Safety Update: monthly newsletter
Monthly PDF editions of the
Drug Safety Update newsletter from MHRA and its independent advisor the
Commission on Human Medicines.
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Instruction document of the Spanish Agency for Medicinal Products and Medical Devices for conducting clinical trials in Spain
In this instruction document of the Spanish Agency of Medicinal Products and Medical Devices for conducting clinical trials in Spain is provided, in a questions and answers format, information on the practical aspects that entail the application of the Royal Decree 1090/2015, of 4 December, highlighting the differences concerning the previous royal decree. Read more
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PUBLISHING OF THE GLOBAL STATISTIC DATA OF THE YEAR 2016 (RESULTS ON 31/12/2016)
The global statistic data of the year 2016 (results on 31/12/2016) are published, available in the spacer Indicators CEIC. The indicators regarding Clinical Trials with Medicinal Products, Clinical Trials with Intervention of Medical Devices and Financial Contracts of Studies approved by CEIC are available. Read more
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Draft guideline on good clinical practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials
Draft: consultation open Read more
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What's new in Pharmacovigilance - QPPV Update - Issue 1 - 2017
This is the first issue of QPPV Update in 2017. It provides Qualified Persons responsible for Pharmacovigilance (QPPVs) and all other people working in pharmacovigilance with an update on EU Pharmacovigilance. Read more
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Position (EU) No 2/2017 of the Council at first reading
Adoption of a Regulation of the European Parliament and of the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC Read more
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FDA approves two hepatitis C drugs for pediatric patients
The U.S. Food and Drug Administration approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Solvaldi were previously approved to treat HCV in adults. Read more
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Optimising safety information for medicines in Europe throughout product lifecycle
Following two years of experience with safety monitoring of nationally authorised medicines via the single assessment of periodic safety update reports (PSURs), the European Medicines Agency (EMA) has issued additional guidance and recommendations as part of its commitment to continuous process improvement. Read more
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EMA revises Guide on Pharmaceutical Water
According to the European Pharmacopoeia, it is allowed as of the 1st of April 2017 to produce water for injection (WFI) using cold i.e. non-distillation methods. Now, the European Medicines Agency EMA has published a concept paper on the revision of the "Note for Guidance on Quality of water for pharmaceutical use". Read more
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PRAC recommendations on signals adopted at the PRAC meeting of 6-9 March 2017
Adopted Read more
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CMDh Best Practice Guidance on collaboration between Member States in relation to serious GMP non-compliance issues
The aim of this Best Practice guide is to facilitate the collaboration among MSs in the Coordination Group for Mutual Recognition and Decentralised Procedure (human), CMDh, on serious GMP issues notified to the group. Read more
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Good pharmacovigilance practices
Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level. Read more
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CMDh procedural advice on changing the RMS
In exceptional circunstances, a Marketing Authorisation Holder (MAH) may request a change of the Reference Member State (RMS). Read more
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EMA Q&A on GCP
The European Medicines Agency (EMA) recently published Questions and Answers on good clinical practice (GCP) on its website. Read more
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Scientific guidelines with summary-of-product-characteristics recommendations
Update Read more
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COMMISSION IMPLEMENTING REGULATION (EU) 2017/556, of 24 March 2017, on the detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of the European Parliament and of the Council
Text with EEA relevance Read more
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Use of big data to improve human and animal health
Together with the heads of the national competent authorities in the European Economic Area (EEA), known as Heads of Medicines Agencies (HMA), the European Medicines Agency (EMA) has established a new task force to explore how medicines regulators in the EEA can use big data to support research, innovation and robust medicines development in order to benefit human and animal health. Read more
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New portal “Information System for the Assessment of the Health Technologies – SIATS”
As from today, 23rd March, the new SIATS (Information System for the Assessment of the Health Technologies) portal is available, which will allow the MA holders and their representatives to manage the medicinal products accessibility. Read more
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Annex 16 QP Certification: important Questions and Answers
What can a Supply Chain Diagram look like? How to rely on vendor-supplied samples? These are just two examples of questions being frequently asked in connection with the new Annex 16 of the EU-GMP Guidelines (Certification by a Qualified Person and Batch Release). Read more
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Agenda - CHMP agenda of the 20-23 March 2017
Draft agenda for the meeting on 20-23 March 2017 Read more
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2016 annual report on EudraVigilance for the European Parliament, the Council and the Commission
This Annual report is prepared in accordance with EU legislation and summarises the EudraVigilance related activities performed in 2016. Read more
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Quality of medicines questions and answers: Part 1
These questions and answers address a number of questions that have been brought to the attention of the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have been developed and are maintained by the QWP. Read more
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Launch of SPOR data management services
The European Medicines Agency (EMA) is preparing data management services in the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) data. The SPOR services will support the implementation of the standards developed by the International Organization for Standardization (ISO) for the identification for medicinal products (IDMP). Read more
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EMA Paper on Dissolution Specification for Generic Products published
The EMA published the draft of the "Reflection paper on the dissolution specification for generic oral immediate release products". Read more
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Variations to the terms of MA: National Procedure
Frequently Asked Questions - National Variations Read more
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Regulatory cooperation to improve global health
How to improve the availability of high quality, safe and effective medicines to patients in countries beyond Europe and how to make better use of existing tools? These were two of the questions discussed at a workshop jointly organised by the European Medicines Agency (EMA) and the Maltese Presidency of the European Union (EU) that brought together regulators from across the EU and Africa in Malta on 2 and 3 March 2017. Read more
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EC Report Recommends Policy Actions on Off-Label Use
Regulations on off-label use are not harmonized across the European Union - only 10 out of 21 surveyed member states have specific policies, according to a European Commission report Read more
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Implementation strategy of ICH Q3D guideline
The purpose of this document is to address specific considerations to enable the practical implementation of ICH Q3D Guideline for Elemental Impurities in the European Union. Read more
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Sterile plastic containers for human blood and blood components
A draft of Ph. Eur. chapter 3.2.3 Sterile plastic containers for human blood and blood components has been published for comments in Pharmeuropa 29.2. Deadline for comments is June 30, 2017. Read more
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Concept paper on the need for revision of note for guidance on quality of water for pharmaceutical use (H+V)
Draft: consultation open Read more
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CEIC Guideline on the SUPPLY OF THE MEDICAL DEVICE IN THE SCOPE OF CLINICAL STUDIES WITH INTERVENTION
In the CEIC website, in the spacer Guidelines the CEIC Guideline on the SUPPLY OF THE MEDICAL DEVICE IN THE SCOPE OF CLINICAL STUDIES WITH INTERVENTION is published. This document was approved in plenary meeting on 20th February and published on 24th February. Read more
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Mutual recognition with the United States
Authorities in the European Union (EU) and the United States (US) have put in place a mutual recognition agreement (MRA) on good manufacturing practice (GMP) inspections. The aim of the agreement is to encourage greater international harmonisation, make better use of inspection capacity and reduce duplication. Read more
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PRIME: priority medicines
PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. Read more
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Delegate Regulation on the Anti-Counterfeiting Directive
New EU Requirements and State of Implementation
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Adaptive Pathways
Report on a meeting with stakeholders held at EMA on Thursday 8 December 2016. Read more
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Best Practice Guide on the Assessment Report for Mutual Recognition and Decentralised Procedures
Update Read more
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New downloadable version of the European Pharmacopoeia
With the publication of Supplement 9.3 the USB version of Ph.Eur. will be replaced by a downloadable version. Read more
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The ICH Q11 draft Q&A presentation available now on the ICH website
The ICH Q11 Questions and Answers (Q&As) on the Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities), regarding the selection and justification of starting materials, reached Step 2b of the ICH Process in November 2016 and now enters the consultation period. A training presentation has also been developed by the expert Working Group. Read more
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Questions and answers: Good manufacturing practice
European Medicines Agency´s answers to frequently asked questions, as discussed and agreed by the Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group (Update). Read more
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Concept paper on developing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product
Draft: consultation open Read more
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EDQM on biosimilars: Ph. Eur. monographs are flexible and evolving standards
During a seminar coorganised with the European Medicines Agency (EMA), the EDQM clarified further the role that Ph. Eur. monographs play in the assessment of biosimilars. As public standards for the quality of medicines in Europe, monographs ensure the quality of biosimilar and other biotherapeutic products, but compliance with them is not sufficient for demonstrating biosimilarity. However, while Ph. Eur. monographs provide specifications in the form of tests and acceptance criteria for all medicines, they are dynamic documents that can be adapted to scientific progress. Read more
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Ordinance no. 1542/2017 – National Official Journal no. 33/2017, Series II of 2017-02-15
Defines the concept of "insignificant valuables and relevant for the practice of the healthcare professional " providing its uniform fixation, in the scope of the sectors of the medicinal product and of the medical devices. Read more
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Revised document published on Management of applications for new CEPs and revisions/renewals of CEPs.
The document PA/PH/CEP (13) 110 which described the policy for assessment of CEP applications has been revised following a review of current practice. Read more
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Press Release – Europe begins safety assessment of quinolones (antibiotics)
The European Medicines Agency (EMA) began the safety review of the quinolones and fluoroquinolones, which are broad spectrum antibiotics used in the treatment of severe bacterial infections. The purpose of this review - which originated a newsletter published at Infarmed´s website - is to assess the duration of severe adverse reactions that affect the muscles, the joints and the nervous system. Read more
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New MedRegs blog
MHRA has launched an official blog providing expert insight into the latest regulatory thinking and all aspects of medicines regulation. Read more
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Annual report on the use of the special contribution for orphan medicinal products
Patients suffering from rare diseases deserve access to the same quality of medicinal products as other patients within the European Union (EU). The incentives laid down in the orphan legislation aim to simulate sponsors to develop medicinal products for rare diseases. Medicinal products eligible for incentives are identified throught the EU procedure of orphan designation. The orphan designations cover a wide variety of rare diseases, including genetic diseases and rare cancers, for which there are limited treatment options, a large number of these diseases also affect children. Read more
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Support for applications on Article 58
EMA has in place a range of regulatory tools to support applicants in the development and submission of applications for medicinal products relevant to Article 58. Read more
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Agenda - Pharmacovigilance Risk Assessment Committee (PRAC)
Draft agenda for the meeting on 6-9 February 2017 Read more
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Guideline on core SmPC and Package Leaflet for nanocolloidal technetium (99mTc) albumin - First version
Adopted Read more
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Summaries of scientific recommendations on classification of advanced therapy medicinal products
The European Medicines Agency´s Committee for Advanced Therapies delivers scientific recommendations on whether a medicine can be classified as an advanced therapy medicinal product (ATMP). The Agency publishes the outcomes of these assessements in the format of summary reports. Read more
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Clinical data for two more medicines now available online
The European Medicines Agency (EMA) has published clinical data for two additional medicines on its clinical data website. This follows the launch of the website on 20 October 2016 and is in line with the Agency's policy on the publication of clinical data. Read more
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Elemental Impurities: The Next Steps for the Implementation of ICH Q3D into the European Pharmacopoeia
The EDQM has published the next steps for the implementation of the ICH Q3D guideline in the European Pharmacopoeia. Read more
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Transparency platform – Specific rules for the establishments, services and organisms of the NHS and of the Ministry of Health (Decree-Law no. 5/2017, of 6 January – Article 9)
Decree-Law no. 5/2017 approves the general principles of the advertising to medicinal products and medical devices.
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 January 2017
The European Medicines Agency´s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its January meeting. Read more
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Post-orphan medicinal product designation procedures: guidance for sponsors
The opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA). Read more
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Medicine evaluation figures
The European Medicines Agency (EMA) publishes information on the volume and outcome of marketing authorisation and post-authorisation applications for human and veterinary medicines that it evaluates. Read more
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GMP Outlook for 2017 (Part 2)
There are many new developments and change notifications in the GMP area kepping the pharmaceutical industry busy, not least because many of the new requirements must be implemented soon. Read more
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The M4(R4) presentation available now on the ICH Website
The Common Technical Document (CTD) is organised into five modules, including as an Annex the Granularity document that provides guidance on document location and paginations. In June 2016, this Annex was revised to add Module 2 and 3 tables and Appendices for eCTD v4, as well as, corrections to Module 2 and 3 tables for eCTD v3.2.2. Read more
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Update of application forms “Request for new CEP” and “Request for revision or renewal of CEP”
The application forms for the submission of new Certificate of Suitability applications and for requests for revision or renewal have been slightly revised in order to remove the reference to the EDQM Dropbox and submission of CD-ROM/DVD. Applicants should use the CESP (Common European Submission Portal) to submit documentation to EDQM. Read more
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The Q3C(R6) Step 4 presentation available now on the ICH Website
The Q3C Guideline recommends the use of less toxic solvents in the manufacture of drug substances and dosage forms, and sets pharmaceutical limits for residual solvents (organic volatile impurities) in drug products. Read more
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Good manufacturing practice and good distribution practice
Comply with good manufacturing practice (GMP) and good distribution pratice (GDP), and prepare for an inspection. Read more
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Revised USP Chapter on Analytical Instrument Qualification
The USP has released a revision of Chapter on Analytical Instrument Qualification. This chapter set the fundamental requirements on the qualification of different types of instruments in the laboratory. Read more
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Update on the Ph. Eur. policy on elemental impurities
With the implementation of the ICH Q3D guideline on elemental impurities, the control of elemental impurities is undergoing a shift in paradigm, moving away from pure substance-based testing towards a holistic control strategy in the finished product. While these approaches are not contradictory, this change has triggered the revision of numerous texts in the European Pharmacopoeia (Ph. Eur.). Read more
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Human medicines highlights - January 2017
This newsletter provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency. Read more
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GMP Update - what was new in 2016?
"You get the impression that GMP is developing faster and faster". During the past year, the world of GMP turned somethat slower. Its developments in the GMP environment remain interesting though. Read more
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ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6
ICH is inviting public review and comment on a reflection paper on Good Clinical Pratice (GCP) "Renovation", which contains the ICH proposal for further modernization of the ICH Guidelines related to clinical trial design, planning, management, and conduct. Read more
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IMDRF publishes Guidance Draft on Clinical Studies with Software as a Medical Device
The IMDRF (International Medical Devices Regulator Forum) is the sucessor organisation of the Global Harmonisation Task Force (GHTF). Recently, the IMDRF has published a guidance draft entitled "Software as a medical Device (SAMD): Clinical Evaluation". Read more
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Setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
Update Read more
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New Chapter on Chemical Imaging in the Ph. Eur.
The chapter on Chemical Imaging (5.24) was adopted by the European Pharmacopoeia Commission at the end of November 2016. The Vibrational Spectroscopy and Analytical Data Modelling working party (VSADM) has produced the first such chapter to be included in any pharmacopoeia worldwide. This general chapter is intended to further the use of Chemical Imaging (CI) for analysing pharmaceutical products in formulation and analytical development, quality control and manufacturing environments. The final text will be published in Supplement 9.3 in July 2017. Read more
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Decree-Law no. 5/2017 – National Official Journal no. 5/2017, Series I of 2017-01-06
Approves the general principles of the advertising to medicinal products and medical devices. Read more
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PRAC recommendations on signals adopted at the PRAC meeting of 28 November-1 December 2016
Adopted Read more
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FAQ VALIDATION – CHANGE OF PRINCIPAL INVESTIGATOR
A new validation FAQ is published, regarding the change of principal investigator. Read more
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FDA Clarifies Scope of Major Deficiencies in ANDA Refuse-to-Receive Guidance
The FDA has again updated on its criteria for refusing to receive an ANDA, providing a broader definition for major deficiencies and downgrading four major deficiencies to minor ones in order to make requirements less burdensome for industry. Read more
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FDA Tweaks Guidance on Clinical Pharmacology Data for Demonstrating Biosimilarity
The FDA has made modest changes to its guidance on clinical pharmacology testing for biosimilars. Read more
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Direct action antiviral (hepatitis C) – final recommendations
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed the recommendations disclosed in Newsletter no. 167/CD/550.20.001, of 05/12/2016. Read more
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Order no. 16029/2016 – National Official Journal no. 246/2016, Series II of 2016-12-26
Public consultation on the Regulation variation Project regarding Prior Notice of Medicinal Product Transactions Abroad. Read more
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Revision of PIC/S GMP Guide (PE 009-13)
Chapters 1, 2, 3, 6 & 7 of the PIC/S GMP Guide have been revised. Read more
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Ordinance no. 331/2016 - National Official Journal no. 244/2016, Series I of 2016-12-22
Establishes an exceptional reimbursement regimen for the medicinal products intended for the treatment of moderate to severe oncological pain. Read more
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Sistema de Preços de Referência - 1.º trimestre de 2017
A lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 1º trimestre de 2017 foi aprovada pela deliberação nº 77/CD/2016, de 19 de dezembro de 2016 do Conselho Directivo e entra em vigor a 1 de janeiro de 2017. Read more
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency´s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Read more
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016
The European Medicines Agency´s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for marketing authorisation at its December 2016 meeting. This brings the total number of medicines recommended for approval by the CHMP in 2016 to 81. Read more
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use guideline Q3C (R6) on impurities: guideline for residual solvents - Step 5
This document recommends acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. It recommends use of less toxic solvents and describes levels considered to be toxicologically acceptable for some residual solvents. Read more
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API-mix and CEPs
EDQM has published the document "API-Mix (or mixtures) and CEPs" with regards to the acceptance of applications for CEPs where associated monograph of the European Pharmacopeia is for a mixture of an API and excipient. This clarifies the acceptability of such applications in line with the EMA Q&A on this subject which is referenced in the documnet. In addition it provides some clarification on information to be provided in the application and the information ehich will be included on the CEP for such substances. Read more
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EMA hosts workshop on adaptive pathways
The European Medicines Agency (EMA) has hosted a workshop with stakeholders to discuss adaptive pathways, an approach to medicines development that aims to facilitate access to medicines that address patients' unmet needs. Read more
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FDA Perspective on Risk Management and its Influence on Quality - Inspection Deficiencies 2015
In the framework of a conference on Quality and Manufacturing, David J. Jaworski, Senior Policy Advisor of CDER´s Office of Manufacturing and Product Quality gave a presentation on risk management and its influence on quality. The slides of his presentation are now freely available. Read more
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Human medicines highlights - November 2016
This newsletter provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency. Read more
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Selection and justification of starting materials: new Questions and Answers to ICH Q11 published
The ICH Q11 Guideline describing approaches to developing and understanding the manufacturing process of drug substances was finalised in May 2012. Since then the pharmaceutical industry and the drug substance manufacturers had time to get familiar with the principles outlined in this guideline. However, experience has shown that there is some need for clarification. Thus the Q11 Implementation Working Group recently issued a Questions and Answers Document. Read more
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New monograph on sodium pertechnetate (99mTc) injection (accelerator-produced) adopted
At its 156th Session the European Pharmacopeia Commission adopted the monograph on Sodium pertechnetate (99mTc) (accelerator-produced) injection (2891). Read more
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Implementation of ISO IDMP standards - Update
The European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for Standardization (ISO) for the identification of medicinal products (IDMP). Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies. Read more
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Highlights 156th session of the Ph. Eur. Commission
Fourteen new texts and 52 revised monographs were adopted and the Ph. Eur. implementation strategy of the ICH Q3D guideline on elemental impurities was fine tuned. Read more
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Evaluation of the EMA fee system – terms of reference for external contract.
DG SANTE has contracted out a study to support the evaluation of the fee system of the European Medicines Agency. The project will start in December 2016 and will last for 15 months. Read more
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Active pharmaceutical ingredients: Japan joins international collaboration on GMP inspections
The ongoing collaboration on good manufacturing practice (GMP) inspections of active-pharmaceutical-ingredient (API) manufacturers between the European Medicines Agency (EMA) and its international partners is to be expanded to include Japan´s Pharmaceutical and Medical Devices Agency (PMDA). Read more
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ORDER NO. 14202A/2016 – NATIONAL OFFICIAL JOURNAL NO. 227/2016, 1st SUPPLEMENT, SERIES II OF 2016-11-25
Under the scope of the National Programme for Prevention and Control of Smoking and of the Programme-type of action in Stopping Smoking, from the Directorate-General of Health, until the end of the year 2016 and during the year 2017, priority is given to the acess to nicotine-replacement medicinal products and to the reimbursement of the anti-smoking medicinal products subject to medical prescription. Read more
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Non-animal methods now a default for skin sensitisation – submit correct information
The new REACH requirements for skin sensitisation entered into force on 11 October 2016 making non-animal testing the default requirement. Remember to take this change into account when submitting information to ECHA, otherwise your dossier will not pass the completeness check. Read more
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Pharmacopoeial Discussion Group (PDG) Achievements
The meeting of the Pharmacopoeial Discussion Group (PDG) [European Pharmacopoeia (Ph. Eur.), Japanese Pharmacopoeia (JP), and the United States Pharmacopeia (USP)] was hosted by JP in Tokyo, Japan, 24-26 October 2016. To date, 30 of the 36 General Chapters and 49 of the 67 excipient monographs on the current work programme have been harmonised. Sign-offs at this meeting include a new general chapter on Colour (Instrumental method) and a revised general chapter on Amino Acid Determination. Read more
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Guideline on the chemistry of active substances
This guideline replaces "Note for guidance on chemistry of new active substances" (CPMP/QWP/130/96, Rev 1) and "Chemistry of active substances" (3AQ5a). Read more
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Regulatory information – New guidance on type II variations and marketing authorisation extensions for orphan-designated medicines
The European Medicines Agency (EMA) has updated its post-authorisation guidance on extensions of marketing authorisations and type II variations to include further details on the information companies need to provide when submitting a type II variation or a marketing authorisation extension for an orphan-designated medicine. Read more
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RNEC – New way of electronic submission, registration and disclosure of clinical studies
The electronic platform for registration and disclosure of clinical studies - National Register of Clinical Studies - RNEC, will be available from 5th December 2016 and will allow, at this stage, the electronic submission of the following clinical studies regarding areas regulated by Infarmed: Clinical trials with medicinal products for human use; Clinical studies with intervention of medical devices; Clinical studies with intervention of cosmetic products; Post-Authorisation Efficacy Studies (PAES) with no intervention; Post-Authorisation Safety Studies (PASS) with no intervention. Read more
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Enpr-EMA awareness webinar
European Medicines Agency, London, UK, From: 01-Dec-2016, To: 01-Dec-2016. This webinar aims to showcase to pharmaceutical companies the benefits of working with the European Network for Paediatric Research at EMA (Enpr-EMA) and the clinical research networks it represents in the development of medicines for children. Read more
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Ordinance no. 290-B/2016 - NATIONAL OFFICIAL JOURNAL no. 219/2016, 1st Supplement, Series I of 2016-11-15
Defines the reference countries, to be considered in 2017, for the authorization of the new medicinal products prices and for purposes of annual prices revision of the hospital market and of the ambulatory market and introduces an exceptional criterion to be applied in the prices revision system and its suspension for generic medicinal products. Read more
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. Read more
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 November 2016
The European Medicines Agency´s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval at its November meeting. Read more
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Update of Chesar 3 supports use maps
ECHA´s Chemical Safety Assessment and Reporting tool (Chesar) has been updated to support the use of sector-specific use maps directly in the tool. In addition, registrants can now generate their exposure scenarios for communication in a standardised ESCom XML format. Read more
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II Days of PPCIRA
The II Days of the Programme on Prevention and Control of Infection and Antimicrobial Resistance (PPCIRA) will take place in the World Antibiotic Awareness Week 2016, on the days 17th and 18th November, in the Tomé Pires Auditorium, at INFARMED. Read more
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The EDQM “Electronic submissions for CEP applications Roadmap 2016-2020” has been revised.
The EDQM roadmap for electronic submissions for CEP applications has been revised in order to align with the recently established HMA (Heads of Medicines Agencies) eSubmission Roadmap. For new CEP applications, eCTD format will become mandatory as of 1 January 2018, For revisions and renewal applications eCTD format will become mandatory as of 1 January 2020. TSE only submissions and submissions for substances for veterinary use only are exempt from this ruling. Read more
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European campaign: Report side effects makes the medicines safer
See the campaign in the "Campanhas" area Read more
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Order no. 13277/2016 - NATIONAL OFFICIAL JOURNAL no. 213/2016, Series II of 2016-11-07
It determines, in the scope of the National Programme for Diabetes, the development of the strategy of Access to Treatment with Devices of Continuous Subcutaneous Insulin Infusion (CSII), with the purpose of ensuring the coverage of all the population eligible in paediatric age until the year 2019. Read more
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Ordinance no. 284-A/2016 - NATIONAL OFFICIAL JOURNAL no. 212/2016, 1st Supplement, Series I of 2016-11-04
It does the third amendment to Ordinance no. 224/2015, of 27th July, in the wording resulting from Ordinances nos. 417/2015, of 4th December, and 138/2016, of 13th May, and to its republishing (It establishes the legal regimen to which comply the rules of prescription and dispense of medicinal products and health products and defines the obligations of information to provide to the users). Read more
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FDA Guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation"
To assist pharmaceutical manufacturers in the development, analysis, and presentation of microbiology data during antibacterial drug development, the FDA published a guideline on "Microbiology Data for Systemic Antibacterial Drugs - Development, Analysis, and Presentation". Read more
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Paediatric requirements for marketing-authorisation applications
Applications for marketing authorisation submitted to the European Medicines Agency (EMA) that concern medicines not authorised in the European Union (EU) on 26 July 2008 must include the results of studies carried out as part of an agreed paediatric investigation plan (PIP) or information on a PIP deferral or waiver. Read more
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New features in biocides IT tools
The biocides submission tool (R4BP 3) has been updated to support new features for Union authorisation and authorisation of same biocidal products. The tool for creating summaries of product characteristics (SPC Editor) now supports the creation of a biocidal product family with sub-families. Read more
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Annual Report of the GMP/GDP Inspectors Working Group published
EMA´s GMP/GDP Inspectors Working Group has published the 2015 annual report summarising its activities. Read more
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Regulatory update – EMA encourages companies to submit Type I variations for 2016 by end of November
The European Medicines Agency (EMA) is advising marketing authorisation holders to submit any Type IAIN and Type IA variations for 2016 by Wednesday 30 November. This will enable the Agency to acknowledge the validity of the submissions before the Agency´s closure between 23 December 2016 and 2 January 2017 within the 30-day timeframe set out in Article 14 of Commission Regulation (EC) No 1234/2008. Read more
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Commission launches public consultation on strengthening EU cooperation on Health Technology Assessment
Launch of public consultation on the Commision initiative for strenghening EU cooperation on health technology assessment (HTA). Read more
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Clinical data publication
As of October 2016, the European Medicines Agency (EMA) publishes clinical data submitted by pharmaceutical companies to support their regulatory applications for human medicines under the centralised procedure. This is based on EMA´s flagship policy on the publication of clinical data. Read more
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New ICH M9 Guideline in development on Biopharmaceutics Classification System (BCS)-based biowaivers
In October 2016, the ICH endorsed a new topic for the development of a new multidisciplinary guideline to address Biopharmaceutics Classification System (BCS)-based biowaivers. This guideline will provide recommendations to support the biopharmaceutics classification of medicinal products and will provide recommendations to support the waiver of bioequivalence studies. Read more
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Ph. Eur. Draft Chapter 3.2.1 "Glass containers for pharmaceutical use"
A draft of a revised version of Ph. Eur. General Chapter 3.2.1 "Glass Containers for Pharmaceutical Use" has been published in Pharmeuropa 28.4 Comments regarding this draft can be suvmitted until 31. December 2016. Read more
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Draft Guidance Outlines Procedure for Clinical Evaluation of Software as a Medical Device
The draft guidance addresses stand-alone software designed to produce or extract data. Read more
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 2016
The European Medicines Agency´s Committee for Medicinal Products for Human Use (CHMP) recommended eight medicines for approval at its October meeting. Read more
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ICH E11(R1) guideline on clinical investigation of medicinal products in the pediatric population: Step 2b
Draft: consultation open Read more
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FDA Adds Technical Requirements for Electronic Submission of Study Data
Before the end of the year, the FDA will begin requiring that study data for NDA, BLA, and ANDA submissions be submitted to the agency in a standardized electronic data format. Read more
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What are the GMP Responsibilities of the Marketing Authorisation Holders?
The GMP/GDP Inspectors Working Group of the European Medicines Agency (EMA) has published a concept paper to summarise the GMP responsibilities of the Marketing Authorisation Holders (MAH). Read more
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Agenda - CHMP agenda of the 10-13 October 2016
Draft agenda for the meeting on 10-13 October 2016 Read more
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Pre-submission checklist for 5-year renewal applications
The purpose of this checklist is facilitating submission of complete and correct 5-year Renewal Applications by marketing authorisation holders (MAHs). Read more
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Ordinance no. 262/2016 - NATIONAL OFFICIAL JOURNAL no. 193/2016, Series I of 2016-10-07
Regulates the specific compensation given to pharmacies due to dispense of reimbursed medicinal products, according to the reduction of the reference prices. Read more
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USP announced Major Revision of General Chapter
The United States Pharmacopeia (USP) Expert Committee on General Chapters - Dosage Forms announced a major revision of general chapter Tablet Breaking Force. Comments can be submitted until October 15, 2016. Read more
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EDQM enhances sharing of information with Japanese regulatory authorities and strengthens collaboration with Japanese Pharmacopoeia
The EDQM has agreed with the Japanese authorities to improve the sharing of information related to therapeutic products that are common to both Europe and Japan, and to strengthen collaboration between the European and Japanese Pharmacopeias. Read more
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 26-29 September 2016
During its monthly meeting, the European Medicines Agency´s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) focused on the broad spectrum of its responsibilities which cover all aspects of the risk management of the use of medicines. The committee did not initiate or conclude a referral. Read more
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Dossier requirements for referral, active substance master files (ASMF) and nationally authorised products (NAPs) submissions (PASS107, workshare, signal detection procedures) and ancillary medicinal substances in a medical device
Update Read more
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New MEDDEV Document on the Clinical Evaluation of Medical Devices
To put EU Medical Devices (93/42/EEC and 90/385/EEC) in concrete terms, the EU issues so-called MEDDEV documents. In this context, the document MEDDEV 2.7/1 revision 4 entitled "Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEV" has been newly published. Read more
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Ordinance no. 256/2016 - NATIONAL OFFICIAL JOURNAL no. 187/2016, Series I of 2016-09-28
Approves the principles and standards of good distribution practice of medical devices (listed in the annex) to be considered by the entities that exercise the activity of medical device wholesale distribution Read more
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Ordinance no. 255/2016 - NATIONAL OFFICIAL JOURNAL no. 186/2016, Series I of 2016-09-27
Amends the Ordinance no. 223/2015, of July 27 [Regulates the procedure of payment of the State reimbursement in the retail selling price (PVP) of the medicinal products made available to beneficiaries of the National Health Service (NHS) and of public subsystems that are the NHS responsibility, or that benefit from reimbursement in regime of complementary]. Read more
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Joint Newsletter no. 8/2016/ACSS/INFARMED/SPMS – update of health care goods and services that should be object of centralised acquisition
Please find the joint newsletter attached. Read more
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FDA Reviews Questions on ICH Guidance for Nonclinical Evaluation of Cancer Drugs
The FDA is taking public questions and comments relating to implementing a global guidance from 2010 on the nonclinical evaluation of anticancer drugs, also known as the S9 guidance, developed by the International Council for Harmonisation. Read more
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PRIME: priority medicines
PRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. Read more
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Task force for the implementation of International Standards on Identification of medicinal products in the EU (i.e. EU ISO IDMP task force)
Update Read more
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GVP Update
Eudralex Volume 9 - Guideline on good pharmacovigilance practices (GVP) now comprises several updates. Read more
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Inception Impact Assessment on Strengthening of the EU cooperation on Health Technology Assessment (HTA)
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September Newsletter gives practical advice to registrants
This issue includes useful advice to companies who are preparing their submissions for the REACH 2018 registration deadline and explains how ECHA checks the completeness of registration dossiers. We also look back on the past three years of the Biocidal Products Regulation and give an update on where we are today. In addition, you can read interviews with experts on substitution, socio-economic analysis and the circular economy. Read more
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Progress made in the operation of EU pharmacovigilance legislation
The European Medicines Agency (EMA) is organising the tenth stakeholder forum on the operation of the pharmacovigilance legislation on 21 September 2016. This is the latest in a series of events organised by EMA to review the progress made and to consult stakeholders on what needs to be the focus over the coming years. Read more
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Analytical Lifecycle: USP "Statistical Tools", Analytical Target Profile and Analytical Control Strategy
The United States Pharmacopeia (USP) is currently undertaking further steps towards a comprehensive analytical lifecycle approach by publishing a draft of a new General Chapter Statistical Tools for Procedure Validation and two Stimuli Articles regarding Analytical Target Profile and Analytical Control Strategy in Pharmacopeial Forum. Read more
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Application form for the involvement of industry stakeholder organisations in the activities of the European Medicines Agency (EMA)
Further to the adoption of the Framework for interaction between the European Medicines Agency and industry stakeholders in October 2015, this application form has been created of the Agency to evaluate whether a specific industry stakeholder organisation fulfils the elegibility criteria for involvement in the Agency´s activities. Read more
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Decree-Law no. 62/2016 - NATIONAL OFFICIAL JOURNAL no. 175/2016, Series I of 2016-09-12
It establishes the terms and conditions of the provision of intervention services in public health by the community pharmacies, as well as the possibility of awarding a specific compensation to the pharmacies due to dispense of reimbursed medicinal products, namely in the medicinal products inserted in homogeneous groups. Read more
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Advertise your medicines
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines. Read more
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Fighting antimicrobial resistance globally
Alignment of data requirements by regulators worldwide can contribute to stimulate the development of new antibiotics to fight antimicrobial resistance and protect global public health. Read more
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Signal detection and management information day
This information day will review signal detection and management activities essential to the overall risk management process of a medicinal product. Read more
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Highlights from the European Medicines Agency industry platform meeting held on 21 April 2016 on the operation of the centralised procedure for human medicinal products
The purpose of these platform meetings between regulators and representatives of industry stakeholder organisations is to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. Read more
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Communication of Notified Prices through GAM
With the purpose of facilitating the
process of communication of notified prices, the Management of Accessibility to
Medicinal Product (GAM) application was updated with a new module, available
from 01/09/2016 – GAM – Module 10 – Regimen of Notified Prices.
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EMA - requirements for quality documentation concerning biological investigational medicinal products
The European Medicines Agency published a draft “Guideline on the
requirements for quality documentation concerning biological
investigational medicinal products in clinical trials”.
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USP revised about thirty Ophthalmic Ointment Monographs
On July 29, 2016, the
United States Pharmacopeia (USP) posted a new Revision Bulletin regarding
approximately thirty Ophthalmic Ointment Monographs.The revised monographs
became official on August 1, 2016.
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FDA Asks Manufacturers of Syringe Pumps to Revise Labels, Warnings
Manufacturers of syringe pumps are being asked to update their labels to address flow continuity concerns that the FDA has identified as a serious risk to health.
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Minutes of the PRAC meeting 06-09 June 2016
Pharmacovigilance Risk Assessment Committee (PRAC)
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Implementation of ICH Q3D within the CEP Procedure
The EDQM has implemented the requirements of the ICH
Q3D Guideline on elemental impurities also for the CEP procedure and
has published a new policy document. Read more here about what
has to be considered when applying or renewing a CEP, or for already
existing CEPs with regard to elemental impurities in APIs.
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REACH 2018: Assess your substance to show safe use
Companies registering the same substance must work together to compile
and share information on the uses, hazards and risks of their substance
to demonstrate safe use. If new data involving animal testing needs to
be generated, alternatives must always be considered first. All
information should be reported in a registration dossier and submitted
to ECHA by 31 May 2018.
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Send and receive information on adverse drug reactions (ADRs)
How marketing authorisation holders should inform MHRA of an ADR to a medicine, using the E2B messaging system.
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Signal management
Designated medical events (update). EMA has developed a list of designated medical events containing medical conditions that are inherently serious and often medicine-related. It does not address product specific issues or medical conditions with high prevalence in the general population. The list contains Medical Dictionary for Regulatory Activities (meDRA) terms and serves as a safety net in signal detection. Read more
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Is AQL Testing required within the 100% Visual Inspection?
One of the most frequently asked questions is whether an additional testing based on samples is required after the 100% visual inspections of parenterals. The answer is: basically, "yes". Read more
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Guideline on good pharmacovigilance practices (GVP): Product- or population-specific considerations II: Biological medicinal products with tracked changes
Track-change version
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Data integrity: key to public health protection
The European Medicines Agency (EMA) has released new good manufacturing practice (GMP) guidance to ensure the integrity of data that are generated in the process of testing, manufacturing, packaging, distribution and monitoring of medicines. Regulators rely on these data to evaluate the quality, safety and efficacy of medicines and to monitor their benfit-risk profile throughout their life span. Controlling of data records helps ensure that the data generated are accurate and consistent to support good decision-making by both pharmaceutical manufacturers and regulatory authorities. Read more
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EMA publishes Q&A Document on Production of WFI not obtained by Distillation
The revision of chapter 0169 of the European Pharmacopoeia will introduce in Europe as of April 2017 the possibility to produce WFI using other techniques than distillation. However, many questions are still unanswered like for example how the robustness of the new procedure compared to distillation should be demonstrated. The now published paper has been therefore highly antecipated. Read more
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Human medicines highlights - July 2016
The newsletter is addressed primarily to organisations representing patients, consumers and healthcare professionals. It provides a summary of key information relating to medicines for human use published during the previous month by the European Medicines Agency. Read more
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Send and receive information on adverse drug reactions (ADRs)
How marketing authorisation holders should inform MHRA of an ADR to a medicine, using the E2B messaging system. Read more
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What does Brexit mean for the QP?
The decision of the U.K. to leave the EU has caused a high uncertainty throuhgout industry - and also in the pharmaceutical industry. The European QP Association has received a number of questions on what Brexit actually means for QPs. For that reason the EQPA leadership team has prepared some information. Read more
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PRAC recommendations on signals adopted at the PRAC meeting of 4-8 July 2016
Adopted Read more
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WHO Technical Report - GMP for Biological Products adopted
As a part of their Technical Report Series with guidance documents comprising recommendations for biological products, the The World Health Organization (WHO) now published "Annex 2 - WHO good manufacturing practices for biological products". Read more
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Annual report of the Pharmacovigilance Inspectors Working Group for 2015
This document is the eighth annual report of the Pharmacovigilance Inspectors Working Group (PhV IWG). The PhV IWG has been established by the European Medicines Agency (hereinafter "the Agency") within the scope of Article 57(1)(i) of Regulation (EC) No. 726/2004. Read more
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Revision of application forms “Request for new Certificate of Suitability” and “Request for revision or renewal of Certificate of Suitability”
The application forms for the submission of new CEP applications and for requests for revision/renewal have been slightly revised. Read more
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WHO Draft on Analytical Method Validation
The World Health organization (WHO) recently published a draft document on analytical method Validation for comment. Read more
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Good pharmacovigilance practice (GPvP)
Comply with good pharmacovigilance pratice, complete a compliance report and prepare for an inspection. Read more
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EMA recommends suspension of medicines over flawed studies at Semler Research Centre
The European Medicines Agency (EMA) has recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd., Bangalore, India. The Agency has also recommended that medicines currently being evaluated for aulthorisation and which rely only on bioequivalence studies from this site should not be authorised until bioequivalence is demonstrated using alternative data. Read more
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MHRA GxP Data Integrity Definitions and Guidance for Industry
MHRA has produced draft GxP data integrity guidance for industry and they welcome your comments. Read more
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Elaboration of New USP General Chapter - Analytical Procedure Lifecycle - announced
On June 24, 2016, the USP announced the elaboration of a new general chapter regarding life cycle management of analytical methods. Read more
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Agenda - CHMP agenda of the 18-21 July 2016 meeting
CHMP agenda of the 18-21 July 2016 meeting
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System of Reference Prices – Amendment of new homogeneous groups
The list of Homogeneous Groups and of unit reference process to be in force in the 3rd trimester of 2016 will be updated with the inclusion of 4 new homogeneous groups, for which the reference price was approved (GH1078, GH1079, GH1080 and GH1081) - diclofenac + misoprostol, modified-release tablet, 75 mg + 0,2 mg and omeprazole, gastro-resistant capsule, 10 mg. Read more
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Health claims guidance update – have your say on revised scientific and technical requirements
EFSA has launched a public consultation on its revised scientific and technical guidance for the preparation and presentation of a health claim application. Interested parties have until 12 September 2016 to submit comments on the draft document. Read more
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ICH M4E(R2) Guideline reaches Step 4 of the ICH Process
The revised version of the ICH M4E(R1) Guideline on Enhancing the Format and Structure of Benefit-Risk Information in ICH reached Step 4 of the ICH Process in June 2016 and now enters the implementation period (Step 5). Read more
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Example by Inspectorate for Handling Temperature Excursions
In a recent blog, the MHRA is illustrating its opinion with an example of a short-term temperature excursion during the transport of a product from a third country to the EU. Read more
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ICH E17 Guideline reaches Step 2b of the ICH Process
The ICH E17 Guideline on Multi-Regional Clinical Trials reaches Step 2b of the ICH Process in June 2016 and now enters the consultation period (Step 3). This new ICH Guideline is proposed to provide guidance on general principles on planning/designing Multi-Regional Clinical Trial (MRCT). Read more
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EU Aims For U.S., EU Regulatory Harmonization on Approval, Guidelines and GMP
The European Union wants to expand ongoing trade talks between the U.S. and EU to address regulatory harmonization on drug approval requirements, guidelines and GMP compliance. Read more
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Questions and answers: Article 29(4) referral procedures
This page lists questions that stakeholders, particulary marketing authorisation holders (MAHs)/applicants, may have on Article 29(4) referral procedures. Read more
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WHO publishes Draft of an Umbrella Guideline on Process Validation
At the end of 2015, the WHO adapted its Appendix 7 to the latest technological standards. Appendix 7 provides support with regard to non-sterile process validation. Now, further changes to WHO guidelines are in sight. One of these changes concerns the guideline on process validation which is currently available as a draft and can be commented on until July, 12th 2016. Read more
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PRAC recommendations on signals adopted at the PRAC meeting of 6-9 June 2016
This document provides an overview of the recommendations adopted by the Pharmacovigilance Risk Assessment Committee (PRAC) on the signals discussed during the meeting of 6-9 June 2016 (including the signal European Pharmacovigilance Issues Tracking Tool [EPITT] reference numbers). Read more
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Annex 16: How a QP should handle unexpected Deviations
In a recent blog of MHRA, the inspectorate looks at one aspect of the new Annex 16 - the handling of unexpected deviations. Read more
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Medicines and Healthcare products Regulatory Agency statement on the outcome of the EU referendum
The Agency´s response to the outcome of the EU referendum. Read more
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EMA public workshop on extrapolation of efficacy and safety in medicine development
Update - European Medicines Agency, London, UK, From: 17-May-2016, To: 18-May-2016
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Variations and Revocations of Medicinal Products Prices
Newsletter no. 096/CD/8.1.6 - Regimen of Notified Prices.
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European Union (EU) workshop on ICH Q3D from a quality perspective
Update: European Medicines Agency, London, UK, From: 05-Apr-2016, To: 06-Apr-2016
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Current Issues of GDP Oversight
Since the publication of the EU GDP Guideline in March 2013 various measures for GDP oversight have been taken. While comprehensive measures exist in the area regulated by the EU GDP guidelines, there still are areas where oversight is insufficient or where diverse interpretations raise questions and issues.
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System of Reference Prices – 3rd Trimester of 2016
The list of Homogeneous Groups and the unit reference prices to be force in the 3rd trimester of 2016 was approved by delibaration no. 53/CD/2016, of 9 June 2016, of the Board of Directors, and enters into force on 1 July 2016
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FDA releases new internal policy on ICH Q8, Q9, Q10 Guidelines
On May 18, 2016, the US Food and Drug Administration (FDA) released a new policy document on applying ICH Q8, Q9, and Q10 principles to chemistry, manufacturing, and controls review. Read more
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Revision of the general Chapter on Pharmaceutical Water in the US Pharmacopoeia
The 2nd supplement of USP39 NF34 comprises the revised version of the chapter on pharmaceutical water of the US Pharmacopeia Water for pharmaceutical purposes. Read more
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Periodic safety update reports
This page includes information on periodic safety update reports (PSURs), European Union (EU) reference dates for medicines and the frequency of submission of PSURs. Read more
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Leaflet - eHealth: connecting health systems in Europe
Leaflet - eHealth: connecting health systems in Europe.
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TTIP: The End of FDA Inspections in Europe?
Would the implementation of TTIP bring an end to FDA inspections in the EU? This is discussed in the EU proposal for a respective annex on medicinal products. Read more
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Requirements on submissions (number and format) for Variations and Renewals within MRP and National procedures
Update Read more
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Regulation of advanced therapy medicines
The European Medicines Agency (EMA) published a report from a multi-stakeholder expert meeting held on 27 May 2016 to explore possible ways to foster the development of ATMPs in Europe and expand patients acess to these new treatments. Read more
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedure: document with track changes
Update Read more
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Regulatory information – A new operating model for procedure management to improve support for evaluation procedures
The Agency is introducing a new operating model for the management of evaluation procedures. With the new model procedure managers and procedure assistants will be allocated per product, rather than per procedure, in order to improve the co-ordination of regulatory activities with a product, particularly where multiple regulatory procedures are run in parallel for same product. The strong procedural focus that has already been archieved with the current model will be maintained and strengthened throught the creation of process-focused communities that comprise EMA staff specialising in specific procedures. Read more
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Newsletter no. 082/CD/100.20.200. – 30/05/2016 – Communications Platform – Transparency and Publicity
The Communications Platform - Transparency and Publicity was updated in order to facilitate its use, as well as bearing in mind its inclusion in the NHS Portal. Read more
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Ordinance no. 154/2016 - NATIONAL OFFICIAL JOURNAL NO. 102/2016, Series I of 2016-05-27
Regulates the regimen of prices notified of the medicinal products subject to medical prescription not reimbursed or non-reimbursable, in the terms of Ordinance no. 195-C/2015, of 30 June. Read more
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WHO issues revised Guideline on HVAC Systems
The World Health Organization (WHO) recently issued a guideline for commenting which describes the requirements for HVAC systems for the manufacture of non-sterile forms. As most guidelines on this address on this topic address the requirements for sterile dosage forms, the previous version was gladly accepted by industry. Read more
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EMA post-authorisation procedural advice for users of the centralised procedure
The European Medicines Agency (EMA) recently published an updated Questions and Answers paper on post-authorisation procedural advice for users of the centralised procedure. Read more
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Accessing key EMA information on human medicines
A guide, released last week by the European Medicines Agency (EMA), describes information the Agency publishes on centrally and non-centrally authorised medicines for human use. Read more
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INFARMED SIMPLEX: Licensing of pharmacies and saving in medicinal products will be simpler.
The licensing of pharmacies will be a simplex process, totally performed in an electronic portal associated to the website INFARMED, I.P.. This will be on of the nine ambitious SIMPLEX + measures allocated to the medicinal product regulator, which will benefit more than thousand addressees, between pharmacies, companies and entrepreneurs. The 255 Simplex measures were public announced yesterday. Read more
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Progress in science, medicine and health
The European Medicines Agency´s (EMA) 2015 annual report published today focuses on the Agency´s core tasks which include the evaluation of medicines, support to research and development of new and innovative treatments and the monitoring of the benefits and risks of medicines in real life. Read more
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Press Release – Infarmed reassesses the reimbursement of 115 more expensive medicinal products
INFARMED, I.P. is reassessing the reimbursement of the non-generic (brand) medicinal products that have a price 20% higher than therapeutic alternatives used with the same purpose and also non-generic. This reassessment may imply the non-reimbursement of these medicinal products, unless the laboratories making them available adjust the prices down to this limit. Read more
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CMDh Best Practice Guide on the compilation of the dossier for New Applications submitted in Mutual Recognition and Decentralised Procedures (May 2016)
The objective for this Best Practice Guide (BPG) is to emphasise the importance of taking care in the compilation of the dossier for a Marketing Authorisation Application (MAA), to minimise delays in validation, to avoid invalidation of submissions, to forestall questions from Member States (both RMS and CMS), and to enhance the efficiency of the regulatory process.
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Draft reflection paper on the dissolution specification for generic oral immediate release products
Draft: consultation open Read more
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Can regulators influence the affordability of medicines?
The growing problem of high medicine prices and its impact on the sustainability of health care systems is getting more and more attention in many countries around the globe. Regulators are willing to play their part in solving the problem and in facilitating continued access of patients to safe and effective medicines. In an article published yesterday in the New England Journal of Medicine (NEJM) two representatives of the European Medicines Agency (EMA), i.e. its Executive Director and Senior Medical Officer, as well as Heads of two national agencies discuss possible regulatory interventions. Read more
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NTA update of volume 6A
Volume 6 of the publications "The rules governing medicinal products in the European Union" contains a list of regulatory guidelines related to procedural and regulatory requirements such as renewal procedures, dossier requirements for Type IA/IB variation notifications, summary of product characteristics (SPC), package information and classification for the supply, readability of the label and package leaflet requirements. Read more
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USP publishes draft of a new general chapter <661.3> for plastic components used in manufacturing
In the Pharmacopoeial Forum (PF) 42(3) (May-June 2016) the USP General Chapters - Packaging and Distribution Expert Committee proposes a new chapter to address the qualification of plastic components used in the manufacture of APIs (pharmaceutical and biopharmaceutical) and drug products (DPs). The proposed Title of the new chapter <661.3> is Plastic Components and Systems Used in Pharmaceutical Manufacturing. Read more
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Deliberation no. 797/2016 - NATIONAL OFFICIAL JOURNAL NO. 89/2016, Series II of 2016-05-09
Extinction of the Unit of Information Mangement; creation of the Unit of Management of the Medicinal Product and Medical Devices Account Read more
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Decide if your product is a medicine or a medical device
How the Medicines and Healthcare products Regulatory Agency (MHRA) makes decisions on what is a medicine or medical device (borderline products). Read more
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Excipients labelling
The European Medicines Agency (EMA) published background documents on excipients for inclusion in the label and package leaflet of human medicines. Read more
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EMA publishes finalised Process Validation Guideline for Biotech Products
Approximately two years ago the EMA published a draft guideline on process validation for the manufacture of biotech products. Now the final guideline has been published under the title "Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission." Read more
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Training course on Variations – Filling Variations (23-24/05/2016)
The
increasing growth of the volume and complexity of the regulatory requirements
related to the Filling and Submission of Variations has been a constant in the
life of all the Regulatory Affairs professionals and of many other
professionals. Having
identified this gap in the panorama of services provided in Portugal, Phagecon
will organise, on the days 23 and 24 May in Lisbon, the training “Filling
Variations”. This
training will be given by Andrew Willis, a professional with 30 years of
experience in some of the biggest companies of the world and that gives the
same training in the reputable PTI (Pharmaceutical Training International), Take
advantage of the last seats available of this excellent opportunity. Come enjoy
top training in the entire World.
To do so
just click on the link below and fill the applicable form and send the proof of
payment with identification of the company and trainee to the email – training@phagecon.pt
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Article 58 applications: Regulatory and procedural guidance
Article 58 of Regulation (EC) No 726/2004 allows the Agency´s Committee for Medicinal Products for Human Use (CHMP) to give opinions, in co-operation with the World Health Organization (WHO), on medicinal products for human use that are intended exclusively for markets outside of the European Union (EU). Read more
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Integrating patients’ views in clinical studies of anticancer medicinesThe European Medicines Agency (EMA) has published new guidance on the use of patient-reported outcome (PRO) measures in oncology studies. The new guidance is an appendix to the guideline on the evaluation of anticancer medicinal products in man, which was last revised in July 2013. Read more
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Quality of medicines questions and answers: Part 1
These questions and answers address a number of questions that have been brought to the attention ot the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have developed and are maintained by the QWP. Read more
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Draft concept paper on an addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections (CPMP/EWP/558/95 Rev. 2) to address paediatric-specific clinical data requirements
Draft: consultation open Read more
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GMP/GDP: When will I be inspected by the Authoritie
Various competent authorities are performing inspections. But who is subject to such an inspection? Read more
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Good laboratory practice (GLP) for safety tests on chemicalsAs a test facility, comply with regulatory requirements for carrying out product safety tests for human health, animal health or the environment. Read more
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Briefing note to marketing authorisation holders/applicants on the European Medicines Agency Patient Registry Initiative
Through the Patient Registry Initiative launched in September 2015, the EMA aims to facilitate
interactions between registry co-ordinators and potential users of registry data both at an early stage
of the development, during the marketing authorisation evaluation procedure and post-authorisation.
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Update of the list of medicinal products subject to previous notification of exportation or distribution to other member-states
Deliberation no. 661/2016, of 26 March, updates the list of
medicinal products whose consumptions, exportation of distribution to other
Member-States of the European Union depend on the notification to Infarmed.
This list enters into force on the 5th day after being published, i.e., on 20th
April.
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Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container
Draft: consultation open
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Deliberation no. 662/2016 - National Official Journal no. 72/2016, Series II of 2016-04-13Regulation of functioning of the Evaluation Committee of the Health Technologies - CATS Read more
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Methodological guidelines and recommendations for efficient and rational governance of patient registries
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Implementation of the ISO IDMP standardsThe European Medicines Agency (EMA) is in the process of implementing the standards developed by the International Organization for StandardizationExternal link icon (ISO) for the identification of medicinal products (IDMP). These are a set of common global standards for data elements, formats and terminologies for the unique identification of and the exchange of information on medicines. Following a phased implementation process, pharmaceutical companies will be required to submit data on medicines to EMA in accordance with these formats and terminologies. Read more
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List of European Union reference dates and frequency of submission of periodic safety update reports
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The new Annex 16 is coming into ForceThe new Annex 16 "Certification by a Qualified Person and Batch Release" will become effective as of 15 April 2016. The contents will reflect the coming state of expectations regarding the batch release. Read more
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Orphan designationThis section provides guidance and procedural information on applying for orphan designation for medicines for rare diseases in the European Union (EU). It also includes information on what happens after a designation has been granted, including the incentives available for sponsors developing orphan medicines. Read more
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Fees payable to the European Medicines AgencyThe European Medicines Agency charges fees for the services it provides. The rules relating to the Agency's fees are governed by the fee Regulation (Council Regulation (EC) No 297/95) and its implementing rules, as well as the pharmacovigilance fee Regulation (Regulation (EU) No 658/2014). Read more
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Parallel scientific advice from regulators and health-technology-assessment bodiesThe European Medicines Agency (EMA) offers scientific advice and protocol assistance in parallel with health-technology-assessment (HTA) bodies. This procedure aims to allow medicine developers to gain feedback from regulators and HTA bodies at the same time, at any point in the developmental lifecycle of medicines. This helps them to establish the evidence that both parties will need to determine a medicine's benefit-risk balance and value as efficiently as possible. Read more
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QP Education and Qualification - What is needed?We are frequently asked about the educational requirements in order to become a Qualified Person in Europe. Comprehensive educational modules are offered, especially in the UK. These training courses contain different topics like pharmaceutical law, Microbiology, Quality Management etc and require the trainee to take part in multiple courses over an extended period. But is this needed to become a QP in Europe? Read more
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TRAINING COURSE ON GENERICS MASTERING REGULATORY AND DEVELOPMENT STRATEGIES FOR GENERICS (18-19/04/2016)The growing increase of the volume and complexity of the regulatory requirements regarding Generic Medicinal Products has been a constant in the life of all the Regulatory Affairs professionals. Having identified this gap in the panorama of services provided in Portugal, Phagecon will organise, on the days 18 and 19 April in Lisbon, the training Training course on Generics Mastering Regulatory and Development Strategies for Generics. This training will be given by Andrew Willis, a professional with 30 years of experience in some of the biggest companies of the world and that gives the same training in the reputable PTI (Pharmaceutical Training International). Take advantage of the last seats available in this excellent opportunity. Come enjoy top training in the entire World. To do so just click on the link (http://www.phagecon.pt/files/Training_Course_on_Generics.pdf) and fill the applicable form and send the proof of payment with identification of the company and trainee to the email training@phagecon.pt Read more
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Reflection paper on assessment of cardiovascular safety profile of medicinal productsAdopted Read more
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EMA publishes GVP Module V (Revision 2) for public commentModule V of the Guideline on Good Pharmacovigilance Practice (GVP) has been revised by the European Medicines Agency (EMA). Deadline for Comments is May 31, 2016. Module V covers the topic "Risk Management". Read more
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Ordinance no. 48/2016 National Official Journal no. 57/2016, Series I of 2016-03-22Determines that the medicinal products meant for the treatment of patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, polyarticular juvenile idiopathic arthritis and plaque psoriasis benefit from an exceptional reimbursement regimen. Read more
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 14-17 March 2016In March, the Pharmacovigilance Risk Assessment Committee (PRAC) concluded one safety review. It also discussed three new safety reviews. For one of these, regarding the cancer medicine Zydelig, the PRAC proposed provisional measures, as a precaution, to protect patients while the medicine is being reviewed. Read more
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Post-orphan medicinal product designation procedures: guidance for sponsorsThe opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA). Read more
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European Medicines Agency/International Federation for Animal Health Europe info day 2016European Medicines Agency, London, UK, From: 17-Mar-2016, To: 18-Mar-2016. The info day covers the latest developments in the scientific review, regulation and marketing authorisation procedure. It is an opportunity for professionals to get first-hand information on current developments in the veterinary regulatory scene. Registration open. Read more
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Already 13 EMA GMP Non-compliance Reports in 2016 publishedEudraGMDP is the central database for GMP and GDP compliance. Inspections which have been performed by any of the EU member state inspectorates are published in the database. Read more
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Update of the Platform of Management of Accessibility of the Medicinal ProductThe ruptures of existences, even though merely transient, of manufacturing or supply of a medicinal product, as well as any disturbance to the normal supply of the market, are a concern of this Authority, being part of its mission to ensure the access of the healthcare professionals and of the citizens to quality, effective and safe medicinal products. Read more
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FDA Guideline on Dissolution TestingThe FDA has presented the draft of a revised guideline on dissolution testing for immediate release. Under certain conditions, the tests can now be standardised. Read more
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PRIME: priority medicinesPRIME is a scheme launched by the European Medicines Agency (EMA) to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. Read more
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Runoff deadlines elapsing from the application of the Annual Prices RevisionAs disclosed in Newsletter no. 193/CD/8.1.6., of 25/11/2015, the runoff deadline, in the pharmacies, of the packages with the maximum prices previous to those resulting from the annual prices revision of non-generic medicinal products is as follows: 60 working days, counting from 01-01-2016 (up to 28-03-2016). Read more
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Guidance for the publication of clinical dataThe European Medicines Agency (EMA) has published detailed guidance for pharmaceutical companies on the requirements to comply with its policy on the publication of clinical data. Read more
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ICH guideline S1 - Regulatory notice on changes to core guideline on rodent carcinogenicity testing of pharmaceuticalsAdopted Read more
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Ordinance no. 3206/2016 - National Official Journal no. 43/2016, Series II of 2016-03-02Establishes dispositions about the reference process of people with reactive tests or infected by the viruses of hepatitis B and C, or with other sexually transmitted infections, coming from services and establishments of the National Health Service (NHS) or from entities that have celebrated agreements with the NHS for the providing of health. Read more
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Ordinance no. 35/2016 - National Official Journal no. 42/2016, Series I of 2016-03-01Establishes the State reimbursement regimen in the maximum price of the reagents (test strips) for determination of blood glucose, ketonemia and ketonuria and of the needles, syringes, lancets and other medicinal devices for the purpose of self-monitoring of people with diabetes, to beneficiaries of the National Health Services and revokes Ordinance no. 222/2014, of 4 November. Read more
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Government and operators of the medicinal product circuit sign CommitmentThe Ministry of Health and the associations representative of the pharmaceutical industry and medical devices, the wholesale distributors and the pharmacies signed a Commitment for the Sustainability and the Development of the National Health Service (NHS) based on four strategical principles: access, innovation and sustainability; rational use of the medicinal product and health products; market supervision; and investigation, development and competitiveness. The agreement negotiated along the last months was signed on 26th February, in a ceremony that had the presence of the President of the Bar of the Portuguese Pharmacists Association. Read more
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Order No. 2935-B/2016 - National Official Journal No. 39/2016, 1st Supplement, Series II of 25-02-2016Establishes provisions in order to enhance the generalisation of the dematerialised electronic prescription (Paperless Prescription), in the National Health Service, creating specific targets for its realization Read more
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Recall of medicinal products manufactured by Farma Mediterrània, S.L.After the inspection performed by the Spanish Agency to the manufacturer Farma Mediterrània, S.L. (Spain), critical and major non-conformities to the Good Manufacturing Practices have been detected. Read more
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ICH publishes Training Modules on "ICH Q3D - Elemental Impurities"The ICH has recently published 7 training modules on the ICH Q3D Guideline "Elemental Impurities". Read more
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Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human useCertain aspects of the implementation of the Falsified Medicines Directive (Directive 2011/62/EU) and the new delegated act on the safety features (Commission Delegated Regulation (EU) 2016/161 - "the Delegated Regulation") may impact on the product information and the marketing authorisation dossier; in particular the placing of safety features, a unique identifier (UI) carried by a 2-D barcode and an anti-tampering device (ATD), on the packaging of prescription medicines and certain nonprescription medicines for the purposes of authentication and identification. Read more
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Sistema de Preços de Referência - Aditamento de novos grupos homogéneosA lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 1.º trimestre de 2016 será atualizada com a inclusão de 2 novos grupos homogéneos, para os quais foi aprovado o respetivo preço de referência (GH1070 e GH1071) da substância ativa Rasagilina de 1 mg. Read more
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Requirements on submissions (number and format) for New MA Applications and Variations and Renewals within MRP, DCP or National procedures
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Progress report of the UK reclassification platformPublication of the first years work of the UK stakeholders' reclassification platform. Read more
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Project Via Verde do Medicamento (Fast Access to the Medicinal Product)INFARMED, I.P. celebrated on 17th July 2015, a collaboration protocol with the professional associations of the sector of the medicinal product (APIFARMA, ANF, GROQUIFAR and AFP), with the name Project Via Verde do Medicamento (Fast Access to the Medicinal Product), which has been taking place in pilot stage in the district of Coimbra. Due to the results obtained in the pilot stage, the Project Via Verde do Medicamento (Fast Access to the Medicinal Product) will spread to all the mainland, from 15th February 2016. Read more
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Standard operating procedure for eligibility to the centralised procedure for medicinal products for human use
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Falsified medicinesFalsified medicines are fake medicines that pass themselves off as real, authorised medicines. The European Union (EU) has a strong legal framework for the licensing, manufacturing and distribution of medicines, centred around the Directive on falsified medicines for human use, so that only licensed pharmacies and approved retailers are allowed to offer medicines for sale, including legitimate sale via the internet. The European Medicines Agency is working closely with its partners on the implementation of these laws. Read more
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List of Union reference dates and frequency of submission of periodic safety update reports (PSURs)
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The GMP year 2015 - what was new in the EU?The previous year 2015 was another eventful year. Again there were new developments in the GMP environment as well as announcements of changes that preoccupied the pharmaceutical industry. Read more
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The World Health Organisation declares the Zika virus outbreak a Public Health Emergency of International Concern
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Dossier requirements for submission of marketing authorisation and maximum-residue-limit applications to the European Medcines Agency and to members o
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DESPACHO N.º 1571-B/2016 - DIÁRIO DA REPÚBLICA N.º 21/2016, 1º SUPLEMENTO, SÉRIE II DE 2016-02-01Determina que é obrigatória a centralização da aquisição de bens e serviços específicos da área da saúde, para todos os serviços e instituições do Serviço Nacional de Saúde (SNS) e órgãos e serviços do Ministério da Saúde, sendo esta assegurada pela SPMS - Serviços Partilhados do Ministério da Saúde, E. P. E. Read more
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Qualification of novel methodologies for medicine developmentThe European Medicines Agency offers scientific advice to support the qualification of innovative development methods for a specific intended use in the context of research and development into pharmaceuticals. Read more
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DGAV presta esclarecimentos sobre o suplemento alimentar 'CALCITRIN MD'Na sequência das notícias vindas a público sobre o suplemento alimentar 'Calcitrin MD', a Direção Geral de Alimentação e Veterinária (DGAV), enquanto Autoridade Competente em matéria de suplementos alimentares, esclarece o enquadramento legal do CALCITRIN e dos suplementos alimentares no geral. Read more
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Increasing access to reports on adverse reactions to medicinesThe European Medicines Agency (EMA) will give increased access to reports on suspected adverse reactions to medicines authorised in the European Union (EU), while guaranteeing that personal data will be fully protected. This is the outcome of a revision of EudraVigilance Access policy, which was adopted by EMAs Management Board at its December 2015 meeting. The adoption followed a broad public consultation generating close to 400 comments which have been taken into account in the final policy. Read more
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Canadian Food Inspection Agency and EFSA enhance cooperation in risk assessmentEFSA and the Canadian Food Inspection Agency (CFIA) have agreed to enhance their scientific cooperation and dialogue related to risk assessment. Martine Dubuc, Vice-President of Science and Chief Food Safety Officer of CFIA, and Bernhard Url, Executive Director of EFSA, signed a Memorandum of Cooperation on 14 December 2015 for an initial period of five years. Read more
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European Medicines Agency public workshop on extrapolation of efficacy and safety in medicine developmentEuropean Medicines Agency, London, UK, From: 17-May-2016, To: 18-May-2016. The European Medicines Agency (EMA) published in 2013 the concept paper on extrapolation of efficacy and safety in medicine development. Its aim is to discuss the need and possibility to develop a framework for extrapolation approaches that are considered scientifically valid and reliable to support medicine authorisation. The framework shall set out a structured approach to be followed for each extrapolation exercise to improve interactions with stakeholders and to standardise decision making across committees. Further to the extrapolation expert meeting that took place in September 2015, EMA will publish a reflection paper on extrapolation across age groups that will include considerations specific to global product development and licensing of paediatric medicines. EMA will host an open workshop on 17-18 May 2016, with a view to present the reflection paper and seek feedback from developers. Read more
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Applications for new human medicines under evaluation by the CHMP: December 2015This document lists information on applications for centralised marketing authorisation for human medicines that the European Medicines Agency has received for evaluation. It includes the international non-proprietary names (INN) and therapeutic areas for all new innovative medicines under evaluation by the Committee for Medicinal Products for Human Use (CHMP). For generic and biosimilar medicines, it includes the INN (active moiety only, with no information on salt, ester or derivative) and therapeutic area. Read more
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EMA ready to address challenges aheadSupport to innovative medicines, transparency and patient involvement will be among the priorities of new EMA Executive Director Guido Rasi Read more
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PREFOR - Portal de Registo de Fornecedores do INFARMED, I.P.O Portal PREFOR conduzirá à constituição de um repositório de informação dos fornecedores do INFARMED, I.P. permitindo agilizar os procedimentos de aquisição por ajuste direto, essencialmente no que respeita à fase de seleção dos fornecedores. Read more
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PORTARIA N.º 417/2015 - DIÁRIO DA REPÚBLICA N.º 238/2015, SÉRIE I DE 2015-12-04Primeira alteração à Portaria n.º 223/2015, de 27 de julho, que regula o procedimento de pagamento da comparticipação do Estado no preço de venda ao público (PVP) dos medicamentos dispensados a beneficiários do Serviço Nacional de Saúde (SNS) e à Portaria n.º 224/2015, de 27 de julho, que estabelece o regime jurídico a que obedecem as regras de prescrição e dispensa de medicamentos e produtos de saúde e define as obrigações de informação a prestar aos utentes Read more
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The QP Declaration: some Questions remain openMore than one year after the final guidance on the QP Declaration was published, some questions remain open or are frequently asked by the stakeholders. The most important ones have been summarised in a CMDh document. Read more
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Good-clinical-practice complianceGood clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected and that clinical-trial data are credible. Read more
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Good practice guide on risk minimisation and prevention of medication errorsThe European Medicines Agency (EMA) in collaboration with the EU regulatory network was mandated to develop regulatory guidance for medication errors, taking into account the recommendations of a stakeholder workshop held in London in 2013. Read more
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FAQ: foods for special medical purposesEFSA has published scientific and technical guidance that will help the European Commission to apply new rules on foods for special medical purposes (FSMPs). But what are these products and how will the new rules work? Our nutrition specialists answer the key questions. Read more
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Revisão anual de preços dos medicamentos não genéricosMercado Ambulatório e Hospitalar - 2016 Read more
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Post-orphan medicinal product designation procedures: guidance for sponsorsThe opinions on orphan designation are adopted by the Committee for Orphan Medicinal Products (COMP) at their monthly meetings at the European Medicines Agency (EMA). Read more
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Medicinal products for human use: monthly figures - October 2015This document provides current information related to the volume and evaluation of marketing authorisation and post-authorisation applications for medicinal products for human use received by the European Medicines Agency. Read more
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PORTARIA N.º 406/2015 - DIÁRIO DA REPÚBLICA N.º 229/2015, SÉRIE I DE 2015-11-23Primeira alteração à Portaria n.º 55/2013, de 7 de fevereiro, que define as categorias de bens e serviços específicos da área da saúde cujos contratos públicos de aprovisionamento (CPA) e procedimentos de aquisição são celebrados e conduzidos pelos SPMS - Serviços Partilhados do Ministério da Saúde, E. P. E. Read more
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Plataforma MEDVETA partir de hoje, encontra-se disponível no portal da DGAV a informação relativa aos medicamentos veterinários (MV) autorizados, inseridos numa plataforma - MEDVET - a qual pretende ser uma ferramenta de trabalho para todos os envolvidos no domínio do medicamento veterinário, facilitando o acesso e consulta da informação relevante para uma utilização correta e racional dos medicamentos veterinários. Read more
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Public consultation on a new notice on orphan medicinal products launched on 17/11/2015The European Commission is proposing to review the 2003 Communication on orphan medicinal products to streamline the regulatory framework and to adapt the Communication to technical progress. The 2003 Communication will be replaced by a notice. Read more
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New strategy to fight antimicrobial resistanceThe European Medicines Agency has released for public consultation a new strategy on antimicrobials for 2016-2020 adopted by its Committee for Veterinary Medicinal Products (CVMP). The strategy, recognising that antimicrobial resistance is a global problem affecting both animal and human health, sets clear objectives based on a 'One Health' approach to help combat the threat of resistance which may arise from the use of antimicrobials in animals. Read more
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AVISO Manutenção no sistema informático da Phagecon
A Phagecon informa todos os seus clientes que a partir das 14h (horas locais) do dia 01/10/2015 até ao final do dia 05/10/2015 irá proceder a operações de manutenção no seu sistema informático pelo que os seus colaboradores terão acesso condicionado aos seus emails, telefones, bem como a todos os recursos internos informáticos da empresa.
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Medicinal products for human use: monthly figures - August 2015This document provides current information related to the volume and evaluation of marketing authorisation and post-authorisation applications for medicinal products for human use received by the European Medicines Agency. Read more
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Training Course: CTD Module 3: Chemistry, Manufacturing and Controls
A Phagecon Serviços e Consultoria Farmacêutica, Lda vem, por este meio, apresentar uma nova solução no âmbito de formação altamente especializada, que garante um completo entendimento dos requisitos regulamentares europeus, no âmbito do Módulo 3 (CTD) de Medicamentos de Uso Humano.
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Improving health interventions with the support of the EU Health and DPIP Programme (Addiction 2015 conference, 2325 September 2015 -Lisbon, Portugal
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Draft concept paper on requirements for the production and control of allergen products for use in animalsDraft: consultation open Read more
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European Medicines Agency procedural advice for users of the centralised procedure for generic / hybrid applicationsThis document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the EMA position on issues, which are typically addressed during the course of Pre-Submission Meetings. Read more
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Frequently asked questions about parallel distributionThis page lists questions about parallel distribution. The information is available as questions and answers, which the European Medicines Agency (EMA) revises as necessary. Read more
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CEN adopts at European level new revised editions of international standards for management systemsCEN has adopted at European level new revised editions of three of the most successful and widely-used international standards. These standards, which are also recognized as European Standards, may be used by businesses and other organizations wishing to implement Quality Management Systems (EN ISO 9000 and EN ISO 9001) and Environmental Management Systems (EN ISO 14001). Applying these standards can deliver benefits in relation to performance, productivity, efficiency and savings (in terms of costs, energy and waste), leading to higher levels of satisfaction among customers and service-users, employees and other stakeholders. Read more
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Guideline on the evaluation of medicinal products for the treatment of chronic constipation and for bowel cleansingAdopted Read more
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List of Union reference dates and frequency of submission of periodic safety update reports (PSURs)
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Orientações para a utilização prudente de agentes antimicrobianos na medicina veterinária
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eXtended EudraVigilance medicinal product dictionary data-entry tool user manual
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EU: New GMP Implementing Act publishedThe EU Commission has published a new public consultation on an Implementing Act on GMP principles and guidelines for medicinal products for human use. Read more
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Joint European Medicines Agency/Drug Information Association information day on International Organization for StandardizationEuropean Medicines Agency, London, UK, From: 23-Jun-2015, To: 23-Jun-2015. This information day is primarily aimed at providing stakeholders with information to help prepare for the business change to come and at sharing the vision of common European Union (EU) strategy for the International Organization for Standardization (ISO) identification of medicinal products (IDMP) standards implementation in response to a worldwide demand for internationally harmonised specifications for medicinal products. Topics to be addressed relate to background of the IDMP standards and legislation, structure of the IDMP standards, international stakeholders perspective and identification of future direction. This forum is providing opportunity to understand requirements, identify key challenges and to exchange views between regulators, industry, system developers and other stakeholders. Places limited. Read more
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How to apply for orphan designationThis page provides information for sponsors on how to apply to the European Medicines Agency for orphan designation for a medicine. Read more
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Task force for the implementation of International Standards on Identification of medicinal products in the EU (i.e. EU ISO IDMP task force)The Task Force for the implementation of International Standards on Identification of Medicinal Products for human use in the EU (i.e. EU ISO IDMP Task Force) is an expert working group/advisory group co-chaired by an EMA representative, National Competent Authority (NCA) representative and European Pharmaceutical Industry representative. The group comprises of participants from the European Medicines Agency (EMA), Member States, experts nominated by European Pharmaceutical Industry Associations, Software Vendors and interested parties with full understanding of the terminology, the ISO IDMP standards, the European data policies, regulatory procedures and requirements including the data submission practices and the technological constraints of the existing IT infrastructure and applications. Read more
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Requirements on Submissions for Periodic safety update reports (PSUR) to National Competent Authorities (NCAs) for products authorised via National Pr
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EMAs medical literature monitoring enters into full operationThe European Medicines Agency (EMA) starts its full medical literature monitoring service on 1 September 2015. Read more
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FDA Submits Biological Products Naming Rule to OMBThe FDA wouldnt comment on whether the proposal is the expected guidance on naming biosimilars. Read more
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Pharmacovigilance legislationThe new pharmacovigilance legislation, which came into effect in July 2012, was the biggest change to the regulation of human medicines in the European Union (EU) since 1995. It had significant implications for applicants and holders of EU marketing authorisations, as well as for patients, healthcare professionals and regulators. Read more
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Resumo das decisões da União Europeia relativas às autorizações de introdução no mercado dos medicamentos de 1 de julho de 2015 a 31 de julho de 2015
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Summaries of scientific recommendations on classification of advanced-therapy medicinal productsThis page lists the outcome of the assessment of the classification of advanced-therapy medicinal products by the Committee for Advanced Therapies. Read more
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Updated guidance on good clinical practice released for consultationThe European Medicines Agency (EMA) has released an addendum to the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) E6 (R2) guideline on good clinical practice (GCP) for a six-month public consultation. Read more
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Sistema de Preços de Referência - Aditamento de novos grupos homogéneosA lista dos Grupos Homogéneos e dos preços de referência unitários a vigorar no 3.º trimestre de 2015 será atualizada com a inclusão de 11 novos grupos homogéneos, para os quais foi aprovado o respetivo preço de referência (GH1049, GH1050, GH1051, GH1052, GH1053, GH1054, GH1055, GH1056, GH1057, GH1058 e GH1059). Read more
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Needs for paediatric medicinesThe European Medicines Agency is developing an inventory of the needs for paediatric medicines, to help medicinal-product developers identify opportunities. Read more
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Submissão de Pedidos de Avaliação Prévia - Formulário para definição de preços máximos de aquisição de medicamentos de uso hospitalar
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BUV - biocidas de uso veterinário autorizados contendo iodo como substância ativaO Regulamento de Execução (UE) n.º 94/2014, da Comissão de 31 jan. 2014 aprova a utilização da substância ativa iodo, incluindo a polivinilpirrolidona-iodo, em produtos biocidas dos tipos 1, 3, 4 e 22 e fixa o dia 01 de setembro de 2015 como data de aprovação do Iodo e Polivinilpirrolidona-iodo na lista da União de substâncias ativas aprovadas. Read more
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PMF dossier requirements: question and answers on blood establishments inspection status in the plasma master fileThis Question and Answer (Q&A) describes the approach applied in evaluation of the compliance status of blood establishments (BE) registered in Plasma Master File (PMF) applications. It supplements the guidance provided in the PMF Scientific requirements Guideline EMEA/CHMP/BWP/3794/03 (current version). Together with the Q&A, a flow chart is also provided. Read more
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Annual report of the Pharmacovigilance Inspectors Working Group for 2014This document is the seventh annual report of the Pharmacovigilance Inspectors Working Group. Read more
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Outcomes of periodic safety update report single assessmentsThe European Medicines Agency (EMA) publishes the outcomes of single assessments of periodic safety update reports (PSURs) for active substances or combinations of active substances contained in medicines authorised in the European Union (EU). Read more
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Guidelines on good pharmacovigilance practices (GVP)Introductory cover note, last updated with revision 1 of module IV on audits and launch of public consultation of module VIII and its addendum I on post-authorisation safety studies. Read more
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Recommendations on minor-use-minor-species and limited-market classificationsThis page list recommedations on minor-use-minor-species (MUMS) and limited-market classification from the Committee for Medicinal Products for Veterinary Use (CVMP). Read more
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Outcomes of periodic safety update report single assessmentsThe European Medicines Agency (EMA) publishes the outcomes of single assessments of periodic safety update reports (PSURs) for active substances or combinations of active substances contained in medicines authorised in the European Union (EU). Read more
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Reporting requirements for marketing-authorisation holdersMAHs are required to submit information on new marketing authorisations within 15 calendar days from the date of notification of the granting of the marketing authorisation by the National Competent Authority (NCA). Read more
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ICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients questions and answersICH guideline Q7 on good manufacturing practice for active pharmaceutical ingredients questions and answers - Step 5 Read more
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Submissão de traduções (processos de Autorização de Introdução no Mercado, Renovação e Alteração)
Com o objetivo de simplificar o processo de avaliação das traduções dos resumos das características do medicamento (RCM), dos folhetos informativos (FI) e das rotulagens, no âmbito dos pedidos de autorização de introdução no mercado (AIM), alteração aos termos de AIM e renovação pelos procedimentos de reconhecimento mútuo e descentralizado, o Infarmed adotou as seguintes medidas:
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Public-friendly information on herbal medicines now availableSummaries to help people make informed choices when taking herbal medicines From now on the European Medicines Agency (EMA) will systematically publish summaries of the recommendations of its Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of a herbal substance in easy to understand, public-friendly language. Read more
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Recommended submission dates for centralised (initial and extension applications) and maximum-residue-limit procedures 1st phase(120-day assessment)
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Regulatory information Rules on fees are revisedThe European Medicines Agency (EMA) has revised the implementing rules on fees payable to the Agency. The revised implementing rules, which come into effect on 1 August 2015, were adopted by EMA Management Board on 14 July 2015. Read more
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European Medicines Agency pre-authorisation procedural advice for users of the centralised procedureThis integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the pre-submission guidance for access to the hyperlinked information. Read more
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European Medicines Agency regulatory tools for early access to medicinesConditional marketing authorisation and accelerated assessment draft revised guidelines Description of tools and overview of changes Read more
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Quick Response (QR) codes in the labelling and package leaflet of centrally authorised medicinal productsWith the availability of new communication technologies it has become apparent that patients/users of medicinal products may benefit from information provided through electronic formats. In this context, there has been an increased demand by applicants to the centralised procedure to include QR codes in the labelling and/or package leaflet (PL) of medicinal products as an additional way of providing information to patients and health care professionals. Read more
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EMA/PDCO Summary Report on the review of the list of granted Class WaiversThe review and update of waivers (of medicine development for children) is a task of the Paediatric Committee (PDCO) at the European Medicines Agency, as per Article 14 of Regulation (EC) No 1901/2006 (the Paediatric Regulation). The primary aim of this Regulation is to facilitate the development and accessibility of medicinal products for the paediatric population, by offering support for paediatric medicine development, including where this development has not been considered by the pharmaceutical sector. Read more
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Concept paper on the need for a single note for guidance on the chemistry of active substancesDraft: consultation open Read more
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Calculating 'chargeable units' for pharmacovigilance fees as specified in Regulation (EU) No 658/2014The purpose of this document is to describe the method used by the European Medicines Agency, hereafter referred to as the Agency, to determine the number of chargeable units applicable to each marketing authorisation holder for the purpose of levying pharmacovigilance fees. The pharmacovigilance fees referred to in this document relate to the fees laid down in Regulation (EU) No 658/2014 which enables the Agency to collect fees for the conduct of pharmacovigilance activities as assigned to it by the 2010 Pharmacovigilance Legislation that became applicable in July 2012. Read more
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Regulamento (UE) 2015/1190 da Comissão, de 20 de julho de 2015Regulamento (UE) 2015/1190 da Comissão, de 20 de julho de 2015, que altera o anexo III do Regulamento (CE) n.o 1223/2009 do Parlamento Europeu e do Conselho relativo aos produtos cosméticos Read more
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Concept paper on the need for revision of the note of guidance on manufacture of the finished dosage formDraft: consultation open Read more
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Reflection paper on the use of cocrystals of active substances in medicinal productsAdopted Read more
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Public register of parallel distribution now availableThe European Medicines Agency (EMA) is launching a public register of parallel distribution notices, providing a more transparent and user-friendly access to information on centrally authorised medicines put on the market by means of parallel trade in the European Union (EU). Read more
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An Addendum to ICH M7 provides practical Examples to calculate compound-specific Acceptable IntakesThe ICH M7 Guideline has reached Step 4 of the ICH process in June last year. It outlines recommendations for the assessment and control of mutagenic impurities that are present or expected to be present in drug substances or drug products, taking into consideration the intended conditions of human use. Read more
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European Medicines Agency pre-authorisation procedural advice for users of the centralised procedureThis guidance document addresses a number of questions which users of the centralised procedure may have. It provides an overview of the European Medicines Agencys position on issues, which are typically addressed during the course of pre-submission meetings. Read more
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Training Course: Pharmaceutical Semi-Solid Dosage Form: Development, Manufacture & Scale-Up
A Phagecon vem por este meio apresentar uma nova solução no âmbito da Formação altamente especializada para profissionais de Desenvolvimento e Produção. O curso é destinado a pessoas que trabalham no desenvolvimento de formulações semissólidas, seleção de matérias-primas, sistemas de libertação controlada, scale-up e processo de fabrico, validação e testes de qualidade.
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Decisão de Execução (UE) 2015/1131 da Comissão, de 10 de julho de 2015Decisão de Execução (UE) 2015/1131 da Comissão, de 10 de julho de 2015, que altera a Decisão de Execução 2013/505/UE que autoriza a medida provisória tomada pela República Francesa, em conformidade com o artigo 129.o do Regulamento (CE) n.o 1907/2006 do Parlamento Europeu e do Conselho relativo ao registo, avaliação, autorização e restrição dos produtos químicos (REACH), no sentido de limitar a utilização de sais de amónio em materiais de isolamento em pasta (ouate) de celulose [notificada com o número C(2015) 4470] Read more
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Draft guideline on manufacture of the finished dosage formDraft: consultation open Read more
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Day 80 assessment report non-clinical and clinical guidance - generics rev05.15
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Implementação de pagamento por cartão de crédito - Plataformas SMUH-AIM e SMUH-ALTER
As plataformas online Sistema de Gestão de Medicamentos de Uso Humano (SMUH-AIM e SMUH-ALTER) integram o pagamento das taxas aplicáveis através da geração de referências multibanco. No entanto, esta forma de pagamento não está disponível para pagamentos oriundos do estrangeiro, os quais são atualmente efetuados por transferência bancária.
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Implementação de pagamento por cartão de crédito - Plataformas SMUH-AIM e SMUH-ALTER
A Phagecon - Serviços e Consultoria Farmacêutica, Lda., gostaria de informar os seus clientes que o INFARMED I.P. Autoridade Nacional do Medicamento e Produtos de Saúde, publicou, a 07 de julho de 2015, a Circular Informativa N.º 124/CD/100.20.200 (que pode consultar aqui), dirigida a todos os Titulares de AIM e requerentes, relativa ao modo de pagamento de taxas resultantes de submissões nas Plataformas SMUH-AIM (pré-submissão eletrónica de pedidos de autorização de introdução no mercado (AIM)) e SMUH-ALTER (submissão eletrónica de pedidos de alteração aos termos da AIM).
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Q&As for Variations and Pharmacovigilance legislationThis Question and answers section gives advice on regulatory issues in connection with the Mutual Recognition and Decentralised Procedures. Reference is made, where additional information is available from CMDh guidance documents. Read more
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News bulletin for pharmacovigilance programme update - Issue 4This 4th update document captures the important progress made in the development of the pharmacovigilance information systems and services and describes how the Agency is preparing for the successful delivery of these changes, focusing on the most critical questions: what needs to be done by whom and by when. Read more
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Procedural timetablesThis page lists the timetables for the submission, start and finish dates of procedures, as well as other interim dates and milestones that occur during the various procedures. Read more
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Regulatory information Mandatory use of common repository for human centralised procedures as of yesterdayAs of yesterday, 1 July 2015, companies should no longer send their centralised procedure applications for human medicines to individual Member States on CDs/DVDs or via the Common European Submission Platform (CESP). Read more
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Validation checklist for initial marketing authorisation applications pharmaceuticalsThis validation checklist is used by the Agency to validate initial marketing authorisation applications for pharmaceuticals and applicants should use it as a means to review in advance of their submission that standard requirements are fulfilled. Read more
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Dossier requirements for centrally authorised productsSubmission of applications to the European Medicines Agency, Members of the Committee for Medicinal Products for Human use (CHMP), Committee for Advanced Therapies (CAT)* and Pharmacovigilance Risk Assessment Committee (PRAC) Read more
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Annual report of the Good Manufacturing and Distribution Practice Inspectors Working Group 2014This document is the first annual report of the GMP/GDP Inspectors Working Group (GMDP IWG). This group was established at EMA in 1996. Read more
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ICH Q7 Q&A on GMP for APIICH has published the ICH Q7 Questions & Answers on Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. PIC/S contributed to this Q&A document which provides interpretation to GMP for APIs since the implementation of the ICH Q7 Guideline. The ICH Q7 Guideline is originally based on a PIC/S draft guideline on API and was adopted by PIC/S in 2001, then integrated as part II of the PIC/S GMP Guide in 2007. Read more
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'Excipients in the label and package leaflet of medicinal products for human use'Draft: consultation open Read more
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Pharmacovigilance: Information systems and servicesSupporting business activities of the revised pharmacovigilance legislation through better information systems Read more
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DECRETO-LEI N.º 118/2015 - DIÁRIO DA REPÚBLICA N.º 120/2015, SÉRIE I DE 2015-06-23Procede à segunda alteração ao Decreto-Lei n.º 136/2003, de 28 de junho, que transpôs a Diretiva n.º 2002/46/CE, do Parlamento Europeu e do Conselho, de 10 de junho de 2002, relativa à aproximação das legislações dos Estados-Membros respeitantes aos suplementos alimentares Read more
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DELIBERAÇÃO N.º 1157/2015 - DIÁRIO DA REPÚBLICA N.º 119/2015, SÉRIE II DE 2015-06-22Alteração do regulamento que define a lista de medicamentos cuja exportação ou distribuição para outros Estados membros da União Europeia e respetivas quantidades dependem de prévia notificação pelos distribuidores por grosso ao INFARMED, I. P. Read more
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PORTARIA N.º 181/2015 - DIÁRIO DA REPÚBLICA N.º 118/2015, SÉRIE I DE 2015-06-19Revoga a Portaria n.º 348/98, de 15 de junho, que aprova os princípios e normas das boas práticas de distribuição de medicamentos de uso humano e de medicamentos veterinários Read more
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WHO publishes final Guideline for Hold-Time StudiesAfter the WHO had released the second draft of the guideline for the design of hold time studies in March already, it now released the final version as part of the Technical Report Series 992. Read more
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Integrated surveillance of Noncommunicable diseases (iNCD); A European Union-WHO project
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Applying regulatory science to neonates: launch of the International Neonatal Consortium (INC)
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EMA getting ready for the publication of clinical dataThe European Medicines Agency (EMA) will hold a webinar on Wednesday 24 June to update stakeholders on the implementation of its policy on publication of clinical data. Read more
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Nota Informativa sobre BiocidasA partir de 1 de setembro de 2015, um produto biocida que contenha uma substância ativa cujo fornecedor da substância ou do produto não estiverem incluídos na lista elaborada pela Agência Europeia dos Químicos (ECHA), de acordo com o artigo 95.º do Regulamento (UE) n.º 528/2012, para o tipo de produto em causa, não pode ser disponibilizado no mercado nacional, mesmo que autorizado, ou notificado, pela autoridade competente nacional de acordo com as regras do período transitório. Read more
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The European Medicines Agency (EMA) has launched user-acceptance testing of updated electronic application forms (eAF) for centralised procedures of initial marketing authorisations, variations and renewals for human and veterinary medicines. Companies are invited to take part in the exercise and provide feedback on user experience with the updated forms. Read more
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Concept paper on the revision of the guideline on quality of herbal medicinal products/traditional herbal medicinal productsA simplified registration procedure was established for traditional herbal medicinal products (THMPs) for human use with Directive 2004/24/EC of the European Parliament and of the Council. Herbal medicinal products (HMPs) contain exclusively as active ingredients one or more herbal substances or herbal preparations or combinations thereof. Read more
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European Medicines Agency pre-authorisation procedural advice for users of the centralised procedureThis integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the pre-submission guidance for access to the hyperlinked information. Read more
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New USP Chapter on the Integrity of Pharmaceutical PackagingThe USP has described the future requirements for the integrity of pharmaceutical packaging in the Pharmacopeial Forum. New proposals about the content have been published - now in form of 4 general chapters on the integrity of packaging materials. Read more
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Standard operating procedure for annual review of VeDDRA list to be used in EudraVigilance VeterinaryThis document describes the steps taken to invite comments from national competent authorities and interested parties and to subsequently update the Combined VeDDRA1 list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (VMPs) used in the electronic reporting of adverse events to VMPs via EudraVigilance Veterinary (EVVet). The list shall be reviewed and updated annually. Read more
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PORTARIA N.º 150/2015 - DIÁRIO DA REPÚBLICA N.º 101/2015, SÉRIE I DE 2015-05-26Aprova os critérios de fixação da contribuição regulatória e das taxas de registo e as isenções, no âmbito da prossecução das atribuições pela Entidade Reguladora da Saúde, bem como os montantes, critérios de fixação das taxas de licenciamento e as isenções, no âmbito do regime jurídico que ficam sujeitos a abertura, a modificação e o funcionamento dos estabelecimentos prestadores de cuidados de saúde e revoga a Portaria n.º 52/2011, de 27 de janeiro Read more
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Ibuprofeno e dexibuprofeno - recomendações de segurançaO Grupo de Coordenação (CMDh) adotou as recomendações, de minimização do risco de problemas cardiovasculares, do Comité de Avaliação do Risco em Farmacovigilância (PRAC) da Agência Europeia do Medicamento (EMA) relativas aos medicamentos contendo ibuprofeno e dexibuprofeno, decorrentes da finalização da revisão de segurança divulgada na circular informativa N.º 063/CD/8.1.7 de 13/04/2015. Read more
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FDA finalizes Guidelines for BiosimilarsThe FDA issued the final version of three biosimilar guidance documents related to the BPCI Act from 2009. Read more
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Guidance for implementation of eligibility requirementsThis guidance aims at helping organisations that have been granted eligibility prior to the implementation of the revised criteria adopted in June 2014 (EMA/161137/2011 rev 1) as well as new applicants to understand what is expected from them in their efforts to comply with current requirements. The information contained therein should also support future re-assessments, as part of the annual financial re-evaluation and the two-yearly full re-evaluation of an organisations eligibility. Read more
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List of centrally authorised products requiring a notification of a change for update of annexesParallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing authorisation once a year in their annual update application, except in cases related to safety or quality issues. The following table lists the centrally authorised products for which the EMA requires a notification of change before implementation. Read more
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedureThis integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the post-authorisation guidance for access to the hyperlinked information. Read more
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Nota Informativa CEIC sobre o fornecimento do Medicamento Experimental (ME) durante e após conclusão do ECO fornecimento do ME no contexto de ensaios clínicos está previsto na Lei 21/2014 de 14 de abril, no seu artigo 23.º (Fornecimento gratuito e uso compassivo). A CEIC pretende com a " Nota Informativa CEIC sobre o fornecimento do medicamento experimental (ME) durante e após conclusão do EC"esclarecer o seu entendimento acerca do conteúdo deste artigo. Read more
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EFPIA Welcomes WHO Statement on Clinical Trials Data DisclosureEFPIA welcomes theWorld Health Organizations Statement on Public Disclosure of Clinical Trial Results and is supportive of its assertion that the registration of all interventional trials is a scientific, ethical and moral responsibility. Read more
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ECA and PQG publish Chapter 6 of the interpretation of the EU GDP GuidelineThe ECA Foundation and the Pharmaceutical Quality Group (PQG) have been working on the interpretation of different chapters of the EU GDP Guideline. Now the group has finalized the work on chapter 6 - Complaints, Returns, Suspected Falsified Medicinal Products & Medicinal Product Recalls. Read more
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Responses to the public consultation on the revision of Annex 15: Qualification and ValidationResponses to the public consultation on the revision of Annex 15: Qualification and Validation Read more
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Standard operating procedure for processing of annual update notifications for parallel distributionThe purpose of this SOP is to define the procedure for processing the annual update notifications for parallel distribution in a consistent way. Read more
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Standard operating procedure for management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal productsTo enable a transparent procedure for the management of periodic safety update reports (PSURs) for centrally authorised veterinary medicinal products following the granting of a central marketing authorisation by the European Commission and to ensure timely submission and assessment of the PSURs as well as the follow-up of the conclusions and recommendations of the Committee for Medicinal Products for Veterinary Use (CVMP). Read more
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Quality of medicines questions and answers: Part 2These questions and answers address a number of questions that have been brought to the attention of the Joint Committee for Medicinal Products for Human Use / Committee for Medicinal Products for Veterinary Use Quality Working Party (QWP) by marketing-authorisation holders (MAHs) or European Economic Area (EEA) competent authorities, on matters related to the quality of medicines. They have been developed and are maintained by the QWP. Read more
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List of centrally authorised products requiring a notification of a change for update of annexesParallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing authorisation once a year in their annual update application, except in cases related to safety or quality issues. The following table lists the centrally authorised products for which the EMA requires a notification of change before implementation. Read more
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PEDIDO DE AVALIAÇÃO PELA CEIC DA CLASSIFICAÇÃO DE ESTUDOS COMO SENDO "ESTUDOS COM INTERVENÇÃO" OU "ESTUDOS SEM INTERVENÇÃO"
Com a entrada em vigor da Portaria 63/2015 de 5 de março, os pedidos de classificação dos estudos carecem de avaliação formal pela CEIC e respetivo pagamento.
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European Medicines Agency post-authorisation procedural advice for users of the centralised procedureThis integrated version has been created for printing purposes only. Please refer to the individual question & answers as published in the post-authorisation guidance for access to the hyperlinked information. Read more
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Update of the USP Requirements for Packaging Materials made of PlasticsIn the Pharmacopeial Forum the USP has described the future requirements for packaging materials made of plastics. The original proposals were now revised, and new proposals were published with regard to the structure and content of the General Chapters on packaging materials made of plastics. For more information please see the Update of the USP Requirements. Read more
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Fecho - Feriado Nacional
A Phagecon informa que as suas instalações estarão fechadas na próxima sexta-feira, 01 de maio de 2015, devido a feriado nacional, reabrindo segunda-feira, dia 04 de maio de 2015.
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Excipients labellingThe European Medicines Agency (EMA) publishes background documents on excipients to be included in the label and package leaflet of human medicines. Read more
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New industry stakeholder platform on the operation of the centralised procedureThis is the first event in a series of upcoming, semi-annual meetings between regulators and representatives of industry stakeholder organisations. It aims to provide an opportunity for both general updates and more focused discussions on specific processes or issues to support continuous improvement, and generally to foster a constructive dialogue with industry stakeholders. The meeting is providing an update on the current operations, achievements so far, and planned improvements. Particular focus is on the interface in interactions with the applicant during evaluation procedures as well as the management of variations. Registration by invitation only. Registration closed. Read more
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Concept paper on the development of a guideline on quality and equivalence of topical productsDraft: consultation open Read more
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The new requirements of the "Guidelines on the formalised risk assessment for excipients"The most important document so far as concerns "GMP for excipients" was published in the Official Journal of the European Union this year on 21 March. It has the somewhat ponderous title Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (document classification: 2015/C 95/02). We reported on this in our news EU Commission issues two final Guidelines: GMP for Excipients and GDP for APIs. Read more
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Fecho
A Phagecon informa que as suas instalações estarão fechadas na próxima sexta-feira, 03 de abril de 2015, devido a feriado nacional, reabrindo segunda-feira, dia 06 de abril de 2015.
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Inspeção - GVK Biosciences
O INFARMED, I.P. publicou hoje, no seu site, um Comunicado de Imprensa sobre a inspeção na GVK Biosciences.
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Período festivo de Natal e Ano Novo
A Phagecon vem por este meio comunicar a todos os parceiros que irá estar encerrada no período de 24 de dezembro de 2014 a 4 de Janeiro de 2015, para férias de Natal e Ano Novo.
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Fecho
A Phagecon informa que as suas instalações estarão fechadas na próxima segunda-feira, 08 de dezembro de 2014, devido a feriado nacional, reabrindo terça-feira, dia 09 de dezembro de 2014.
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Fecho
A Phagecon informa que as suas instalações estarão fechadas amanhã, 15 de agosto de 2014, devido a feriado nacional, reabrindo segunda-feira, dia 18 de agosto de 2014.
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Fecho
A Phagecon informa que as suas instalações estarão fechadas amanhã, 04 de julho de 2014, devido a feriado municipal, reabrindo segunda-feira, dia 07 de julho de 2014.
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Regulamento (UE) n º 658/2014 do Parlamento Europeu e do Conselho de 15 de maio de 2014 relativo às taxas de farmacovigilância
Regulamento (UE) n º 658/2014 do Parlamento Europeu e do Conselho de 15 de maio de 2014 relativo às taxas cobradas pela Agência Europeia de Medicamentos para a realização de actividades de farmacovigilância no que respeita aos medicamentos para uso humano.
Estas taxas serão cobradas aos titulares de autorização de introdução no mercado, cujos medimentos sejam objecto de tais procedimentos. Estas taxas não são aplicáveis aos procedimentos realizados a nível da União para que a avaliação foi iniciada antes de 26 agosto de 2014. 2.Taxa anual:
Esta taxa será aplicada a partir de 1 julho de 2015. Adicionalmente, o presente regulamento regula as taxas que são cobradas pela EMA. Assim, aos titulares de autorização de introdução no mercado não deve ser cobrada duas vezes a mesma actividade de farmacovigilância (por exemplo, a submissão de estudos PASS a outra autoridade competente). A Phagecon preparou um quadro comparativo em Português com o tipo de serviços e respectivas taxas tendo em consideração as variáveis descritas implicadas em cada uma das actividades de Farmacovigilância. Este poderá ser visto clicando no link acima ou colando o seguinte link no seu navegador: http://www.phagecon.pt/homepage/userfiles/downloads/Noticia_Tabela_PT.pdf Read more
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Fecho
A Phagecon informa que as suas instalações estarão fechadas amanhã, 10 de junho de 2014, devido a feriado nacional, reabrindo quarta-feira, dia 11 de junho de 2014.
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Fecho
A Phagecon informa que as suas instalações estarão fechadas amanhã, 18 de abril de 2014, devido a Férias de Páscoa, reabrindo segunda-feira, dia 21 de abril de 2014.
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Implementação do acordo ortográfico na base de dados Standard Terms
A Phagecon informa que foi publicada, na base de dados Standard Terms da Comissão da Farmacopeia Europeia, uma revisão dos termos, em Português, com vista a implementar o acordo ortográfico atualmente em vigor.
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Eudravigilance Downtime
A EMA informou que vai, na semana de 17 de Março, iniciar procedimentos de manutenção do sistema EudraVigilance, pelo que a EudraVigilance Web Application (EVWEB PRODUCTION), incluíndo a Pós-Função, irá estar indisponível de segunda-feira, 17 de Março, a partir das 17:30h até quarta-feira, 19 de Março às 21:00h.
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Alteração às Comparticipações
A Phagecon, na sequência da Portaria nº45/2014, de 21 de fevereiro, retificada pela Declaração de Retificação nº11-A/2014, publica uma tabela comparativa, com as alterações aos grupos e subgrupos farmacoterapêuticos comparticipados, bem como uma listagem de medicamentos que perdem a comparticipação.
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Comunicação prévia de Congressos, Simpósios, Ações ou eventos científicos ou de divulgação de medicamentos - patrocínios no âmbito do n.º 1 do artigo
A Phagecon informa que o INFARMED I.P., na sequência das alterações ao artigo 159.º do Decreto-Lei n.º 176/2006, de 30 de agosto, pelo Decreto-Lei n.º 128/2013, de 5 de setembro, esclarece que:
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Implementação das recomendações do PRAC - atualização
As recomendações de segurança do Comité de Avaliação do Risco em Farmacovigilância (PRAC) da EMA, adotadas na sequência da avaliação de sinais são mensalmente publicadas na página eletrónica da EMA.
A submissão de qualquer alteração deverá ser feita no prazo de 60 dias após a recomendação do PRAC (PRAC recommendations on safety signals), exceto quando outro calendário for indicado. Read more
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Decreto-Lei nº19/2014, de 5 de fevereiro
O INFARMED I.P. publicou no dia 5 de fevereiro o Decreto-Lei 19/2014 que vem alterar o Decreto-Lei nº48-A/2010, de 13 de maio, na sua redação atual e o Decreto-Lei nº112/2011, de 29 de novembro, na sua redação atual. No decorrer destas modificações legislativas verificam-se alterações ao regime geral de comparticipações do Estado aos medicamentos, nomeadamente quanto aos medicamentos a incluir nos escalões de comparticipação, quanto à evidência de eficácia e efetividade e quanto ao valor mínimo do PVP dos medicamentos genéricos. Em segunda instância este Decreto-Lei vem ainda trazer alterações quanto às margens de comercialização para armazenistas e farmácias.
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Decreto-Lei n.º 19/2014. de 2014-02-05
A Phagecon informa que foi publicado em Diário da Republica o Decreto-Lei n.º 19/2014, o qual procede à quarta alteração ao Decreto-Lei n.º 48-A/2010, de 13 de maio, que aprova o regime geral das comparticipações do Estado no preço dos medicamentos, e à terceira alteração ao Decreto-Lei n.º 112/2011, de 29 de novembro, que aprova o regime da formação do preço dos medicamentos sujeitos a receita médica e dos medicamentos não sujeitos a receita médica comparticipados.
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EMA anuncia próximos passos para a manutenção de informações sobre medicamentos autorizados pelos Titulares de Autorização de Introdução no Mercado
A Agência Europeia de Medicamentos (EMA) divulgou hoje uma orientação para apoiar os titulares de AIM de atualizar as informações sobre os medicamentos autorizados que tenham sido apresentados à Agência, em conformidade com o Artigo 57 (2) da legislação de Farmacovigilância de 2010.
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Transparência e Publicidade
Na sequência das alterações ao artigo 159.º do Decreto-Lei n.º 176/2006, de 30 de agosto, pelo Decreto-Lei n.º 128/2013, de 5 de setembro, o INFARMED esclarece:
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Descontos aos utentes no preço dos medicamentos
Na sequência da Circular Informativa n.º 105/CD/8.1.6. de 10/05/2013, o INFARMED esclarece o seguinte:
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Portal SIEXP
O INFARMED lançou uma Circular Informativa relativa ao funcionamento do Portal SIEXP, onde serão notificados todos os dados de exportação, comércio intracomunitário e consumos de uma listagem de medicamentos, publicada na página desta novidade do INFARMED.
A transação apenas poderá ser efetuada caso o Infarmed não se pronuncie no prazo de 3 dias úteis após a notificação, pela sua proibição, no todo ou em parte. Consumos Todos os intervenientes no circuito do medicamento – Titulares de autorização de introdução no mercado (AIM), Distribuidores por Grosso e Farmácias – deverão reportar os consumos destes medicamentos, nas seguintes condições:
Para permitir a adaptação de todas as entidades, estabeleceu-se um período transitório de adequação, que terminou no dia 31 de dezembro de 2013. Pelo que, à presente data, todas as entidades estão obrigadas a cumprir o disposto nas Deliberações n.º 2100/2013, de 6 de novembro, e n.º 2092/2013, de 5 de novembro, e o conteúdo da presente Circular. Read more
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Revisão anual do preço de medicamentos genéricos
A Portaria nº 4/2012 de 2 de janeiro, define as regras para a revisão dos preços de medicamentos, nomeadamente, o artigo 6º define as regras para a revisão anual do preço dos medicamentos genéricos.
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Manutenção do Sistema EudraVigilance
A Agência Europeia do Medicamento (EMA) informou que vai proceder a uma manutenção no sistema EudraVigilance de 10 a 11 e 17 a 18 de Janeiro. Durante estes períodos o sistema vai estar indisponível entre as 17:30h de sexta-feira até às 21:00h de sábado.
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Revisão anual de preços do mercado hospitalar - Update
A Phagecon informa que, devido ao prazo estipulado pelo INFARMED, I.P. para a apresentação da revisão anual de preços do mercado hospitalar (27/12/2013), a Autoridade Competente identificou os medicamentos aos quais se aplica a Circular Informativa Nº289/CD/8.1.6 e enviou um e-mail apenas aos titulares de autorização de introdução no mercado dos medicamentos que requerem a revisão de preços dos medicamentos de mercado hospitalar.
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Revisão anual de preços do mercado hospitalar
Foi publicada, no site do INFARMED a Circular Informativa Nº289/CD/8.1.6, referente à revisão anual de preços do mercado hospitalar.
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Alteração do Código Deontológico da Apifarma
O Código Deontológico da Apifarma Para as Práticas Promocionais da Indústria Farmacêutica e Para as Interações com os Profissionais de Saúde que entrou em vigor em Janeiro de 2012, foi alterado pelo novo Código Deontológico da Apifarma Para as Práticas Promocionais da Indústria Farmacêutica e Para as Interações com os Profissionais de Saúde e Instituições, Organizações ou Associações Constituídas por Profissionais de Saúde, a entrar em vigor em 2014.
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Período de Natal
A Phagecon vem por este meio comunicar que irá estar encerrada no período de 26 a 31 de dezembro de 2013 para férias do Natal.
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Novo regime aduaneiro de Angola
Foi publicada a nova Pauta Aduaneira dos Direitos de Importação e Exportação de Angola (Decreto Legislativo Presidencial 10/13 de 22 de Novembro) a qual revoga a anterior Pauta de 2008 e altera o regime jurídico aduaneiro de Angola, designadamente:
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Revisão Anual de Preços
O Decreto-Lei n.º 112/2011, de 29 de novembro, na redação dada em último lugar pelo Decreto-Lei n.º 34/2013, de 27 de fevereiro, estabelece o regime de preços dos medicamentos. O n.º 2 do artigo 6.º do mesmo diploma prevê a definição anual, até 15 de novembro do ano precedente, por portaria do membro do Governo responsável pela área da saúde, dos três países de referência com base nos quais se procede à fixação dos preços.
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Recomendações do PRAC decorrentes da avaliação de sinais de segurança
No âmbito da farmacovigilância, a avaliação de sinais de segurança, reveste-se de um papel essencial para garantir informação actualizada quanto a riscos e benefícios dos medicamentos.
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MANHÃS INFORMATIVAS DO INFARMED, I.P. Gestão de Acessibilidade do Medicamento (GAM)
A nova plataforma GAM tem como finalidade a submissão e gestão dos pedidos de comparticipação e de avaliação prévia de Medicamentos de Uso Humano. Esta plataforma permite que todo o processo seja gerido exclusivamente em ambiente online.
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Estatuto do Medicamento: destaque das alterações mais relevantes (análise em tabela comparativa)
O Decreto-Lei nº 128/2013, de 5 de setembro, procede à oitava alteração ao Decreto-Lei n.º 176/2006, de 30 de agosto, que estabelece o regime jurídico dos medicamentos de uso humano.
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Decreto-Lei n.º 103/2013 de 26 de julho
A Phagecon informa que foi publicado em Diário da Republica o Decreto-Lei n.º 103/2013, de 26 de julho, que procede à terceira alteração ao Decreto-Lei n.º 48-A/2010, de 13 de maio, que aprova o regime geral das comparticipações do Estado no preço dos medicamentos.
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Casos de reações adversas a medicamentos
De acordo com requisitos legais nacionais e europeus vigentes, os casos de reações adversas a medicamentos (RAM) devem ser notificados aos vários parceiros (Titulares de AIM, Autoridades Nacionais Competentes e Agência Europeia do Medicamento). Esta notificação por parte dos Titulares de AIM é, desde 20 de novembro de 2005, efetuada obrigatoriamente por transmissão eletrónica.
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Validação da informação da Infomed
Após diversos pedidos de correção à Infomed, o Infarmed disponibiliza, através da base de dados, um acesso restrito para que cada titular de autorização de introdução no mercado (AIM) possa validar a informação referente à comercialização, preços e comparticipações dos seus medicamentos do mês atual e do mês seguinte.
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Alterações aos termos da Autorização de Introdução no Mercado
Irão ocorrer duas grandes alterações em Portugal no que diz respeito à submissão de alterações aos termos da Autorização de Introdução no Mercado de medicamentos em Portugal.
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Diretiva sobre Medicamentos Falsificados
A partir do dia 2 de Julho de 2013 todos os Princípios Ativos que sejam fabricados fora da União Europeia (UE) e que são importados para a UE têm de ser devidamente acompanhados por uma confirmação por escrito por parte da entidade reguladora do país de exportação que garanta que os requisitos relativos às Boas Práticas de Fabrico (BPF) e controlo da fábrica de produção são equivalentes aos que são utilizados na UE.
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Circular Informativa do INFARMED, I.P. Nº 145/CD/8.1.6 de 25/06/2013
Com a transposição da Diretiva nº 2010/84/EU, do Parlamento Europeu e do Conselho, de 15 de Dezembro, para o direito nacional através do Decreto-Lei nº 20/2013, de 14 de fevereiro, passou a ser obrigatória a nomeação de uma pessoa de contacto para questões de farmacovigilância devendo reportar à pessoa responsável pela Farmacovigilância. A pessoa de contacto precisa de reunir as seguintes condições:
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Plano de Gestão do Risco e Resumo de Sistema de Farmacovigilância - Pedidos de AIM e AIM autorizadas por procedimento nacional
O INFARMED, I.P. publicou na passada sexta-feira a Circular Informativa N.º 120/CD/8.1.6 que define um período de transição mais alargado para implementação dos novos requisitos da farmacovigilância, relativamente ao período anteriormente estabelecido pela Circular Informativa n.º036/CD/8.1.6, de 8 de março. Não existe obrigatoriedade de apresentação de um Plano de Gestão do Risco. Contudo, o Infarmed pode solicitá-lo, sempre que tal se justifique. Não existe obrigatoriedade de apresentação de um Plano de Gestão do Risco. Contudo, o Infarmed pode solicitá-lo, sempre que tal se justifique. Não existe obrigatoriedade de submissão do Resumo do Sistema de Farmacovigilância no decurso da avaliação do pedido. Contudo, os requerentes podem aproveitar esta ocasião para o anexar. Se a AIM for concedida sem a inclusão do Resumo do Sistema de Farmacovigilância, este terá de ser submetido na renovação ou através de uma alteração aos termos da AIM, até 21 de julho de 2015, consoante a que ocorra primeiro. AIM cujos pedidos foram submetidos em ou após 21 de julho de 2012 e já foram concedidas O titular da AIM tem de submeter as alterações aos termos da AIM para aprovação do Resumo do Sistema de Farmacovigilância e do Plano de Gestão do Risco até 27 de dezembro de 2013, sob pena de revogação da AIM concedida. Pedidos de AIM em avaliação submetidos entre 21 de julho de 2012 e 14 de fevereiro de 2013a) Processos em fase final de avaliação Entende-se como estando em fase final de aprovação os pedidos de AIM que tenham sido presentes ou se encontrem agendados para discussão no plenário da Comissão de Avaliação de Medicamentos. Estes processos serão concluídos sem inclusão do Resumo do Sistema de Farmacovigilância e do Plano de Gestão do Risco.O titular da AIM tem de submeter as alterações aos termos da AIM para aprovação do Resumo do Sistema de Farmacovigilância e do Plano de Gestão do Risco até 27 de dezembro de 2013, sob pena de revogação da AIM concedida. b) Processos em avaliaçãoPara os processos em que não tenha sido ainda iniciada a fase final de aprovação, os requerentes podem submeter o Resumo do Sistema de Farmacovigilância e o Plano de Gestão do Risco dentro do prazo máximo de 90 dias consecutivos após a publicação da presente circular. Aos processos que entretanto tenham atingido a fase final de avaliação, sem que tenham sido apresentados o Resumo do Sistema de Farmacovigilância e do Plano de Gestão do Risco, aplica-se a alínea anterior. Pedidos de AIM submetidos em ou após 15 de fevereiro de 2013 ainda em avaliação
Os requerentes têm de entregar o Plano de Gestão do Risco e o Resumo do Sistema de Farmacovigilância dentro do prazo máximo de 90 dias consecutivos após a publicação da presente circular. A não entrega da documentação no referido prazo constituirá motivo de indeferimento do pedido. Pedidos de AIM submetidos em 1 de julho de 2013A não apresentação do Plano de Gestão do Risco e do Resumo do Sistema de Farmacovigilância aquando a submissão do pedido, constituem motivo de invalidação do pedido. A Phagecon está disponível para esclarecer e apoiar os seus clientes e parceiros em qualquer necessidade relacionada com a supracitada alteração legislativa. Não hesite em nos contactar! Read more
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Novos requisitos de notificação para os titulares de autorizações de introdução no mercado
Foi ontem (05-06-2013) publicada no site da EMA uma notícia, com base nas alterações à legislação de farmacovigilância, sobre as novas exigências de notificação aos titulares de autorização de introdução no mercado. Alguns acontecimentos na área de farmacovigilância na União Europeia, vieram demonstrar a necessidade de um procedimento automático a nível Europeu em casos de problemas específicos de segurança de modo a garantir que uma questão é avaliada e tratada em todos os Estados-Membros em que o medicamento é autorizado. Assim, as alterações abaixo descritas, contribuem para reforçar a proteção da saúde do doente autorizando a Agência a tomar decisões apropriadas, incluindo desencadear procedimentos de recurso, quando necessário. Neste sentido, os titulares de autorizações de introdução no mercado de medicamentos humanos terão agora de declarar as razões que os levaram a realizar quaisquer das ações abaixo indicadas à Agência Europeia de Medicamentos (EMA), de acordo com as alterações à legislação de farmacovigilância de 2010 da União Europeia (UE): descontinuação ou suspensão temporária ou permanente da comercialização de um medicamento;retirada de um medicamento do mercado; um pedido para revogação de uma autorização de introdução no mercado; a intenção para não aplicar a renovação de uma autorização de introdução no mercado. Estas alterações foram adotadas em Outubro de 2012 e são aplicáveis aos medicamentos centralizados a partir de 5 de Junho de 2013: Para os medicamentos autorizados por procedimento nacional, estas alterações terão vínculo obrigatório a partir de 28 de Outubro de 2013. As alterações estipulam que, para além da notificação destas ações, os titulares de autorização de introdução no mercado têm a obrigação clara de declarar as razões para as tomar, em especial quando estas são baseadas em qualquer uma das seguintes justificações: o medicamento é prejudicial;o medicamento carece de eficácia terapêutica; o equilíbrio do risco-benefício do medicamento não é favorável; a composição qualitativa e quantitativa do medicamento não está de acordo com a declarada; foram identificadas questões de fabrico ou de inspeção. A maioria dos requisitos de notificações supracitados já se aplicam para medicamentos centralizados autorizados como parte das directrizes processos da Agência. Para medicamentos centralizados autorizados, os titulares de autorização de introdução no mercado devem continuar a seguir os processos descritos na diretriz atual sobre notificação de comercialização e de descontinuação. Devem continuar a notificar a Agência imediatamente através do líder da equipa do produto nomeado, da: retirada de um medicamento do mercado por razões de segurança;intenção de requerer a revogação de uma autorização de introdução no mercado; intenção para não aplicar a renovação de uma autorização de introdução no mercado. Revogações devido a questões de qualidade, fabrico ou inspeção devem ainda ser notificadas através do ponto de contacto para defeitos de qualidade e recolhas. Para medicamentos autorizados nacionalmente, as alterações à legislação significam que os titulares de autorização de introdução no mercado irão necessitar de notificar a EMA, para além do Estado-Membro em que o medicamento está autorizado, quando estas ações são tomadas com base em qualquer uma das justificações listadas acima. Realça-se que estas obrigações também se aplicam quando a ação baseada nestas justificações tem lugar num país terceiro (um país fora do Espaço Económico Europeu). A EMA está a trabalhar em conjunto com os Estados-Membros para definir um processo de notificação comum para os medicamentos, para os medicamentos aprovados pelos procedimentos acima descritos. Os documentos de orientação da EMA deverão estar actualizados de acordo com os novos requisitos a 28 de Outubro de 2013. Para consulta da noticia, por favor, siga o link acima indicado. Read more
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Rascunho sobre os Biossimilares
A primeira guideline sobre os Biossimilares foi emitida pela EMA em 2005 e levou à aprovação de 14 medicamentos enquanto outros 5 estão atualmente em avaliação. A EMA decidiu agora rever esta guideline e publicou um rascunho para consulta pública. Esta revisão tem como objetivo: 1. Fornecer clarificação respeitante à terminologia dos biossimilares;2. Providenciar uma maior clareza sobre os princípios da biossimilaridade, incluindo os aspetos de segurança e eficácia; 3. Clarificar requisitos que digam respeito à posologia, via de administração e formulação de biossimilares; 4. Aspetos globais escolha do produto de referência quando se conduz estudos clínicos e não clínicos. Uma das principais alterações é que agora é possível para os promotores de biossimilares compararem o seu biossimilar em certos estudos clínicos e em estudos não clínicos in vivo com um comparador autorizado fora do EEE desde que este comparador esteja autorizado por uma autoridade regulamentar com padrões científicos e regulamentares semelhantes aos da EMA. Este rascunho da guideline revista está disponível para consulta pública até 31 de outubro de 2013 PhageconServiços e Consultoria Farmacêutica, Lda. | Pharmaceutical Services and Consulting, Ltd. Rua Capitão Luís Gonzaga, nº 74 | Santo António dos Olivais | 3000 - 095 Coimbra | PORTUGAL Tel.: +351. 239 853 350 | Fax: +351. 239 853 359 E-mail: phagecon@phagecon.pt | URL: www.phagecon.pt Read more
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Despacho nº 6021/2013, Diário da República, 2ª série Nº89 9 de Maio de 2013
Pelo disposto no nº5 do artigo 4º do DL nº19/2010 na redacção dada pelo DL nº 108/2011 de 17 de Novembro a Serviços Partilhados do Ministério da Saúde, E.P.E. (SPMS, E.P.E) é considerada central de compras. No âmbito das suas competências SPMS, E.P.E levou a efeito um concurso público (publicitado em DR, 2ª série nº 104, de 29/05/2012, agora concluído) para o CPA para aprovisionamento de: 1. Medicamentos Analgésicos2. Medicamentos Antipiréticos 3. Medicamentos Antidepressores No decorrer deste concurso ficou determinado que: 1. A SPMS, E.P.E divulga agora no site www.catalogo.minsaude.pt todas as características dos produtos abrangidos pelo CPA para os medicamentos supracitados;2. Para as Instituições e Serviços do Serviço Nacional de Saúde, salvo dispensa conferida por Despacho do membro do governo responsável pela área da Saúde, fica estabelecida a obrigatoriedade da aquisição ao abrigo do CPA presente no presente Despacho; 3. A aquisição deve ser feita com respeito do critério do mais baixo preço unitário constante do caderno de encargos; 4. As condições de fornecimento devem ser comunicados à SPMS, E.P.E; 5. Os CPA ao abrigo do CP 2012/44 têm a duração de um ano, sendo prolongados até ao máximo de 3 anos; 6. As alterações às condições de aprovisionamento entram em vigor no dia seguinte ao da respectiva autorização pela SPMS, E.P.E; Para verificar o catálogo resultante do concurso 2012/44 Analgésicos, Antipiréticos e Anti depressores, por favor consulte o link presente na nossa notícia. A Phagecon está disponível para esclarecer e apoiar os seus clientes e parceiros em qualquer necessidade relacionada com a supracitada alteração legislativa. Não hesite em nos contactar! PhageconServiços e Consultoria Farmacêutica, Lda. | Pharmaceutical Services and Consulting, Ltd. Rua Capitão Luís Gonzaga, nº 74 | Santo António dos Olivais | 3000 - 095 Coimbra | PORTUGAL Tel.: +351. 239 853 350 | Fax: +351. 239 853 359 E-mail: phagecon@phagecon.pt | URL: www.phagecon.pt Read more
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Redução das Taxas para Medicamentos Órfãos
A EMA cancelou o procedimento em que os promotores de medicamentos conhecidos como órfãos tinham que informar sobre a sua intenção de submeter uma aplicação de forma a serem elegíveis a uma redução das taxas (no protocolo de assistência, a submissão da autorização de introdução de mercado e inspeções). Como resulto, a Agência não necessita agora de informações adicionais para avaliar a elegibilidade de medicamentos órfãos para a redução da taxa. Esta alteração tem várias consequências: 1. O documento Conselhos para o Procedimento de reduções das taxas para os medicamentos designados como órfãos foi retirado do site da EMA2. A SOP (SOP/H/3048) sobre o processo de redução das taxas sobre medicamentos órfãos está agora obsoleta. A Phagecon está disponível para esclarecer e apoiar os seus clientes e parceiros em qualquer necessidade relacionada com a supracitada alteração legislativa. Não hesite em nos contactar! PhageconServiços e Consultoria Farmacêutica, Lda. | Pharmaceutical Services and Consulting, Ltd. Rua Capitão Luís Gonzaga, nº 74 | Santo António dos Olivais | 3000 - 095 Coimbra | PORTUGAL Tel.: +351. 239 853 350 | Fax: +351. 239 853 359 E-mail: phagecon@phagecon.pt | URL: www.phagecon.pt Read more
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Documento de reflexão sobre o uso de metil- e propilparabeno como excipientes nos medicamentos de uso humano para via oral.
A EMA publicou um rascunho de uma guideline para consulta pública sobre o uso de metil- e propilparabeno como excipientes nos medicamentos para uso humano para via oral. Os esteres para-hidroxibenzoatos e os seus sais sódicos, normalmente conhecidos como parabenos, têm sido utilizados durante muitas décadas como conservantes antimicrobianos em cosméticos, produtos alimentares e formulações farmacêuticas. Os parabenos são eficazes com intervalo de pH abrangente com um elevado espetro de atividade antimicrobiana e são também eficazes contra fungos e leveduras. A atividade antimicrobiana aumenta com a duração aumentada da cadeia alquil para os parabenos metilo, etilo, propilo e butilo frequentemente utilizados, e tem sido notificada sinergia entre os parabenos. Nas formulações farmacêuticas orais, as associações de metilparabeno e propilparabeno são utilizadas com concentrações que normalmente alternam entre 0,015 a 0,2% para o metilparabeno e 0,02% a 0,06% para o propilparabeno. Outros parabenos como o etilparabeno e o butilparabeno são também utilizados na indústria farmacêutica em menor quantidade. Este último é predominantemente utilizado em formulações farmacêuticas para a via cutânea. O documento de reflexão atual foca-se nos parabenos mais frequentemente utilizados (metil- e propilparabeno), mencionando que a CHMP concluiu que os dados disponíveis dos estudos animais não representam um risco para os humanos. Contudo, são necessários mais dados para avaliar o potencial risco do propilparabeno em crianças com menos de dois anos de idade. Será necessário justificar caso-a-caso o uso de medicamentos que contenham propilparabeno neste grupo etário, pesando a necessidade de tratamento e o potencial risco. O metilparabeno não tem sido associado com efeitos adversos nos órgãos reprodutores masculinos e femininos em ratos jovens ou em estudos de desenvolvimento embrio-fetal. Tal permite concluir que o uso do metilparabeno em formulações orais em concentrações até 0,2% do produto (dentro das concentrações efetivas recomendadas para um conservante) não é uma preocupação para os humanos, incluindo a população pediátrica independentemente do grupo etário. No que diz respeito ao Propilparabeno, foi vista uma certa atividade estrogénica em várias configurações experimentais. Com base nos resultados publicados sobre o sistema reprodutor feminino, foi determinado um NOEL conservador de 250 mg/kg para o propilparabeno. Para crianças com menos de 2 anos, não pode ser determinado um PDE para o propilparabeno devido à incerteza relacionada com a maturação das enzimas que metabolizam o propilparabeno bem como à limitação dos dados animais disponíveis correspondentes a crianças mais jovens. Contudo, as margens de segurança identificadas em adultos e crianças com mais de 2 anos são atualmente tranquilizadoras. Não obstante, são necessários mais dados de exposição ao propilparabeno em crianças com menos de 2 anos. O uso de uma formulação que contenha propilparabeno em crianças muito jovens pode ser justificado caso-a-caso através de uma perspetiva benefício/risco, pesando a necessidade do tratamento e o risco potencial. Esta avaliação deve ter em conta vários fatores tais como a posologia e a concentração de propilparabeno, a duração do tratamento, a gravidade da doença e a disponibilidade de tratamentos alternativos. Um valor para o PDE de 5 mg/kg/dia pode ser calculado para o uso do propilparabeno em adultos e crianças com mais de 2 anos com capacidade metabólica de um adulto. Este rascunho da guideline está disponível para consulta pública até 31 de outubro de 2013. Para consultar este rascunho da guideline, por favor siga a hiperligação disponível acima. PhageconServiços e Consultoria Farmacêutica, Lda. | Pharmaceutical Services and Consulting, Ltd. Rua Capitão Luís Gonzaga, nº 74 | Santo António dos Olivais | 3000 - 095 Coimbra | PORTUGAL Tel.: +351. 239 853 350 | Fax: +351. 239 853 359 E-mail: phagecon@phagecon.pt | URL: www.phagecon.pt Read more
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Novas recomendações sobre o uso de ftalatos como excipientes em medicamentos de uso humano
A EMA publicou hoje uma proposta de guideline para consulta pública sobre o uso de ftalatos como excipientes em medicamentos de uso humano. Este grupo de excipientes é usado num vasto número de formas farmacêuticas orais, sólidas ou liquidas, devido às suas propriedades viscosantes e plastificantes, podendo ser incluídos em formulações de cápsulas de gelatina mole. Os ftalatos mais utilizados em medicamentos de uso humano são o ftalato de dibutilo (DBP), ftalato de dietilo (DEP), ftalato de acetato de polivinilo (PVAP), ftalato de acetato de celulose (CAP), e acetato ftalato de hidroxipropilmetilcelulose (HPMCP). Esta guideline tem como objetivo estabelecer limites nas quantidades usadas destes excipientes nos medicamentos face aos dados de estudos em animais que revelam efeitos adversos reprodutivos e no desenvolvimento em relação às suas propriedades anti androgénicas com a utilização dos ftalatos DBP, DEP e PVAP. Consequentemente, é proposto um limite de 0.01, 4 e 2 mg/kg/dia para os produtos DBP, DEP e PVAP, respectivamente. Os dados atualmente disponíveis para os ftalatos CAP e HPMCP não indicam que a sua presença em medicamentos de uso humano constitua um risco potencial para a saúde humana. As recomendações desta guideline devem ser consideradas como medidas preventivas, na ausência de evidência clínica de efeitos adversos em seres humanos devido ao consumo de ftalatos. Depois da entrada em vigor da guideline, no caso de medicamentos já autorizados, será dado um prazo de três anos para a implementação de mudanças de formulação e consequentes aplicações regulamentares. A presença em medicamentos de DBP, DEP ou PVAP em níveis que dão origem a exposições diárias acima do recomendado, podem ser admitidas excecionalmente, devendo ser avaliadas caso a caso, tendo em consideração a população afectada, a gravidade da doença e a presença de alternativas terapêuticas. A guideline estará disponível para consulta pública até Outubro de 2013. Para consulta da guideline, por favor, siga o link acima indicado. Read more
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Medicamentos sujeitos a monitorização adicional
Existe um conjunto de medicamentos que necessita de uma monitorização especial pelas autoridades regulamentares, aos quais se chamam medicamentos sujeitos a monitorização adicional. ? Este medicamento está sujeito a monitorização adicional. O triângulo preto será usado, a partir do outono de 2013, nos FI dos medicamentos de todos os Estados-membros da EU. Este símbolo não vai constar na embalagem exterior dos medicamentos. Aplicação do triângulo pretoSe um medicamento estiver identificado com o triângulo preto, significa que está a ser alvo de uma monitorização acrescida. Esta situação normalmente ocorre quando existe menos informação disponível, por serem medicamentos novos no mercado ou existir pouca informação sobre a sua utilização a longo prazo, não significando que a sua utilização não seja segura. A denominação de medicamento sujeito a monitorização adicional aplica-se a todos os medicamentos nas seguintes situações: - contêm uma substância ativa nova autorizada na UE após 1 de janeiro de 2011;- Medicamentos biológicos tais como uma vacina ou um medicamento derivado do sangue ou plasma, para os quais exista uma experiência pós-autorização limitada; - têm uma autorização condicional (situações em que o Titular da Autorização de Introdução no Mercado tem de fornecer mais informação sobre o medicamento durante a sua comercialização); - são autorizados sob circunstâncias excecionais (quando existem razões específicas pelas quais o Titular da AIM não consegue fornecer mais informação); - necessitam de estudos adicionais, por exemplo, mais dados sobre a utilização a longo prazo ou sobre uma reação adversa rara observada durante os ensaios clínicos. - sejam alvo de decisão do Comité de Avaliação do Risco em Farmacovigilância (PRAC) da Agência Europeia do Medicamento (EMA). Lista Europeia de medicamentos sujeitos a monitorização adicional A inclusão dos medicamentos na lista pode ocorrer logo após a sua autorização ou em qualquer altura do seu ciclo de vida. Os medicamentos que constam da lista manter-se-ão durante cinco anos ou até decisão em contrário pelo PRAC. Pode existir um desfasamento entre a informação constante da lista e o folheto informativo existente nas embalagens dos medicamentos que se encontram no circuito comercial, pois é necessário substituir estes documentos que se encontram dentro das embalagens dos medicamentos. Aplicação dos conceitos de monitorização adicional e do símbolo- Todos os medicamentos autorizados a partir de 1 de setembro de 2013 e que estejam sujeitos a monitorização adicional já têm de incluir o triângulo preto no FI e no RCM; - Todos os medicamentos autorizados entre janeiro de 2011 e agosto de 2013 dispõem de um período transitório para a atualização dos FI e dos RCM, uma vez que esta legislação afeta apenas os medicamentos autorizados após 1 de janeiro de 2011; - Os materiais educacionais de medicamentos sujeitos a monitorização adicional têm de conter esta informação.Plano de Implementação O triângulo preto estará presente nos RCM e FI dos medicamentos sujeitos a monitorização adicional, a partir do outono de 2013. Para os novos medicamentos, os TAIM deverão começar a utilizar os novos modelos de RCM e FI, caso a opinião do CHMP esteja prevista para abril ou maio de 2013. No caso dos medicamentos cuja opinião do CHMP seja emitida partir de Junho de 2013, os TAIM deverão utilizar os novos modelos. Para os medicamentos que já se encontram autorizados, e para os quais esteja em curso uma alteração ao RCM/FI, os TAIM deverão utilizar os novos modelos, não sendo para o efeito necessário a submissão de uma alteração para introdução desta informação. A utilização dos novos modelos é obrigatória a partir de 1 de Janeiro de 2014, pelo que o TAIM deverá submeter uma alteração tipo IAIN até 31 de Dezembro de 2013 No plano de implementação estará descrito o procedimento regulamentar e o calendário que os TAIM deverão seguir. Read more
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Escoamento de preços de medicamentos decorrentes da revisão anual de preços e decorrente da revogação da dedução de 6%
Na sequência do processo de revisão anual de preços decorrente da aplicação da Portaria nº 91/2013, 28 de Fevereiro, e da revogação da Portaria nº1041-A/2010, de 7 de Outubro, o Infarmed veio, através do envio desta circular, clarificar que se mantém aplicável a Portaria nº4/2012 de 2 de Janeiro, para efeitos de prazo de escoamento: 60 dias para Distribuidores / Grossistas90 dias para Farmácias Durante o período de escoamento devem ser consideradas as seguintes situações: Medicamentos que se encontram nos distribuidores e farmácias no dia 31 de Março Sujeitos a escoamento ao preço descontado, ou seja, o utente deverá continuar a pagar o mesmo valor pelos medicamentos; Medicamentos adquiridos pelos distribuidores e farmácias a partir do dia 1 de Abril, inclusive Deverão ser dispensados ao preço resultante da revisão anual de preços; A Phagecon está disponível para esclarecer e apoiar os seus clientes e parceiros em qualquer necessidade relacionada com a supracitada alteração legislativa. Não hesite em nos contactar! Read more
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Plano de Gestão do Risco e Resumo de Sistema de Farmacovigilância - Pedidos de AIM e AIM autorizadas após 21 de julho de 2012, procedimento nacional
O INFARMED, I.P. publicou ontem a Circular Informativa N.º 036/CD/8.1.6 com o objetivo de esclarecer a aplicação dos requisitos de apresentação do Resumo do Sistema de Farmacovigilância e do Plano de Gestão do Risco aos pedidos de Autorização de Introdução no Mercado (AIM) em avaliação e já autorizados, de acordo com as obrigações em matéria de farmacovigilância por parte dos titulares e requerentes de pedidos de Autorização de Introdução no Mercado (AIM) introduzidas na recente revisão do Decreto-Lei n.º 176/2006, de 30 de agosto. Esclarece a Circular: AIM concedidas antes de 21 de julho de 2012 AIM concedidas após 21 de julho de 2012 Pedidos de AIM em avaliação
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PLATAFORMA DE COMUNICAÇÕES - TRANSPARÊNCIA E PUBLICIDADE
Foi publicado hoje pelo INFARMED, I.P., um documento de PERGUNTAS FREQUENTES relacionado com as comunicações que as entidades abrangidas pelos números 5 e 6 do artigo 159.º da redação atual do Decreto-Lei n.º 176/2006, de 30 de agosto deverão efetuar através da Plataforma de Comunicações Transparência e Publicidade disponível na área de Utilidades Serviços Eletrónicos (http://www.infarmed.pt/portal/page/portal/INFARMED/SERVICOS_ELECTRONIC S).
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Introdução do Símbolo Preto para identificação de medicamentos que estão sujeitos a monitorização adicional.
Ontem, dia 7 de março de 2013, a Comissão adotou um Regulamento de Execução que introduz um Símbolo Preto para identificar medicamentos que estão sujeitos a monitorização adicional. Um triângulo preto invertido '?' irá aparecer no resumo das características do produto e no folheto informativo de certos medicamentos no mercado da UE. O símbolo preto irá permitir que os doentes e os profissionais de saúde identifiquem estes produtos sujeitos a monitorização adicional e o texto que o acompanha irá encorajá-los a notificar reações adversas. A partir de setembro de 2013, o símbolo preto será usado para identificar os referidos produtos farmacêuticos. São eles:
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Esclarecimentos adicionais sobre a revisão anual de preços de 2013
O INFARMED, I.P. publicou no dia 08/03/2013 a Circular Informativa N.º 037/CD/8.1.6 com o objetivo de esclarecer algumas questões relacionadas com a revisão anual de preços de 2013. Salientamos os pontos mais importantes desta Circular: As disposições estabelecidas na Portaria n.º 4/2012, de 2/01 (ainda em vigor), mantêm-se válidas para o ano de 2013, nomeadamente os prazos de escoamento das embalagens e a não aplicação da revisão para os medicamentos com preço inferior a 5. O Quadro-síntese dos medicamentos não genéricos foi recentemente substituído de forma a contemplar a regra dos preços que, pela revisão, teriam de descer para valores inferiores a 5 ficassem no patamar dos 5 . Parecem existir algumas dificuldades na pesquisa de medicamentos nas bases de dados dos países de referência, sobretudo no que respeita à pesquisa por substância ativa. Assim, em caso de dúvida, não se deverá considerar esse comparador no país em causa. Em âmbito da validação por parte do INFARMED, I.P., serão feitas correções, à semelhança de anos anteriores. Esclarecimentos gerais:Os preços nos países de referência a utilizar na comparação são os praticados no 1.º dia de Fevereiro, uma vez que a revisão se processa no mês de março, de acordo com o disposto no art.º 7.o do Decreto-lei n.º 112/2011, de 29 de Novembro. Read more
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Publicação das novas guidelines da União Europeia para as Boas Práticas de Distribuição (2013/C 68/01).
Foram ontem, 7 de março de 2013, publicadas as novas guidelines para as Boas Práticas de Distribuição (BPD) de Medicamentos de Uso Humano da União Europeia (2013/C 68/01). Numa primeira análise, o documento final publicado não aparenta ser significativamente diferente das versões para comentários previamente publicadas.
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Suspeitas de reações adversas não graves que ocorram em território nacional
O INFARMED, I.P. publicou ontem a Circular Informativa N.º 032/CD/8.1.6 com o objetivo de esclarecer o disposto no n.º 11 do artigo 7.º (Disposições Transitórias) do recentemente publicado Decreto-Lei n.º 20/2013, de 14 de fevereiro: Enquanto a Agência não puder garantir as funcionalidades da base de dados Eudravigilance, tal como descritas no artigo 24.º do Regulamento (CE) n.º 726/2004, do Parlamento Europeu e do Conselho, de 31 de março de 2004, os titulares da autorização de introdução no mercado devem, no prazo de 90 dias, a contar do conhecimento, notificar o INFARMED, I.P., de todas as suspeitas de reações adversas não graves que ocorram em território nacional.. Esclarece a Circular que os titulares da AIM só devem comunicar as suspeitas de reações adversas não graves que ocorram em território nacional quando expressamente solicitado pelo Infarmed.A decisão do Infarmed é fundamentada com base no n.º 5 do artigo 2.º da Diretiva 2010/84/UE, de 15 de dezembro de 2010 que permite às autoridades competentes dos Estados-Membros decidir, durante o período de transição, até a base de dados EudraVigilance estar concluída, sobre a obrigatoriedade da notificação das suspeitas de reações adversas sem gravidade que ocorram no território desse Estado-Membro. Read more
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Alterações ao Regime de preços dos Medicamentos
Foram hoje publicadas duas Circulares Informativas pelo INFARMED, I.P. com o objetivo de esclarecer como irá ser processada a revisão anual de preços de 2013 Circular Informativa N.º 032/CD/8.1.6. e quando produzirá efeitos a revogação da Portaria nº 1041-A/2010 (Dedução 6%) Circular Informativa N.º 033/CD/8.1.6. Desta forma salientamos os seguintes pontos:- Os novos preços dos medicamentos não genéricos (ambulatório e hospitalar) decorrentes da revisão devem ser comunicados ao Infarmed até 15 de março e entram em vigor a 1 de abril; - Devem ser utilizados os Formulários, Quadro-síntese e as Instruções para pedidos de aprovação de PVP disponíveis na página online do Infarmed, que entretanto serão atualizados; - Os PVPs resultantes da revisão devem ser notificados através do Sistema de Receitas e Cobrança de Taxas, os Formulários e o Quadro-síntese devem ser enviados por via eletrónica para o endereço aprovação.preco@infarmed.pt; - O pedido de alterações voluntárias de preço para os medicamentos não genéricos pode ser excecionalmente notificado até dia 15 de março em conjunto com a revisão; - A revogação da Portaria n.º 1041 -A/2010, de 7 de outubro que estabelecia uma dedução (6 % do PVP máximo autorizado) a praticar sobre os PVP máximos autorizados dos medicamentos de uso humano comparticipados, só produz efeitos a partir de dia 1 de abril 2013. Não foi ainda avançado pelo Infarmed como se processará a revisão anual de preço dos medicamentos genéricos. Para aceder às referidas Circulares Informativas por favor cole os seguintes links no seu browser. ? Circular Informativa N.º 032/CD/8.1.6. http://www.infarmed.pt/portal/pls/portal/docs/1/8454266.PDF ? Circular Informativa N.º 033/CD/8.1.6. http://www.infarmed.pt/portal/pls/portal/docs/1/8454269.PDF A Phagecon está disponível para esclarecer e apoiar os seus clientes e parceiros em qualquer necessidade relacionada com a supracitada alteração legislativa. Não hesite em nos contactar! Phagecon Serviços e Consultoria Farmacêutica, Lda. | Pharmaceutical Services and Consulting, Ltd. Rua Capitão Luís Gonzaga, nº 74 | Santo António dos Olivais | 3000 - 095 Coimbra | PORTUGAL Tel.: +351. 239 853 350 | Fax: +351. 239 853 359 E-mail: phagecon@phagecon.pt | URL: www.phagecon.pt Read more
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Alterações ao Regime de preços dos Medicamentos
Foi publicado ontem o Decreto-Lei n.º 34/2013, de 27 de fevereiro que procede à alteração do Decreto -Lei n.º 112/2011, de 29 de novembro, diploma que estabelece o regime de preços dos medicamentos. As principais alterações introduzidas por este Diploma são: - São estabelecidos anualmente por Portaria três países de referência da União Europeia considerados para a revisão de preços anual que, face a Portugal, apresentem ou um produto interno bruto per capita comparável em paridade de poder de compra ou um nível de preços de medicamentos mais baixo. - Os medicamentos sujeitos a receita médica que não tenham sido objeto de avaliação prévia para efeitos de aquisição pelos hospitais do SNS, nem de decisão de comparticipação, ficam sujeitos a revisão anual: - se não existir outro medicamento autorizado ou comercializado, ou existir apenas medicamento original de marca e licenças, com a mesma substância ativa, dosagem e forma farmacêutica; - ou o medicamento tiver valores de consumo no ano anterior reportado pelos hospitais do SNS superior a milhão de euros. O preço de venda ao armazenista (PVA) revisto destes medicamentos não pode exceder o PVA mais baixo em vigor nos países de referência.
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Estatuto do Medicamento: nova alteração com republicação de todo o diploma (destaque de alterações mais relevantes)
O Decreto-Lei n.º 20/2013, de 14 de Fevereiro, procede à sétima alteração ao Decreto-Lei n.º 176/2006, de 30 de Agosto, que estabelece o regime jurídico dos medicamentos de uso humano, e transpõe a Diretiva n.º 2010/84/UE do Parlamento Europeu e do Conselho, de 15 de Dezembro de 2010. Breve Resumo das Principais Alterações Introduzidas ao Estatuto do Medicamento pelo Decreto-Lei n.º 20/2013 Enquanto a Agência não puder garantir as funcionalidades da base de dados Eudravigilance, os titulares da autorização de introdução no mercado devem:
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Intervenções Sistema Telefónico Phagecon
Estimado cliente,
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Revisão de Normas Orientadoras referentes às Boas Práticas de Fabrico (BPF) de Medicamentos
A Comissão Europeia divulgou no passado dia 17-01-2013, para consulta pública, versões revistas de alguns dos capítulos das normas orientadoras às BPF. Os capítulos em causa e respetivas alterações são:Capítulo 3: Instalações e Equipamento A única alteração ocorre na secção 6, como parte de uma norma orientadora melhorada, sobre a prevenção da contaminação cruzada (ver também Capítulo 5: Produção). É incluída a referência a uma nova norma orientadora sobre avaliação toxicológica complementar.Capítulo 5: Produção Foram feitas alterações nas secções 17 a 20 de forma a melhorar as orientações relativas à prevenção da contaminação cruzada e de forma a referir a norma orientadora sobre avaliação toxicológica. Foram também introduzidas alterações nas secções 26 a 28 (qualificação de fornecedores) refletindo a obrigação legal dos titulares de autorizações de fabrico de garantirem que as substâncias ativas são produzidas de acordo com as BPF. As alterações incluem rastreabilidade da cadeia de aprovisionamento. É adicionada uma secção adicional (33) para clarificar e harmonizar as expetativas dos fabricantes no que diz respeito à análise das matérias-primas. A secção (68) introduz diretrizes sobre a notificação de restrições no aprovisionamento.Os Capítulos 3 e 5 devem ser lidos em conjunto com a versão draft da norma orientadora da EMA sobre o estabelecimento de limites de exposição, com base na saúde, a utilizar na identificação do risco no fabrico de diferentes medicamentos em instalações partilhadas Capítulo 6: Controlo de Qualidade Inclusão de uma nova secção referente a Transferência Técnica de Métodos de Análise e outros itens tais como resultados fora de especificação.Capítulo 8: Reclamações, Defeitos de Qualidade e Retirada de Produtos do Mercado Refletir a aplicação dos princípios de Gestão de Risco na investigação de defeitos/reclamações e quando se tomam decisões em relação à retirada de produtos do mercado ou outras ações de diminuição do risco. Destacar a necessidade de investigar e determinar a(s) causa(s) dos defeitos/reclamações e que sejam implementadas as ações preventivas apropriadas para prevenir a recorrência da situação. Clarificar expectativas e responsabilidades no que diz respeito à notificação de defeitos de qualidade às autoridades competentes.Para consultar as normas orientadoras revistas para consulta publica cole o link http://ec.europa.eu/health/human-use/quality/developements/index_en.htm no seu browser. Comunicaremos qualquer aspeto relevante em relação a este processo e colocamo-nos à disposição para qualquer esclarecimento adicional. Read more
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Phagecon Conclusão de projeto de investimentoA Phagecon informa que concluiu em 2011 um investimento amplo, cofinanciado por verbas do QREN, que totalizou 165.156 euros e proporcionou a dotação de meios tecnológicos avançados, meios humanos qualificados e desenvolvimentos frutíferos em mercados internacionais. A Phagecon adquiriu maior dimensão e melhorou a sua capacidade de serviço, fatores importantes para maximizar a satisfação dos seus clientes. Read more
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The EMA has published the Reporting requirements of ICSRs applicable to MAH during the interim period (September 2012)
Phagecon informs that it was published by the European Medicines Agency the Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim period. During the interim period, in accordance with the transitional provisions set out in Article 2(4) and Article 2(5) of Directive 2010/84/EU, the reporting requirements detailed in tabular format in the link above (Table 1) shall apply to valid ICSRs reported by healthcare professionals and non-healthcare professionals. This is independent of the conditions of use of the suspected medicinal products and of the expectedness of the adverse reactions. Member States may request marketing authorisation holders to report electronically to EudraVigilance serious EU ICSRs originating in their territory. Those requirements are detailed in tabular format in the link above (Table 2). Member States reporting requirements during the interim period for serious non-EU ICSRs and for non-serious EU ICSRs are also presented in tabular format in the link above (Table 3). Phagecon provides support concerning all aspects of ICSRs management and other Pharmacovigilance obligations in the European Union. Contact us for more information.
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European Medicines Agency publishes list of EU reference dates and frequency of PSUR submission
Phagecon informs that it was published by the European Medicines Agency the list of European Union reference dates and frequency of submission of periodic safety update reports (PSUR) known as the 'EURD list'. The EURD list is a comprehensive list of active substances and combinations of active substances contained in medicinal products subject to different marketing authorisations, together with the corresponding Union reference dates, frequencies for submission of PSURs and related data lock points. The Union reference date corresponds to the date of the first marketing authorisation in the Union of a medicine containing that active substance or that combination of active substances, or alternatively the earliest of the known dates of the marketing authorisations for a medicine containing that active substance or that combination of active substances. The PSUR frequency and related data lock points for a given active substance or combination of active substances in the EURD list take effect six months after the publication date and overrule the submission schedule described in Article 107c (2) of Directive 2010/84/EU, and any conditions related to the frequency of submission of PSUR included in the marketing authorisation. Marketing authorisation holders are required to submit PSURs to the National Competent Authorities or the Agency according to the dates published in the EURD list. Marketing authorisation holders and other stakeholders can request amendments to the EURD list for the following reasons: Any changes to the list, following a request for amendment, are approved by the Committee for Medicinal Products for Human Use (CHMP) and the Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) following consultation with the Pharmacovigilance and Risk Assessment Committee (PRAC). Changes take effect six months after the publication date of the amended list for the products containing the concerned active substance or combination of active substances. The EURD list aims to support and optimise the management of PSUR submission and PSUR (single) assessment within the European Economic Area. Phagecon provides support concerning all aspects of PSUR submissions and other Pharmacovigilance obligations in the European Union. Contact us for more information.
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Procedimento de Licenciamento das Unidades Privadas de Saúde
A Phagecon informa que foi publicada em Diário da República a Portaria n.º 290/2012, de 24 de Setembro, que no âmbito do Decreto-Lei n.º 279/2009, de 6 de Outubro, estabelece os requisitos técnicos a que deve obedecer o exercício da atividade das unidades privadas que prossigam atividades no âmbito da prestação de serviços de saúde e que disponham de internamento.
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Infarmed Inicia Operação de Fiscalização sobre Dificuldades de Acesso ao Medicamento
A Phagecon informa que o INFARMED no âmbito das suas competências enquanto entidade reguladora do medicamento e com o objetivo de controlar todas as situações que impeçam o regular abastecimento de qualquer medicamento no mercado nacional e o acesso dos utentes aos medicamentos de que necessitam, irá desencadear as seguintes ações:
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Extensão ao Procedimento Nacional do Regulamento das Alterações
A circular nº 190 do Infarmed informa que foi publicado, a 4 de agosto, o Regulamento (UE) n.º 712/2012 da Comissão, de 3 de agosto de 2012, que altera o Regulamento das Alterações (Regulamento (CE) n.º 1234/2008 da Comissão, de 24 de novembro de 2008). Este diploma estabelece as seguintes modificações: O Regulamento (UE) n.º 712/2012 é aplicável a partir de 2 de novembro de 2012, com exceção do artigo 1º - n.º 10, 15, 18, alíneas a) e c), 21, 22 e 23, os quais apenas são aplicáveis a partir de 4 de agosto de 2013. Assim, as alterações aos termos da AIM submetidas por procedimento nacional continuarão a estar sujeitas às regras nacionais de cada Estado Membro (em Portugal continua a aplicar-se o disposto no Decreto-Lei n.º 176/2006, de 30 de agosto). A extensão ao procedimento nacional do regulamento de alterações, tal como descrita no novo capítulo II-A do regulamento revisto, apenas será aplicável a partir de 4 de agosto de 2013. A Phagecon presta apoio aos seus clientes nesta e noutras temáticas regulamentares, encontrando-se ao seu inteiro dispor para qualquer esclarecimento necessário. Contacte-nos!
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Novas regras de importação de substâncias ativas farmacêuticas para a União Europeia
No passado dia 25 de julho, a Comissão Europeia publicou um folheto informativo relativo às novas regras de importação de substâncias ativas para o fabrico de medicamentos de uso humano na europa. A partir de 2 de janeiro de 2013, todas as substâncias ativas importadas devem ser fabricadas em conformidade com os padrões definidos para as boas práticas de fabrico (BPF) europeias, que são os da ICH Q7. Igualmente a partir desta data, esta conformidade deverá ser confirmada por escrito pela autoridade competente do país exportador sendo que neste documento deverá também ser atestado que a unidade de fabrico está sujeita ao controlo e à execução das BPF europeias. O template relativo a este documento encontra-se no Folheto agora publicado. A Phagecon encontra-se à disposição dos seus clientes para o esclarecimento de qualquer questão adicional. Read more
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Alteração do Regime Jurídico e do horário de funcionamento das Farmácias de Oficina
No passado dia 1 de agosto, foram publicados dois diplomas legais, Decreto-Lei n.º 171/2012 e Decreto-Lei n.º 172/2012 que alteram respetivamente o regime jurídico das farmácias de oficina (DL n.º 307/2007, de 31 de Agosto) e o seu horário de funcionamento (DL n.º 53/2007, de 8 de Março). De acordo com a referida legislação que entrou ontem em vigor, as farmácias que violem o dever de providenciar, com a brevidade possível, pela obtenção dos medicamentos solicitados que se encontrem esgotados passam a estar sujeitas a uma multa que poderá ir até 20 mil euros. O novo regime jurídico das farmácias vem reforçar algumas das contraordenações a que estas se encontram sujeitas. O primeiro diploma prevê ainda que as farmácias, caso não consigam os medicamentos nos fornecedores, possam pedi-los a outras farmácias. Passa a estar prevista uma contraordenação para os casos em que as farmácias não respeitam a prescrição médica, de acordo com a legislação em vigor. O segundo diploma introduz um regime excecional de funcionamento para as farmácias em que o valor de faturação ao SNS seja igual ou inferior a 60% da média a nível nacional. Estas farmácias só estarão obrigadas a ter um farmacêutico e não os dois obrigatórios por lei e poderão ter áreas e horários reduzidos. Esta exceção está dependente de comunicação por parte do INFARMED, I.P.. A Phagecon encontra-se à disposição dos seus clientes para o esclarecimento de qualquer questão adicional. Read more
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DGS - Atualização da área referente a Biocidas
A Direção-Geral de Saúde procedeu a nova atualização dos conteúdos "Saúde de A a Z - Biocidas" do seu sítio Web, datada de 16 de julho de 2012. Salienta-se a publicação do Regulamento (UE) n.º 528/2012, de 22 de maio, relativo à disponibilização no mercado e à utilização de produtos biocidas, que substitui integralmente a Diretiva 98/8/CE, e que é aplicável a partir de 1 de setembro de 2013. A lista de diplomas de inclusão de substâncias ativas biocidas nos anexos I do Decreto-Lei n.º 121/2002 também foi atualizada dada a publicação recente de diretivas de inclusão. A Direção-Geral de Saúde prossegue com a atualização das listas de autorizações de venda emitidas de acordo com o período transitório (disponibilizadas no ponto 2.1.1 do texto "Saúde de A a Z - Biocidas"), bem como a da lista de autorizações por reconhecimento mútuo (disponibilizadas no ponto 4.2 do texto "Saúde de A a Z - Biocidas"). Foi ainda disponibilizada informação sobre os prazos de notificação das empresas do setor, relativos a determinados tipos de produtos biocidas, na sequência da publicação de diretiva de inclusão de substâncias ativas que esses produtos possam conter. A Phagecon disponibiliza apoio aos seus clientes em todas as atividades supramencionadas. Consulte-nos para o esclarecimento de qualquer questão adicional. Read more
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Update on the EMAs Q&A on practical transitional measures for the implementation of the pharmacovigilance legislation
EMA has released an updated Question and Answer (Q&A) document on the practical considerations concerning the initial phases of operation of the new pharmacovigilance legislation (Regulation (EU) No 1235/2010 and Directive 2010/84/EU). The Q&A applies to all medicinal products for human use regardless of the route of authorisation. Any specificities depending on the route of authorisation (i.e. centralized procedure versus mutual recognition/decentralised procedure and purely national procedure) are highlighted when appropriate. The Q&A document should be read in conjunction with Commission Questions and Answers on transitional arrangements. The questions and answers in this document represent the view of the EMA and Member States and have been subject to consultation with the European Commission. In case of doubt reference is given to the above-mentioned Union Directive and Regulation as well as to the Commission Implementing Regulation (EU) No 520/2012. This document provides a series of questions and answers to clarify procedural elements in relation to the implementation of the new legislation. The questions are organised into the following themes: The Regulation and Directive as referred to above enter into force respectively on 2 July and 21 July 2012. Therefore when referring to dates of application for both centrally authorised products (CAPs) and nationally authorised products (NAPs) including products authorised through the mutual recognition and decentralised procedures (MRP/DCP), the Q&A states 2 / 21 July 2012. This document is intended to be updated with additional clarifications as the implementation of the new pharmacovigilance legislation progresses. For queries in relation to a specific centrally authorised product, applicants/MAHs are advised to raise these with their Product Team Leader, especially for regulatory procedures which will start before July 2012 and will continue after July 2012 and may be affected by the new legislation. For queries in relation to a specific medicinal product authorised through the MRP/DCP, applicants/MAHs are advised to liaise with the Reference Member State. For purely nationally authorised medicinal products, the applicants/MAHs are advised to contact the relevant national competent authority. Please find the complete Q&A document on the link available above.
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Aprovação do preço dos medicamentos sujeitos a receita médica e não sujeitos a receita médica
Com a publicação do Decreto-Lei n.º 152/2012, de 12 de julho, o Infarmed passa, a partir de 1 de agosto de 2012, a ser a entidade competente para autorizar o Preço de Venda ao Público (PVP) dos medicamentos sujeitos a receita médica e dos medicamentos não sujeitos a receita médica comparticipados. Esta competência encontrava-se anteriormente atribuída à Direção Geral das Atividades Económicas (DGAE), a qual continuará a ser ouvida sobre esta matéria, para emissão de parecer não vinculativo, conforme previsto no n.º 1 do artigo 4.º do Decreto-Lei n.º 112/2011, de 29 de novembro, com a redação dada pelo Decreto-Lei n.º 152/2012, de 12 de julho. Pedido de aprovação de preço Pedido de revisões excecionais de preço (REP) Notificação de alterações temporárias de preço Declarações de preço Informações adicionais
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Portal RAM Infarmed possibilita notificação online de suspeitas de reações adversas a medicamentos por profissionais de saúde e utentes
O Infarmed desenvolveu uma aplicação - Portal RAM - que permite facilitar e tornar mais célere a notificação das suspeitas de reação adversa a medicamentos (RAM) por parte dos profissionais de saúde e, simultaneamente, envolver os utentes no Sistema Nacional de Farmacovigilância. O Portal RAM surge no contexto da nova legislação europeia de farmacovigilância (Diretiva 2010/84/EU, de 15/12/2010), que introduziu alterações significativas nos sistemas nacionais de farmacovigilância, nomeadamente a possibilidade de notificação online de suspeitas de RAM pelos profissionais de saúde e, pela primeira vez, permitindo também aos utentes notificar suspeitas de RAM. Embora se pretenda convergir todas as notificações para o Portal RAM, manter-se-á disponível a notificação em papel, através dos formulários já existentes para os profissionais de saúde, criando-se também um novo formulário destinado aos utentes (disponibilizado em www.infarmed.pt). O Portal RAM está disponível a partir de hoje, dia 23 de julho de 2012, e pode ser acedido através do sítio do Infarmed na Internet (www.infarmed.pt) ou diretamente em http://extranet.infarmed.pt/page.seram.frontoffice.seramhomepage. A farmacovigilância contribui para um melhor conhecimento do perfil de segurança dos medicamentos, para uma utilização mais racional dos mesmos e, consequentemente, para a defesa da saúde pública. A notificação de qualquer suspeita de reação adversa é um contributo essencial para a monitorização contínua da segurança dos medicamentos, sendo necessária a colaboração de todos os utentes e profissionais de saúde. Read more
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Relatório de Junho do infarmed revela que encargos dos utentes com medicamentos diminuíram 5,7%.
A última Análise do Mercado de Medicamentos em ambulatório do INFARMED Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. (Infarmed) referente a junho, demonstra que os encargos dos utentes com medicamentos diminuíram 5,7% face ao período homólogo (mercado SNS) e que o preço médio dos Medicamentos Genéricos atingiu o valor mínimo dos últimos 5 anos, situando-se agora nos 6,72. Estes valores confirmam a tendência de descida geral no preço dos medicamentos cujo mercado total diminuiu 11,8% em valor entre janeiro e junho de 2012 (1 317,9 milhões de euros) comparativamente a igual período de 2011 (1 494,7 milhões de euros), tendo-se registado, no mesmo período um aumento em embalagens de 2,0% (traduzindo um acréscimo de aproximadamente 2,3 milhões de embalagens). No mercado do SNS, os encargos com medicamentos, no período de janeiro a junho de 2012, foram 612,5 milhões de euros que reflete uma diminuição de 7,2% face ao período homólogo de 2011. Neste mercado, entre janeiro e maio de 2012, o valor a PVP registou uma descida de 5,5% face ao homólogo de 2011, o que contribuiu para a redução dos encargos do SNS com medicamentos (-5,4%) e a redução também dos encargos dos utentes (- 5,7%). No mercado de medicamentos genéricos, o preço médio global tem vindo a descer de forma sustentada desde 2º semestre de 2010. Em junho de 2012, foi atingido o valor mínimo dos últimos 5 anos (6,72) registando um decréscimo de 66,9% comparativamente a igual mês de 2007 (20,32). Em média, um medicamento genérico custa em junho de 2012 menos 4,03 do que em junho de 2011. Este comportamento do mercado traduz-se num crescimento da quota de mercado em volume, de 21,2% no primeiro semestre de 2011 para 24,5% no mesmo período de 2012, e redução da quota de mercado em valor, de 18,8% entre janeiro e junho de 2011 para 17% entre janeiro e junho de 2012. A quota de mercado em volume que atingiu pela primeira vez no anterior mês de maio um valor superior a 25%, mantendo-se nos 25,2% em junho de 2012. Read more
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Ministério da Saúde altera a lista de substâncias ativas que podem ser incluídas em produtos biocidas
Este decreto-lei visa transpor para a ordem jurídica interna oito diretivas europeias que alteram o anexo I da Diretiva n.º 98/8/CE, do Parlamento Europeu e do Conselho, de 16 de fevereiro, relativa à colocação no mercado dos produtos biocidas (inseticidas, acaricidas, herbicidas, etc.). Os designados produtos biocidas compreendem uma vasta gama de substâncias ativas e de preparados que as contêm, de composição muito variada, e cobrem um amplo leque de utilizações, constituindo uma arma muito eficaz no combate aos organismos nocivos e atuando ao nível dos produtos e dos processos com nítido benefício para a proteção da saúde humana e animal, e para a salvaguarda do ambiente, desde que observadas determinadas condições. A harmonização legislativa gerada pela referida Diretiva n.º 98/8/CE tem em vista propiciar uma utilização segura para a saúde humana e animal, e para o ambiente, dos produtos biocidas necessários para o controlo dos organismos nocivos para o homem ou para a saúde animal e dos que provocam danos nos produtos naturais ou transformados. O citado anexo I constitui a lista de substâncias ativas biocidas cujos requisitos de inclusão em produtos biocidas foram decididos a nível europeu. A aprovação dessas substâncias depende de decisão da Comissão Europeia, no sentido de incluí-las num dos anexos I, I-A ou I-B da referida diretiva, precedida de avaliação por um Estado membro. O presente decreto-lei procede, assim, à transposição para o direito nacional das Diretivas n.os 2011/66/UE, 2011/67/UE, 2011/69/UE, da Comissão, de 1 de julho, da Diretiva n.º 2011/71/UE, da Comissão, de 26 de julho, e das Diretivas n.os 2011/78/UE, 2011/79/UE, 2011/80/UE, 2011/81/UE, da Comissão, de 20 de setembro, que determinaram a inclusão das substâncias ativas 4,5 -dicloro-2-octi l-2H -isotiazol-3-ona, abamectina, imidaclopride, creosote, Bacillus thuringiensis subsp. israelensis, serótipo H14, estirpe AM65 -52, fipronil, lambda -cialotrina, deltametrina no anexo I da Diretiva n.º 98/8/CE, de 16 de fevereiro, para os usos especificados. Para consultar o decreto-lei Decreto-Lei n.º 154/2012, de 16 de Junho por favor clique no link acima disponibilizado.
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Ministério da Saúde procede à primeira alteração ao DL n.º 112/2011 que aprova o regime da formação do preço dos MSRM e dos MNSRM comparticipad
O Memorando de Entendimento firmado com a Troika determina a implementação de medidas específicas em relação ao regime de fixação de preços de medicamentos.
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European Medicines Agency finalises first set of guidelines on good pharmacovigilance practices
The European Medicines Agency has published the first set of finalised modules of the guideline on good pharmacovigilance practices (GVP) on the 25th of June 2012. The finalisation of these seven modules is a key deliverable of the 2010 pharmacovigilance legislation, which will apply from Monday 2 July 2012. Each of the modules covers one major process in the safety monitoring of medicines. These are: GVP is a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). They apply to marketing-authorisation holders, the Agency and medicines regulatory authorities in EU Member States and aim to improve safety for patients by strengthening the monitoring of the safety of medicines across the EU. They cover medicines authorised centrally via the Agency as well as medicines authorised at national level. Each module was developed by a team consisting of experts from the Agency and from EU Member States, and was released for public consultation between February and April 2012. The final versions of the modules have been updated, taking the comments received during the public consultation into account. The comments received have also been published today. The remaining seven draft modules making up the entire GVP package are under development and will be released for consultation later in the year. The GVP modules are aligned with the European Commission's implementing regulation , published last week. This regulation is a legally binding act that provides details on the operational aspects for the new legislation. The finalised GVP modules on post-authorisation safety studies and risk management plans refer to the guide on methodological standards in pharmacoepidemiology , which is available on the website of the European Network of Centres in Pharmacoepidemiology and Pharmacovigilance (ENCePP). This guide, which was revised last week after an extensive consultation period and expert review, includes methodological guidance for experienced and new researchers in pharmacoepidemiology and pharmacovigilance. For each topic covered, direct electronic access is given to internationally agreed recommendations and key points from important guidelines, published articles and textbooks after an introductory review. On the 25th of July was also published an updated version of the European Medicines Agency and Member States joint implementation checklist, which provides an overview of the prioritisation of tasks linked to the implementation of the legislation.
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EMA has Updated XEVMPD Frequently Asked Questions document
Phagecon informs that a new version of the eXtended EudraVigilance Medicinal Product Report Message (XEVPRM) Frequently Asked Questions & Answers (FAQs) has been published by the European Medicines Agency (EMA) and it is now available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000336.jsp&mid=WC0b01ac05804d8b2b
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Síndrome de Steven-Jonhson (SSJ) e Necrólise Epidérmica Tóxica (NET)
Na sequência da avaliação realizada pelo Grupo Europeu de Farmacovigilância (PhVWP), o INFARMED Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. informa que deve ser implementada uma atualização da informação de segurança de todos os medicamentos de uso sistémico que contenham uma das 14 substâncias ativas que apresentam um risco potencial elevado para a ocorrência de síndrome de Stevens-Jonhson (SSJ) e de necrólise epidérmica tóxica (NET). Apesar de serem muito raras, a SSJ e a NET são reações adversas cutâneas graves e potencialmente fatais. O grupo do projeto RegiSCAR (Registry of Severe Cutaneous Adverse Reactions) informou a Agência Europeia do Medicamento (EMA) dos resultados da análise efetuada às referências a reações adversas cutâneas graves constantes do Resumo das Características do Medicamento (RCM) e Folheto Informativo (FI) de vários medicamentos e à evidência que as fundamentam. Como não é possível atuar sobre a etiologia destas reações adversas, o diagnóstico precoce tem um papel primordial como medida de minimização do risco: se os doentes e os profissionais de saúde forem devidamente informados e alertados para os sinais e sintomas destas reações cutâneas, as medidas adequadas podem ser iniciadas mais cedo. O PhVWP acordou os elementos-chave que devem existir no RCM e no FI dos medicamentos com estas substâncias ativas. O objetivo é garantir que todos contêm informação clara e igual sobre estas reações adversas graves. Neste caso em particular, como acordado entre todos os Estados Membros, os Titulares de AIM destes medicamentos não serão notificados para a submissão de uma alteração de segurança específica. No entanto, esta informação de segurança deve ser implementada no âmbito do próximo procedimento regulamentar (exemplos: alteração aos termos da AIM ou renovação dos termos da AIM) em que sejam atualizados o RCM e o FI dos medicamentos em causa, tendo em consideração o seguinte: - Os elementos-chave sobre SSJ e NET devem servir de base à informação a incluir no RCM e FI; pode ser incluída informação adicional específica para cada substância ativa, dependendo da evidência disponível; - A informação deve ser clara e colocada com destaque na secção 4.4 do RCM e na secção 2 do FI (não deve ser colocada no fim das secções); - A informação sobre SSJ e NET deve ser adaptada a cada medicamento e a sua preponderância equilibrada face à informação já existente relativa a outras reações adversas graves.
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Spanish Medicines Agency updates national electronic submission guidance
The Spanish Medicines Agency "Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)" has released an updated version 2.2 of their national electronic submission guidance "ENVÍO POR PARTE DE LOS LABORATORIOS DE INFORMACIÓN EN FORMATO ELECTRÓNICO A LA AEMPS".
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Governo Atribui ao Infarmed Responsabilidade pela Fixação dos Preços dos Medicamentos
O Governo aprovou na passada Quinta-feira, dia 24 de Maio de 2012, em Conselho de Ministros, um diploma que atribui ao Infarmed a responsabilidade pela fixação dos preços de venda ao público dos medicamentos sujeitos a receita médica e dos não sujeitos a receita médica e comparticipados.
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EMA has published practical guidance on implementation of the new pharmacovigilance legislation
The document, published today, clarifies some practical considerations that pharmaceutical companies will need to take into account before and after the legislation starts to apply in July this year. It includes the agreed position of the European Union (EU) regulatory network, following discussions between the Agency, national regulatory authorities and the European Commission services. The document includes answers to frequently asked questions on the following topics: The Agency will update the question-and-answer document on a regular basis with questions received at qanda-pv-legislation@ema.europa.eu. The Agency cannot reply directly to questions submitted to this address.
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Alterações ao sistema de notificação de ruturas de stock
Foi publicada a Deliberação n.º 050/CD/2012, de 12/04/2012, com o objetivo de melhorar a informação prestada a todos intervenientes do setor, e em especial aos profissionais de saúde, sobre as situações de rutura de stock. Esta Deliberação entrou em vigor no dia 22/05/2012 (data de publicação da Circular Informativa N.º 112/CD) e aplica-se a todos os medicamentos (sujeitos e não sujeitos a receita médica) e complementa a atual forma de notificação das ruturas de stock ou de cessação da comercialização. Para dar cumprimento à Deliberação, os titulares de autorização de introdução no mercado (AIM) têm que: Todas as situações de suspensão, cessação da comercialização, ruturas de stock transitórias e pedidos de revogação de AIM têm que ser classificadas pelos titulares de AIM, quanto ao seu impacto, em 3 níveis: 1. Reduzido Existem medicamentos iguais (mesma substância ativa, forma farmacêutica e dosagem) ao medicamento em causa; Nas situações classificadas como tendo umimpacto médio e elevado, o titular de AIM tem que enviar, por e-mail para ruptura.medicamentos@infarmed.pt, os seguintes dados: - Identificação do(s) substituto(s) terapêutico(s) e medidas necessárias para a sua substituição; Adicionalmente, para todas as situações classificadas como tendo um impacto elevado, os titulares têm ainda que enviar um plano de contingência para minimizar o impacto da ausência do fornecimento do medicamento. O Infarmed encontra-se a desenvolver uma nova ferramenta de notificação de ruturas de stock que permitirá a notificação de todos os medicamentos (incluindo os medicamentos não sujeitos a receita médica), do risco associado à rutura e inclusão dos elementos acima mencionados. Até que esta aplicação esteja disponível, as notificações devem continuar a ser efetuadas como até aqui, através da aplicação Rupturas de fornecimento de medicamentos (http://app.infarmed.pt/sgrt/listrstock.aspx). Os elementos constantes na Deliberação devem ser enviados para o e-mail ruptura.medicamentos@infarmed.pt.
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Comparticipação de medicamentos
Apresentações essenciais para a submissão de pedidos de comparticipação (maio de 2012)
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New e-learning course
The European Medicines Agency has launched an e-learning course for marketing authorisation holders to support compliance with Article 57(2) on the submission of information on medicines, one of the key measures of the new pharmacovigilance legislation.
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Despacho nº 6716/2012Foi publicado o Despacho nº 6716/2012, do Ministério da Saúde, que estabelece regras específicas para a dispensa das terapêuticas com antirretrovíricos às pessoas que vivem com VIH/SIDA e adequada utilização do sistema SI.VIDA. Read more
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Produtos Cosméticos e de Higiene CorporalFoi publicada em Diário da República a Declaração de Retificação nº 24-A/2012, que vem corrigir algumas inexatidões presentes no DL nº 63/2012, de 15 de março, nomeadamente no seu anexo, nas referências ao termo zircónio e nas entradas nºs 208, 209 e 249. Read more
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Prescrição por DCI
Foi publicada a Portaria nº 137-A/2012, de 11 de maio, do Ministério da Saúde, que regulamenta a Lei nº 11/2012, de 8 de março, estabelecendo o regime jurídico a que obedecem as regras de prescrição de medicamentos, os modelos de receita médica e as condições de dispensa de medicamentos, bem como definindo as obrigações de informação a prestar aos utentes.
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Article 57 (2) requirements
European Medicines Agency publishes new versions of controlled vocabularies used to comply with Article 57 (2) requirements on submission of information on medicines.
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European Medicines Agency
The Committee on Herbal Medicinal Products (HMPC) at the European Medicines Agency has approved its 100th herbal community monograph since the Committee began work in 2004. This is a significant achievement for the Committee and a key step in in supporting the harmonisation of procedures and provisions for herbal medicinal products within the European regulatory framework.
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ICH E2C (R2) guideline
Comments invited on the ICH E2C (R2) guideline on periodic benefit-risk evaluation report
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Delegados de Informação Médica
Com vista a simplificar o processo de comunicação e registo dos Delegados de Informação Médica (DIM), o Infarmed disponibiliza uma nova versão de aplicação online no seu site.
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EURD list public consultation
Feedback requested on the draft list of EU reference dates for periodic safety update reports in preparation for introduction of the new pharmacovigilance legislation.
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Dispositivos médicos
Foi publicado o Regulamento (UE) Nº 207/2012 da Comissão, de 9 de março que estabelece as condições em que as instruções de utilização dos dispositivos médicos podem ser fornecidas em formato eletrónico (e-IDU), em alternativa ao formato em papel.
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Dossiê de AIM
A guideline europeia HMA/EMA Guidance document on the identification of commercially confidential information and personal data within the structure of the Marketing Authorisation (MA) dossier - release of information after granting of a marketing authorisation, de que o Infarmed foi relator, foi aprovada no dia 9 de março pelos Chefes das Agências de Medicamentos da União Europeia e pela Agência Europeia de Medicamentos (EMA).
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Boas práticas CMDh
CMDh BEST PRACTICE GUIDES FOR THE SUBMISSION AND PROCESSING OF VARIATIONS IN THE MUTUAL RECOGNITION PROCEDURE - Rev 16.
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Consulta pública
A nova legislação europeia de farmacovigilância (Diretiva 2010/84/UE do Parlamento Europeu e do Conselho de 15 de dezembro de 2010 e Regulamento (UE) n.º 1235/2010 do Parlamento Europeu e do Conselho de 15 de dezembro de 2010) foi publicada em dezembro de 2010.
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Despacho nº 4343/2012Foi publicado o Despacho nº 4343/2012, pelos Ministérios da Economia e do Emprego e da Saúde - Gabinetes dos Secretários de Estado do Empreendedorismo, Competitividade e Inovação e da Saúde, que aprova os preços de referência unitários dos grupos homogéneos, para vigorar no trimestre civil que se inicia em 1 de abril de 2012. Read more
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Biocidas
Foi publicado o DL nº 72/2012, de 23 de Março, que transpõe para a ordem jurídica nacional as Diretivas n.os 2011/10/UE, 2011/11/UE, 2011/12/UE e 2011/13/UE, da Comissão, de 8 de fevereiro, com alteração da lista de substâncias ativas que podem ser incluídas em produtos biocidas, tendo em vista a proteção da saúde humana e animal, bem como a salvaguarda do ambiente.
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Contratos Públicos de AprovisionamentoFoi publicado o Despacho n.º 4225/2012 do Ministério da Saúde - Gabinete do Secretário de Estado da Saúde que revoga a obrigatoriedade de aquisição através dos Contratos Públicos de Aprovisionamento celebrados no âmbito do Concurso Público n.º 2010/3, para fornecimento de Corretivos da Volémia e outras Soluções Estéreis e no âmbito do Concurso Público n.º 2010/18, para fornecimento de Medicamentos do Consumo Geral e Outros. Read more
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Reconhecimento da avaliação
Os requerentes/titulares de Autorização de Introdução no Mercado (AIM) podem, mediante condições, requerer ao Infarmed que determinado medicamento beneficie da avaliação efetuada ou a efetuar para outro medicamento.
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Prescrição e dispensa de medicamentos
Foram publicados em Diário da República os seguintes novos diplomas legais:
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Legislação dos cosméticos
O Decreto-Lei n.º 63/2012, de 15 de março, procede à terceira alteração ao Decreto-Lei n.º 189/2008, de 24 de setembro, que estabelece o regime jurídico dos produtos cosméticos e de higiene corporal, alterado pelos Decretos-Leis n.os 115/2009, de 18 de maio, e 113/2010, de 21 de outubro, transpondo para a ordem jurídica nacional a Diretiva n.º 2011/59/UE, da Comissão, de 13 de maio, que altera a Diretiva n.º 76/768/CEE, do Conselho, de 27 de julho, relativa aos produtos cosméticos, a fim de adaptar os seus anexos II e III aos progressos técnicos.
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Formulário eletrónico fase piloto
A Agência Europeia do Medicamento (EMA) lançou em fase piloto uma ferramenta eletrónica para ser utilizada em pedidos de AIM centralizados.
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Prescrição e dispensa de medicamentos
A Lei nº 11/2012 hoje publicada vem estabelecer as novas regras de prescrição e dispensa de medicamentos, procedendo à sexta alteração ao regime jurídico dos medicamentos de uso humano, aprovado pelo DecretoLei n.º 176/2006, de 30 de agosto, e à segunda alteração à Lei n.º 14/2000, de 8 de agosto.
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Core Safety Profile (CSP)
A Direção de Gestão do Risco de Medicamentos (DGRM) informa todos os titulares de AIM que o Infarmed passará a disponibilizar nova informação acerca do Core Safety Profile (CSP) que irá estar disponível em Página Inicial > Medicamentos Uso Humano > Farmacovigilância > Informação de Segurança > Core Safety Profile (CSP).
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Farmacopeia Portuguesa
Declaração de retificação nº 352/2012 Ministério da Saúde/INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I. P.
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Preços
Foi hoje publicada pelo Infarmed I.P. a circular informativa nº 056/CD sobre a notificação eletrónica dos preços dos medicamentos.
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Electronic Submission of Information on Medicinal Products for Human Use
This legal notice has been prepared and updated by the European Medicines Agency (hereafter referred to as the Agency) to comply with the requirements for the electronic submission of information on medicinal products for human use authorised in the Union as provided for in Article 57(2), second sub-paragraph of Regulation (EC) No 726/2004.
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Requisitos obrigatórios para cumprimento do artigo 57(2)
A Agência Europeia do Medicamento (EMA) publicou um conjunto atualizado de requisitos obrigatórios para cumprimento pelos titulares de AIM do disposto artigo 57(2) da nova legislação da farmacovigilância. A informação obrigatória sobre os medicamentos de cada titular deverá ser submetida eletronicamente até 2 de Julho de 2012, podendo para tal as pequenas e médias empresas recorrer à ferramenta EVWEB disponibilizada pela EMA e que entrou hoje em fase de produção.
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Orgânica do INFAMED I.P.
Na sequência da aprovação da Lei Orgânica do Ministério da Saúde, com base em modelos de organização mais reduzidos e com menos custos, torna -se necessário proceder à revisão da estrutura orgânica dos organismos sob a tutela ou superintendência do Ministro da Saúde, como é o caso do INFARMED Autoridade Nacional do Medicamento e Produtos de Saúde, I. P.
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EudraVigilance
O Infarmed I.P. emitiu hoje uma nota informativa para todos os titulares de AIM na sequência do comunicado da EMA que refere que o ambiente de produção do EudraVigilance estará indisponível a partir das 17:30h de 29/02/2012 até às 09:00h de 05/03/2012.
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Good pharmacovigilance practices
The European Medicines Agency has released the first batch of modules on good pharmacovigilance practices (GVP) for public consultation until 18 April 2012.
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Pharmacovigilance legislation
The European Commission has published transitional arrangements for the new pharmacovigilance legislation in preparation for the coming into force of the legislation in July 2012. Of particular interest to marketing-authorisation applicants and holders, the document provides answers to both legal and practical questions on a range of topics including renewal of applications, pharmacovigilance system master files and risk management plans.
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Farmacovigilância
A nova legislação europeia de farmacovigilância (Directiva 2010/84/UE do Parlamento Europeu e do Conselho de 15 de Dezembro de 2010 e Regulamento (UE) N.º 1235/2010 do Parlamento Europeu e do Conselho de 15 de Dezembro de 2010) foi publicada em dezembro de 2010.
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Materiais educacionais e DHPC
Atualização das Instruções aos Requerentes Submissão de Materiais Educacionais e Comunicações Dirigidas aos Profissionais de Saúde
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Prescrição eletrónica de medicamentos
Foi publicada em Diário da República a Portaria nº 46/2012, de 13 de fevereiro, do Ministério da Saúde, que procede à primeira alteração à Portaria nº 198/2011, de 18 de maio, que estabelece o regime jurídico a que obedecem as regras de prescrição eletrónica de medicamentos.
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Acesso a medicamentos em ambiente hospitalar
Acesso a medicamentos fornecidos pelos serviços farmacêuticos dos hospitais do SNS, nomeadamente no âmbito dos regimes especiais de comparticipação
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Common European Submission Platform CESP
Plataforma Comum de Submissão Europeia CESP
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Avaliação prévia de medicamentos
Avaliação prévia de medicamentos sujeitos a receita médica para aquisição pelos hospitais do SNS
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MRP/DCP new applications
The Coordination Group for Mutual Recognition and Decentralized Procedures Human (CMDh) has released revision 3 of the cover letter template that should be used by applicants for initial applications submitted through MRP or DCP.
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Distribuição por grosso de medicamentos
O Infarmed I.P. emitiu hoje a Circular Informativa nº 020/CD, destinada às Associações grossistas de medicamentos e às empresas distribuidores por grosso, sobre o novo modelo de autorização para o exercício da atividade de distribuição por grosso de medicamentos de uso humano.
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Technical validation of marketing authorisation applications for medicines
From 3 January 2012, the MRHA will be performing a technical validation of all new MAA eCTD submissions.
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Farmácias nos Açores
Foi hoje publicado em Diário da República o Decreto Regulamentar Regional nº 3/2012/A da Região Autónoma dos Açores Presidência do Governo.
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Preço Afixado na Embalagem dos Medicamentos
Relativamente ao preço afixado nas embalagens dos medicamentos, o Infarmed vem esclarecer que:
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PIP breast implants
Scientific Committee on Emerging and Newly Identified Health Risks - Request for a rapid scientific opinion on the safety of PIP breast implants
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Medicamentos veterinários
Foi publicado em Diário da República o Despacho nº 403/2012, do Ministério da Agricultura, do Mar, do Ambiente e do Ordenamento do Território Direcção Geral de Veterinária, que fixa as normas e procedimentos a que obedece a alteração da classificação dos medicamentos veterinários quanto à dispensa.
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Uso off-label de medicamentos e dispositivos médicos
A Food and Drug Administration (FDA) publicou uma guidance sobre as informações prestadas pelas companhias farmacêuticas sobre o uso off-label de medicamentos e dispositivos médicos, nomeadamente em ambiente de redes sociais.
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Produtos cosméticos
Conforme divulgado na Circular Informativa n.º 098/CD de 01/06/2011 do Infarmed, a partir de 11 de janeiro de 2012, as pessoas responsáveis pela colocação de produtos cosméticos na União Europeia podem notificar os seus produtos no Portal de Notificação de Produtos Cosméticos (CPNP), que será disponibilizado pela Comissão Europeia.
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Implantes mamários
O INFARMED, I.P., enquanto responsável pelo Sistema Nacional de Vigilância de Dispositivos Médicos, vem relembrar da necessidade da notificação dos incidentes com dispositivos médicos, ocorridos em território nacional, de forma a adequar a gestão do risco e a garantir os melhores níveis de segurança na sua utilização.
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Medicamentos genéricos
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Sistema de Preços de Referência
O Infarmed publicou a lista de grupos homogéneos que entram em vigor no próximo trimestre, de acordo com o estabelecido no n.º 1 do artigo 27.º do regime geral das comparticipações do Estado no preço dos medicamentos aprovado pelo Decreto-Lei n.º 48-A/2010, de 13 de Maio, na sua redação atual, introduzida pelo Decreto-Lei n.º 106-A/2010, de 1 de Outubro.
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Publicidade a medicamentos
O Infarmed verificou que os Titulares de AIM, no preenchimento de notificações de peças publicitárias de medicamentos no Sistema de Gestão de Publicidade de Medicamentos (GPUB), continuam a não preencher e/ou não detalhar as informações relativas aos elementos de difusão da peça publicitária.
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Estado da comercialização dos medicamentos
A base de dados Infomed, inclui um novo campo relativo ao estado de comercialização dos medicamentos. Este estado de comercialização resulta da comunicação que é feita pelos titulares da AIM e é essencial para todas as entidades envolvidas no circuito do medicamento.
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Directiva medicamentos falsificados
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Novos preços dos medicamentos
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Genéricos e litígios sobre direitos de propriedade industrial
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Directiva Falsificados
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Código Deontológico e Código de Conduta
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Submissões electrónicas no Infarmed
A publicação da Deliberação nº 195/CD/2011 veio revogar a Deliberação 102/CD/2010, do Infarmed I.P.
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Farmacopeia Portuguesa
A Comissão da Farmacopeia Portuguesa é uma comissão técnica especializada do INFARMED Autoridade Nacional do Medicamento e Produtos de Saúde, à qual compete, genericamente, elaborar, rever, actualizar e interpretar a Farmacopeia Portuguesa, bem como emitir parecer, sempre que solicitada, sobre os assuntos com esta conexos.
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Associações de antiasmáticos e/ou broncodilatadores
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Decreto-Lei nº 112/2011
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Comercialização de medicamentos comparticipados
É da responsabilidade dos Titulares de AIM / representantes locais notificar ao Infarmed o início, suspensão ou cessação da comercialização dos seus medicamentos de uso humano.
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Prescrição Electrónica de Medicamentos
O Ministério da Saúde determina, no âmbito do regime da prescrição electrónica de medicamentos, para efeitos de comparticipação e monitorização da prescrição, que os dados relativos à identificação dos prescritores médicos, médicos dentistas e odontologistas, deverão ser objecto de actualização, nos termos do presente despacho, até ao dia 30 de Novembro de 2011.
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Revogação de Grupos Homogéneos
O Infarmed revoga os Grupos Homogéneos GH0770 e GH0771 (salbutamol, solução para inalação por nebulização, 2.5 mg/2.5 ml, [1-20] unidades e salbutamol, solução para inalação por nebulização, 5 mg/2.5 ml, [1-20] unidades, respectivamente), devido à inexistência no mercado de medicamentos genéricos contendo a substância activa Salbutamol, solução para inalação por nebulização.
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Publicidade a medicamentos
A presente circular constitui um aditamento à Circular Informativa nº 229/CD, publicada em 9/11/2011.
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Publicidade a medicamentos
No seguimento do Acórdão do Tribunal de Justiça de 5 de Maio de 2011, o Infarmed vem esclarecer que:
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Associações de antiasmáticos e/ou broncodilatadores
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Marcação de PVP nas embalagens de medicamentos
A APIFARMA divulgou através da sua E-News o seguinte esclarecimento:
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Fornecimento de antissépticos, desinfectantes, medicamentos de consumo geral e outros
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Call experts 2011
A Comissão Europeia está a convidar cientistas para se juntarem à estrutura de aconselhamento dos seus Comités Científicos e base de dados de peritos.
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Directiva 2010/84/UE - FarmacovigilânciaO jornal Oficial da União Europeia apresenta a Rectificação da Directiva 2010/84/UE do Parlamento Europeu e do Conselho, de 15 de Dezembro de 2010, que altera, no que diz respeito à farmacovigilância, a Directiva 2001/83/CE que estabelece um código comunitário relativo aos medicamentos para uso humano. Read more
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Genéricos com Sildenafil
O Infarmed foi notificado para divulgar junto dos distribuidores e farmácias a apreensão dos medicamentos genéricos Sildenafil Siltop e Sildenafil Farmoz, comprimido revestido por película, dosagens de 25 mg, 50 mg e 100 mg, importados, fabricados e armazenados pelas requeridas (Tecnimede - Sociedade Técnico-Medicinal, S.A. e a Farmoz - Sociedade Técnico Medicinal, S.A., respectivamente), assim como os que estejam disponíveis em farmácias.
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Comissão do programa do medicamento hospitalar
O Despacho n.º 13378/2011 estabelece a criação de uma comissão do programa do medicamento hospitalar, no seguimento da criação do programa do medicamento hospitalar, a qual tem como objectivos a actualização do referido programa, o reforço da intervenção das comissões de farmácia e terapêutica, a avaliação de situações que impeçam a uniformização da codificação hospitalar e dar a conhecer estas mesmas situações.
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Rectificação ao Despacho nº 13015/2011No seguimento de algumas incongruências, quer na numeração, quer no preço de referência unitário de alguns grupos homogéneos, do anexo I do despacho nº 13015/2011, publicado no Diário da República, 2ª série, nº 188, de 29 de Setembro, pode encontrar-se, no Diário de República, 2ª série, nº 194, de 10 de Outubro, o referido anexo rectificado. Read more
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Combate a medicamentos contrafeitos e ilegais
Em Setembro, 81 países e 165 agências estiveram envolvidas no combate à venda de medicamentos contrafeitos e ilegais e no alerta aos perigos associados à compra destes medicamentos.
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Extensão ao Procedimento Nacional do Regulamento das Alterações
O Regulamento das Alterações (Regulamento CE nº 1234/2008, de 24 de Novembro de 2008) tem como objectivo facilitar o processo de submissão e avaliação das alterações aos termos de Autorização de Introdução no Mercado (AIM), sem prejuízo do nível de protecção da saúde pública.
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Novo Regime de formação do preço dos medicamentosDecorrente da aprovação em Conselho de Ministros, do novo regime de formação do preço dos medicamentos que procede: à revisão do actual sistema de referenciação de preços, por alteração dos países de referência; estabelece um novo preço máximo de venda ao público do primeiro medicamento genérico a introduzir no mercado e altera as margens de comercialização dos medicamentos, a Phagecon disponibiliza através da ferramenta de pesquisa de preços, BUSCAMED, a previsão dos novos Preços de Venda ou Público (PVP) e a previsão dos novos Preços de Venda ao Armazenista (PVA), calculados com base nas novas margens de comercialização. Read more
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Procedimentos de Transmissão Electrónica com o InfarmedO Infarmed I.P. disponibiliza online o procedimento de testes de transmissão electrónica de casos de RAM (Individual Case Safety Reports ICSR) bem como a respectiva documentação de suporte, a adoptar pelos titulares de AIM / promotores de Ensaios Clínicos. É também possível consultar o procedimento a seguir caso haja uma falha no sistema que impeça a transmissão de ICSR ao Infarmed. Read more
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Novo Sistema de Farmacovigilância
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Proposta de extensão do Regulamento (CE) nº 1234/2008 às alterações aos termos da AIM submetidas por procedimento puramente nacional
As alterações aos termos da AIM submetidas por procedimento puramente nacional encontram-se excluídas do âmbito do Regulamento (CE) nº 1234/2008.
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Novas medidas sobre o Receituário Electrónico
O Memorando de Entendimento sobre as Condicionalidades de Política Económica (MoU) exige o cumprimento de um conjunto de medidas, nomeadamente na área da saúde, a implementar até ao final do ano de 2011.
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Pedidos de Autorização de Utilização Especial de Medicamentos pelos Hospitais do SNS
No seguimento dos pedidos de autorização especial de medicamentos pelos Hospitais do SNS, o Infarmed tem sido confrontado com situações de fornecimento gratuito de medicamentos por parte da Indústria Farmacêutica.
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Rotulagem dos dispositivos médicos novas disposições sobre o endereço do fabricante
O Central Management Committee (CMC) emitiu uma decisão, a 07 de Junho de 2011, sobre o teor da informação que deve estar contida no endereço do fabricante de dispositivos médicos, e do seu mandatário, quando aplicável, que deve constar na rotulagem e nas instruções de utilização.
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Criação da comissão científica para as boas práticas clínicas.
O Secretário de Estado Adjunto do Ministro da Saúde determinou a criação da comissão científica para as boas práticas clínicas, que ficará sob a tutela da DirecçãoGeral da Saúde.
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Listagem de dispositivos médicos para diagnóstico in vitro
O INFARMED, I.P., publicou no seu site, uma listagem de dispositivos médicos para diagnóstico in vitro de testes rápidos para a detecção de HIV 1/ 2.
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Revisão do Regime Especial de Comparticipação de Medicamentos
Foi publicada a Portaria nº 267-A/2011, de 15 de Setembro, que define as condições de inclusão de novos medicamentos no regime especial de comparticipação respectivo, quer se trate de medicamentos utilizados no tratamento de determinadas patologias ou por grupos especiais de utentes.
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Novos critérios de validação para submissão electrónica
A Agência Europeia do Medicamento (EMA) emitiu um comunicado a informar as empresas farmacêuticas, de que a partir de 1 de Setembro, entra em vigor uma nova versão dos critérios de validação para as aplicações electrónicas de medicamentos de uso humano.
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Medidas de Contenção de custos no Serviço Nacional de Saúde
Os Ministérios das Finanças e da Saúde fixam a meta de referência para a redução dos custos operacionais dos hospitais, centros hospitalares e unidades locais de saúde integrados no sector empresarial do Estado, para 2012, num valor inferior em 11 % ao de 2011, segundo o Despacho n.º 10783-A/2011 de 31 de Agosto de 2011.
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Documentos de Requisição de Meios Complementares de Diagnóstico e Terapêutica
O Ministério da Saúde Gabinete do Secretário de Estado da Saúde define o modelo das requisições electrónicas de meios complementares de diagnóstico e terapêutica e que o modelo de documento pré-impresso para efeitos de requisição manual passa a ser de utilização excepcional, segundo o Despacho n.º 10783-B/2011 de 31 de Agosto de 2011.
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Electronic submission of information on medicines
European Medicines Agency provides update on electronic submission of information on medicines
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Novas Medidas de Redução da despesa na Saúde
Ministro da Saúde Paulo Macedo apresentou ontem perante a Comissão Parlamentar de Saúde novas medidas de redução da despesa relacionada com os medicamentos.
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Proposta de lei sobre litígios de direitos de propriedade industrial de medicamentos
O Conselho de Ministros de 1 de Setembro aprovou uma proposta de lei que cria um regime de composição dos litígios emergentes de direitos de propriedade industrial quando estejam em causa medicamentos de referência e medicamentos genéricos.
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Governo facilita acesso aos medicamentos genéricos
O Conselho de Ministros de 1 de Setembro aprovou uma proposta de lei que vai facilitar o acesso dos medicamentos genéricos ao mercado, contribuindo para o aumento da respectiva quota de mercado e consequente redução da factura em medicamentos.
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Regulatory and procedural guideline: Member states contact points for translations review
Member states contact points for translations review
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Updated requirements from CMDh on electronic and paper submissions for MRP/DCP or National procedures
CMDh has released an updated version of the "Requirements on Electronic submissions (NeeS and eCTD) and paper documentation for New Applications within MRP, DCP or National procedures", document CMDh/085/2008/Rev8, version date July 2011.
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OMS publica nova Guideline para Armazenamento e Transporte de produtos farmacêuticos sensíveis ao tempo de transporte e temperatura.
Em Outubro de 2010 o WHO Expert Committee on Specifications for Pharmaceutical Preparations reuniu em Geneva, o relatório técnico resultante foi submetido ao WHO Executive Board e é agora publicado a Guideline para Armazenamento e Transporte de produtos farmacêuticos sensíveis ao tempo de transporte e temperatura (TTSPPs).
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Importação de medicamentos para uso pessoal
O INFARMED I.P. publicou a Circular Informativa nº 148/CD, de 29/07/2011, informando o público em geral sobre a legislação aplicável a propósito dos pedidos de importação de medicamentos para uso pessoal que assumem maior frequência em tempo de férias.
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Produtos para protecção solarO INFARMED I.P. publicou a Circular Informativa nº 134/CD, de 14/07/2011, informando o público em geral sobre a importância dos hábitos de protecção solar e alertando os operadores económicos para a necessidade de cumprirem com as disposições regulamentares relativas à rotulagem destes produtos e de apresentarem os seus produtos com toda a informação necessária para o consumidor, não negligenciando a importância da tradução de toda a informação obrigatória, em particular da categoria de eficácia de protecção solar que deve estar devidamente destacada na rotulagem. Read more
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Dificuldade de acesso a medicamentos nas farmácias
O INFARMED I.P. publicou a Circular Informativa nº 126/CD, de 07/07/2011, informando que tomou conhecimento das dificuldades no fornecimento de determinados medicamentos, por diversas farmácias, para os quais não foi reportada a sua ruptura de fornecimento do mercado pelo respectivo titular de AIM.
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Lei 46/2011 - Novos tribunais de competência especializada
Criação do tribunal de competência especializada para propriedade intelectual e do tribunal de competência especializada para a concorrência.
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Nimesulida - conclusão da revisão da relação benefício-risco
O INFARMED I.P. publicou a Circular Informativa nº 117/CD, de 24/06/2011, informando sobre a conclusão da revisão da relação benefício-risco dos medicamentos contendo nimesulida, cuja utilização fica restrita ao tratamento da dor aguda ou da dismenorreia primária.
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Indicação do PVP na rotulagem dos medicamentos
Decorrente da publicação da Lei n.º 25/2011 que vem repor a obrigatoriedade de indicação do preço de venda ao público (PVP) na rotulagem dos medicamentos, foi publicada hoje pelo INFARMED, I.P. a Circular nº 114/CD, que visa clarificar a implementação da referida Lei através de regulamentação adicional.
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Actualização das Tabelas n.º 1 e 2 da Portaria n.º 1471/2004, de 21 de Dezembro.
O INFARMED I.P. publicou a Circular Informativa nº 112/CD, de 21/06/2011, que procede à divulgação da Deliberação do Conselho Directivo nº 110/CD/2011.
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Lei nº 25/2011, de 16 de Junho
Foi publicada em Diário da República de 16/06/2011 a Lei nº 25/2011, de 16 de Junho, que estabelece a obrigatoriedade da indicação do preço de venda ao público (PVP) na rotulagem dos medicamentos e procede à quarta alteração ao DL nº 176/2006, de 30 de Agosto, e revoga o artigo 2º do DL nº 106-A/2010, de 1 de Outubro.
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Aquisição directa de medicamentos
O INFARMED I.P. publicou a Circular Informativa nº 109/CD, de 15/06/2011, sobre a concessão de autorização de aquisição directa de medicamentos aos fabricantes, importadores ou distribuidores por grosso por parte das clínicas e consultórios dentários, clarificando o Ponto 4 da Deliberação 016/CD/2010, de 28 de Janeiro.
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Lei nº 26/2011, de 16 de Junho
Foi publicada em Diário da República de 16/06/2011 a Lei nº 26/2011, de 16 de Junho, que estabelece alterações ao regime de transferência de farmácias (primeira alteração ao DL nº 307/2007, de 31 de Agosto).
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Sistema de Preços de Referência
O INFARMED I.P. publicou a Circular Informativa nº 111/CD, de 15/06/2011, que actualiza o SPR na comparticipação de medicamentos pelo SNS válido para o 3º trimestre de 2011.
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Preços e menções nas embalagens dos medicamentos comparticipados
O INFARMED I.P. publicou a Circular Informativa nº 099/CD, de 02/06/2011, com actualização da informação sobre os preços e menções a constar nas embalagens dos medicamentos comparticipados.
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Produtos Cosméticos - Regulamento CE 1223/2009
O INFARMED I.P. publicou a Circular Informativa nº 098/CD, de 01/06/2011, sobre a nova legislação dos Produtos Cosméticos, o Regulamento (CE) nº 1223/2009, providenciando esclarecimento sobre as disposições transitórias e derrogatórias e datas de entrada em vigor.
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Medicamento Parkadina (Amantadina) regressa ao mercado
O Gabinete de Imprensa do INFARMED I.P. divulgou hoje uma Nota Informativa sobre a ruptura de stock do medicamento Parkadina (Amantadina - 100 mg).
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Certificação da Qualidade
É com enorme satisfação que a Phagecon anuncia aos seus Clientes, Fornecedores e Parceiros que no passado dia 25 de Março de 2011 foi-lhe concedida a CERTIFICAÇÃO pela NP EN ISO 9001:2008, no seguimento da auditoria efectuada pelo Organismo BUREAU VERITAS Certification que declarou que o Sistema de Gestão da Phagecon se encontra de acordo com os requisitos das normas de sistemas de gestão acima mencionadas.
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Portaria nº 198/2011, de 18 de Maio
Foi publicada em Diário da República de 18/05/2011 a Portaria nº 198/2011 que estabelece o regime jurídico a que obedecem as regras de prescrição electrónica, bem como o regime transitório da receita manual de medicamentos, prevendo que até à desmaterialização integral do processo de prescrição electrónica, a receita electrónica é objecto de materialização, i.e., impressão da receita electrónica.
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Portaria nº 193/2011, de 13 de Maio
Foi publicada em Diário da República de 13/05/2011 a Portaria nº 193/2011 que regula o procedimento de pagamento da comparticipação do Estado no preço de venda ao público dos medicamentos dispensados a beneficiários do Serviço Nacional de Saúde que não estejam abrangidos por nenhum subsistema ou que beneficiem de comparticipação em regime de complementaridade.
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EMA - Publicação de Perguntas e Respostas no âmbito do Anexo 11 - Sistemas Computorizados
O Capítulo 4 Documentação das Boas Práticas de Fabrico, assim como o Anexo 11 Sistemas Computorizados, foram revistos a Janeiro de 2011 e a data limite para a sua implementação é 30 de Junho de 2011.
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Site móvel para Prontuáro Terapêutico
Foi publicada hoje a Circular Informativa nº 076/CD, de 09/05/2011, do INFARMED IP, divulgando ao público em geral que está disponível um novo site móvel para acesso via dispositivos móveis (telemóveis e tablets) ao Prontuário Terapêutico e ao Guia dos Medicamentos Genéricos e dos Preços de Referência.
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Medicamento para doença de Parkinson
O Gabinete de Imprensa do INFARMED I.P. divulgou hoje um Esclarecimento sobre a ruptura de stock do medicamento Parkadina (Amantadina - 100 mg) onde refere o seguinte:
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Desconto no preço dos medicamentos
Foi hoje publicada a Circular Informativa nº 073/CD, de 28/04/2011, do INFARMED I.P., que esclarece as farmácias sobre o seguinte:
Para mais informações ou esclarecimentos adicionais, contacte o Departamento de Apoio ao Cliente da Phagecon. Read more
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Prática de preços diferentes dos oficialmente aprovados
Foi hoje publicada a Circular Informativa nº 071/CD, de 26/04/2011, do INFARMED I.P., que esclarece as farmácias e distribudores sobre o seguinte:
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Lei nº 10/2011
Foi publicada em Diário da República a Lei nº 10/2011, de 21 de Abril, que estabelece o regime de dispensa gratuita de medicamentos após alta de internamento, pelos serviços farmacêuticos dos hospitais que integram o Serviço Nacional de Saúde (SNS), independentemente do seu estatuto jurídico.
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Fastum, 25mg/g, Gel Reintrodução no mercado
Por meio da Circular Informativa nº 63/CD, o INFARMED I.P. divulga que foi autorizada a reintrodução no mercado do medicamento Fastum, 25mg/g, Gel, na sequência da alteração da sua classificação quanto à dispensa para medicamento sujeito a receita médica (MSRM) e das alterações às secções relevantes do Resumo das Características do Medicamento (RCM), da Rotulagem e do Folheto Informativo (FI).
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Listagem de dispositivos médicos para diagnóstico in vitro
Na sequência de vários pedidos de informação, provenientes de diversas Organizações e Instituições de Saúde, relativos aos vários testes rápidos disponíveis no mercado português para a detecção do vírus do HIV, o INFARMED I.P. refere que se tornou evidente a importância da existência de informação actualizada, que possibilite uma resposta imediata a solicitações relacionadas com este tipo de dispositivos.
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Documentos indispensáveis ao Distribuidor de Dispositivos Médicos
O Infarmed publicou hoje a Circular Informativa nº 054/CD, de 31/03/2011, que visa estabelecer quais os documentos indispensáveis que um Distribuidor de Dispositivos Médicos deverá manter relativamente aos Dispositivos Médicos que distribui.
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Apresentações essenciais para a submissão de pedidos de comparticipação
O Infarmed publicou hoje a Circular Informativa nº 057/CD, de 31/03/2011, que visa tornar mais eficiente o processo de avaliação dos pedidos de comparticipação, pela disponibilização de uma base de dados que pretende ser uma orientação para os requerentes sobre quais as apresentações consideradas essenciais para o cumprimento do respectivo RCM, à luz do actual conhecimento, para a submissão de pedidos de comparticipação conformes.
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Decreto-Lei nº 47/2011 - Ministério da Saúde
Foi publicado hoje em Diário da República o Decreto-Lei nº 47/2011, de 31 de Março, do Ministério da Saúde, que altera a lista de substâncias activas que podem ser incluídas em produtos biocidas, tendo em vista a protecção da saúde humana e animal e a salvaguarda do ambiente, transpõe as Directivas n.os 2010/50/UE, de 10 de Agosto, 2010/51/UE, de 11 de Agosto, 2010/71/UE e 2010/72/UE, de 4 de Novembro, e 2010/74/UE, de 9 de Novembro, todas da Comissão, e procede à sétima alteração ao Decreto-Lei n.º 121/2002, de 3 de Maio.
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Despacho nº 5197/2011
Foi publicado em Diário da Reública de 25/03/2011 o Despacho nº 5197/2011 conjunto dos Ministérios da Economia da Inovação e do Desenvolvimento e da Saúde, que aprova os preços de referência unitários dos grupos homogéneos, para vigorar no trimestre civil que se inicia em 1 de Abril de 2011, no âmbito do regime geral das comparticipações do Estado no preço dos medicamentos.
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Preços e menções a constar nas embalagens dos medicamentos comparticipados actualização
Preços e menções a constar nas embalagens dos medicamentos comparticipados actualização
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Atorvastatina Farmoz - proibição de comercialização
Foi hoje publicada a Circular Informativa nº 50/CD, de 23/03/2011, do INFARMED I.P., que chama a atenção das Farmácias e Distribuidores para o seguinte:
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Portaria nº 112-B/2011, de 22 de Março
Foi publicada em Diário da República a Portaria nº 112-B/2011, de 22 de Março, que estabelece o adiamento pelo período de 3 meses, automaticamente renovável por igual período, da revisão anual de preços do ano de 2011.
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Grupos homogéneos - rectificação da lista 2º Trimestre 2011
O anexo da Deliberação n.º 045/CD/011, de 3 de Março de 2011, saiu com inexactidões relativamente à designação dos grupos homogéneos que integram a lista a vigorar no trimestre civil que se inicia em 1 de Abril de 2011. Por conseguinte, o Infarmed procede à divulgação da Deliberação do Conselho Directivo que aprova a lista rectificada dos Grupos Homogéneos, que entram em vigor no dia 1 de Abril de 2011.
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Despacho nº 4841/2011, de 18 de MarçoO Despacho do Ministério da Saúde agora publicado determina que a SPMS - Serviços Partilhados do Ministério da Saúde, E. P. E. (SPMS, E. P. E.), divulgue, através do Catálogo de Aprovisionamento Público da Saúde (Catálogo), no site www.catalogo.min-saude.pt, todas as características dos produtos abrangidos por contratos públicos de aprovisionamento (CPA), que estabelecem as condições de fornecimento de medicamentos anti-infecciosos. Read more
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Comunicação do horário de funcionamento da farmácia até 31 de Março
Conforme divulgado na Circular informativa n.º 002/CD de 12/01/2011, as farmácias têm, obrigatoriamente, que comunicar o horário de funcionamento para o 2.º semestre de 2011 até 31 de Março de 2011, mesmo que este não sofra alterações.
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Notificação electrónica dos preços dos medicamentos
Notificação electrónica dos preços decorrente da publicação da Portaria n.º 312-A/2010, de 11 de Junho.
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Medicamentos Órfãos
Foi publicada uma Nota Informativa do INFARMED I.P. sobre Medicamentos Órfãos, onde se afirma que o acesso dos doentes a este tipo de medicamentos está garantido.
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BUSCAMED - Directório Online de Medicamentos
A Zeone Informática, Lda., PME que opera no segmento das tecnologias de informação e empresa parceira da Phagecon, face às inúmeras mudanças de preço verificadas no circuito nacional do medicamento, a retirada do preço das embalagens e alguma confusão gerada nos profissionais e no público em geral, decidiu dar o seu contributo, no âmbito da sua política de responsabilidade social, criando, com a consultoria e validação técnico-regulamentar da Phagecon, um Directório Online de Medicamentos - BUSCAMED - www.buscamed.com.pt, também disponível em versão adaptada a smartphones para que todos possam pesquisar o preço dos medicamentos, a qualquer momento e sempre que necessário.
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Revisão excepcional de preço dos medicamentos
Foi hoje publicado o Despacho nº 2826/2011 dos Ministérios da Economia, da Inovação e do Desenvolvimento e da Saúde que define os critérios, prazos e demais procedimentos que presidem à revisão de preço dos medicamentos.
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Prescrição de medicamentos
Presidente da República não promulgou diploma do Governo sobre prescrição de medicamentos
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Medicamentos Manipulados - comparticipação
Foi publicada a Circular informativa nº 007/CD de 21/01/2011 com a seguinte informação:
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Caducidade da comparticipação por não comercialização
Foi publicada a Circular informativa nº 015/CD de 02/02/2011 que determina o seguinte:
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Medicamentos - stocks mínimos
Foi publicada a Circular informativa nº 014/CD de 31/01/2011 que anuncia a publicação da Deliberação nº 021/CD/2011 de 31 de Janeiro do Conselho Directivo do INFARMED I.P., que revoga a recente Deliberação nº 171/CD/2010, estabelecendo o seguinte:
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Medicamentos com Cetoprofeno - recolha temporária do mercado e passagem a MSRM
Foi publicada a Deliberação nº 003/CD/2011 do Conselho Directivo do INFARMED I.P., que decidiu sobre a recolha temporária do mercado e passagem a MSRM de medicamentos contendo a substância activa Cetoprofeno - uso tópico.
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Despacho nº 1845/2011 do Ministério da Saúde
O despacho nº 20510/2008, de 24 de Julho, definiu as condições de dispensa e utilização de medicamentos prescritos a doentes com artrite reumatóide, espondilite anquilosante, artrite psoriática, artrite idiopática juvenil poliarticular e psoríase em placas.
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Publicação de novo Anexo 11 das BPF Sistemas Computorizados
O anexo 11 do EU GMP Guide é o documento base que regulamenta os sistemas computorizados no âmbito das BPF. Durante muito tempo este documento não sofreu alterações, não reflectindo na totalidade os desenvolvimentos que ocorreram nesta área.
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Publicação do novo Capítulo 4 das BPF - Documentação
Esta revisão surge na sequência da publicação em simultâneo do novo Anexo 11 Sistemas Computorizados, acrescentando no entanto outras alterações significativas.
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Criação de centros de investigação de ensaios clínicos
Foi publicada em Diário da República a Resolução da Assembleia da República nº 2/2011 que recomenda ao Governo a criação de centros de investigação de ensaios clínicos, da seguinte forma:
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Pesquisa Medicamento - Informação directa ao Cidadão
O Gabinete de Imprensa do INFARMED IP emitiu em 13-01-2011 uma nota informativa sobre a nova ferramenta de pesquisa de medicamentos disponível no sítio online da Autoridade. Destacam-se os seguintes pontos:
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Farmácia de oficina - comunicação do horário de funcionamento
Foi publicada a Circular Informativa nº 002/CD, de 12 /01/2011, do INFARMED I.P., que fornece esclarecimentos sobre a forma de comunicação do horário de funcionamento da farmácia de oficina - Ciclo de Vida da Farmácia e do Local de Venda de Medicamentos Não Sujeitos a Receita Médica - CIVIFAR/CIVILOC.
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Distribuidores por Grosso e Farmácias - Fornecimento de medicamentos: quantidades mínimas de stock e período de tempo para fornecimento aos utentes.
O INFARMED I.P. no uso da sua competência regulamentar publicou a Deliberação n.º 171/CD/2010 que define os critérios de determinação das quantidades mínimas de medicamentos que devem ser mantidas permanentemente pelos distribuidores por grosso e o período de tempo que as farmácias deverão cumprir junto dos seus utentes para o fornecimento dos mesmos.
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Regulamentação do DL nº 7/2011, de 10 de Janeiro
Foi publicada a Portaria nº 31-A/2011, de 11 de Janeiro que regulamenta o DL nº 7/2011, de 10 de Janeiro da seguinte forma:
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Período de abertura das farmácias - 24h/dia
Foi publicado o Decreto-Lei nº 7/2011, de 10 de Janeiro que regula sobre o período de funcionamento das farmácias de oficina.
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Medicamentos comparticipados - preços e menções a constar nas embalagens
Circular Informativa nº 225/CD, de 23/12/2010, do INFARMED I.P.
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Despacho nº 18694/2010 do Ministério da Saúde
Foi publicado o Despacho nº 18694/2010, de 16 de Dezembro, do Ministério da Saúde, que estabelece as condições de comparticipação de medicamentos manipulados e aprova a respectiva lista.
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Portal online das Farmácias (CIVIFAR)
O INFARMED I.P. criou uma nova ferramente online para as Farmácias:
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Despacho nº 18419/2010 do Ministério da Saúde
Foi publicado o Despacho nº 18419/2010, de 13 de Dezembro, do Ministério da Saúde, que determina que os medicamentos destinados ao tratamento de doentes com artrite reumatóide, espondilite anquilosante, artrite psoriática, artrite idiopática juvenil poliarticular e psoríase em placas beneficiam de um regime especial de comparticipação.
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Amostras gratuitas de medicamentos
Têm chegado ao conhecimento do INFARMED situações de fornecimento de amostras gratuitas de medicamentos por parte da Industria Farmacêutica aos Hospitais do Serviço Nacional de Saúde (SNS), enquanto ainda não existe decisão do pedido de avaliação prévia, nos termos do Decreto-Lei n.º 195/2006, de 3 de Outubro, para efeitos de aquisição do medicamento por esses hospitais. Como é sabido, na falta desta avaliação favorável, o medicamento não pode ser adquirido pelos Hospitais do SNS.
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Dispositivos Médicos - Certidão comprovativa de registo online
Atendendo à obrigatoriedade de notificação das actividades de fabrico e distribuição por grosso de dispositivos médicos, o INFARMED IP alterou o procedimento de pedido de certidão comprovativa do registo de dispositivos médicos.
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Renovações de AIM - Alterações ao procedimento nacional
A 1 de Janeiro de 2011, o INFARMED I.P. vai implementar algumas novas medidas aplicáveis à verificação de conformidade dos pedidos de renovação de AIM por procedimento nacional.
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Utilização de medicamentos off-label
O INFARMED I.P. esclarece o seguinte:
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Escoamento embalagens medicamentos (Portaria nº 1041-A/2010, de 7 de Outubro)
Contextualização
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Alterações Tipo II de Segurança - Actualização instruções INFARMED I.P.
Foi publicada a Circular Informativa Nº 165/CD de 20/10/2010 do INFARMED I.P., que veio dar instruções aos Requerentes sobre a actualização do Manual de Submissão Electrónica de Alterações Tipo II de Segurança solicitadas pelo INFARMED I.P. em procedimentos nacionais.
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Grupos farmacoterapêuticos nos diferentes escalões de comparticipação
Foi publicada a Portaria nº 924-A/2010, de 17 de Setembro, do Ministério da Saúde, que veio regulamentar sobre os grupos e sub-grupos farmacoterapêuticos que integram os diferentes escalões de comparticipação.
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Política do Medicamento novas medidas aprovadas em Conselho de Ministros
Nova Política do Medicamento medidas aprovadas em Conselho de Ministros
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Dispensa de medicamentos em unidose - Adesão pela farmácia
As farmácias que pretendam proceder à dispensa de medicamentos em quantidade individualizada, têm que o solicitar ao Infarmed.
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Prazos de escoamento de medicamentos devido à alteração da taxa do IVA de 5% para 6%
No âmbito da alteração da taxa de IVA e da simultânea revisão anual de preços o Infarmed informa que não é necessário efectuar a remarcação das embalagens de medicamentos cujo preço foi alterado, decorrente apenas da alteração da taxa de IVA e que já se encontravam no circuito de distribuição (distribuidores grossistas e farmácias) em 30 de Junho de 2010, para os medicamentos de marca, ou 31 de Julho de 2010, para os genéricos. Assim, o escoamento destes medicamentos pode ocorrer até ao final do prazo de validade, deixando de se considerar o prazo de 60 dias referido na Circular Informativa N.º 108/CD de 07/07/2010.
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Implementação do e-CTD em Portugal - Deliberação nº 102/CD/2010 do INFARMED I.P.
Foi publicada a Deliberação nº 102/CD/2010, de 1 de Julho que regula a implementação do e-CTD em Portugal e esclarece sobre os procedimentos a adoptar para a fase transitória.
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Medicamentos Genéricos - Cálculo do PVP
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Medicamentos unidose nas farmáciasFoi publicada a Portaria n.º 455-A/2010, de 30 de Junho que regula a dispensa de medicamentos ao público, em quantidade individualizada, nas farmácias de oficina ou nas farmácias de dispensa de medicamentos ao público instaladas nos hospitais do Serviço Nacional de Saúde concessionadas ao abrigo do disposto no Decreto-Lei n.º 241/2009, de 16 de Dezembro, revogando a Portaria n.º 697/2009, de 1 de Julho. Read more
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Dispositivos médicos destinados ao controlo da diabetes Alteração da taxa do IVA
No próximo dia 1 de Julho, haverá aumento da taxa do IVA, aplicável aos dispositivos médicos comparticipados destinados ao controlo da Diabetes, de 5% para 6%, com o consequente aumento do Preço de Venda ao Público (PVP).
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PVP dos medicamentos - procedimentos a adoptar
Medicamentos genéricos - para obviar eventuais rupturas no abastecimento e evitar uma dupla marcação dos PVP no curto espaço de tempo de 1 mês, podem-se praticar PVP que, em resultado da nova taxa de IVA, são superiores aos que se encontram inscritos nas respectivas embalagens.
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Preço dos medicamentos - clarificação sobre as novas regras.
Alteração à Portaria nº 312-A/2010, de 11 de Junho. Foi publicada a Portaria nº 337-A/2010, de 16 de Junho, que vem clarificar as dúvidas suscitadas a propósito do teor do nº1 do artigo 5º da Portaria nº 312-A/2010, de 11 de Junho.
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Preço dos medicamentos - notificação electrónica.
Notificação electrónica dos preços decorrente da publicação da Portaria nº 312-A/2010, de 11 de Junho.
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Preço dos medicamentos - novas regras.
Foi publicada a Portaria nº 312-A/2010, de 11 de Junho, que procede a um ajustamento da regulamentação, estabelecendo novas regras de formação dos preços dos medicamentos, sua alteração e revisão anual.
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Phagecon - Novo website
Em destaque:
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Phagecon - Nova morada
O dia 1 de Abril de 2010 marca o ínicio de actividade da Phagecon em novas instalações: mais modernas, mais espaçosas e com melhores condições e acessos para os nossos colaboradores, clientes e parceiros. Todos os restantes contactos (telefone/fax/e-mail) se mantém inalterados.
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