PHAGECON

DAILY RELEVANT REGULATORY NEWS


EMA publishes Comments on ICH E2D The 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 05-09-2024
EMA/CHMP: New Guideline Draft on Active Substances published for Comment As 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 03-09-2024
The Effectiveness of Disinfectant Agents: An Overview Disinfectants 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 27-08-2024
ECA Guidance on Visual Inspection of Parenterals Participants 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 21-08-2024
EMA/CMDh: Q&A Document Nitrosamines revised In 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 20-08-2024
How to document a Product Transfer? Get Example Templates According 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 26-07-2024
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 24-07-2024
Pilot Results on Regulatory-Led RWE Generation Results 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 23-07-2024
Templates for Shortage Prevention and Mitigation Plans issued by EMA On 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 17-07-2024
New Measures to Report Medicine Disappearances According 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 16-07-2024
EMA: Q&A document for "Centralised Procedures" updated again In 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 12-07-2024
New Ph. Eur. Chapter on Elemental Impurities in Plastic Materials The 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 09-07-2024
Council of Europe adopts recommendation on reporting of disappearances of medicines In 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 04-07-2024
First nasal adrenaline spray for emergency treatment against allergic reactions EMA’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 01-07-2024
New guidance on the clinical evaluation of orphan medical devices published Read more 26-06-2024
Requirements for Sterile Packaging Material The 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 04-06-2024
ICH Q3C: New Version of the Guideline for Residual Solvents published Since 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 29-05-2024
EMA: Update of the Annex to the Excipients Guideline In 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 28-05-2024
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 22-05-2024
ICH Q3C: New Version of the Guideline for Residual Solvents published Since 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 14-05-2024
Recommendations from EMA to strengthen supply chains of critical medicines published On 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 07-05-2024
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 03-05-2024
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 30-04-2024
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 29-04-2024
APIC: Best Practices Guide for dealing with Suppliers The "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 26-04-2024
New recommendations to strengthen supply chains of critical medicines EMA 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 24-04-2024
Unexpected Deviations: the Role of the QP Annex 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 23-04-2024
Critical medicine shortages - immediate workflow and trial phase with two ongoing shortages The 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 22-04-2024
European Pharmacopoeia to put an end to all animal tests for histamine and depressor substances At 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 11-04-2024
APIC: Best Practices Guide for dealing with Suppliers The "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 09-04-2024
Pharmeuropa 36.2 just released All 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 05-04-2024
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 03-04-2024
How CEP holders can avoid the rejection of notifications In 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 01-04-2024
APIC Quality Agreement Guideline: Update published The 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 27-03-2024
EMA/CMDh: Appendix 1 for Nitrosamines Updated Again The 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 18-03-2024
EMA/FDA joint Q&As on Quality and GMP aspects of Breakthrough Therapy Applications The 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 15-03-2024
EDQM: Top Ten Deficiencies for CEPs In 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 12-03-2024
Improving Registration and Reporting Summary Results Information for Clinical Trials The 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 11-03-2024
EMA/CHMP/CVMP: New Q&A document for the Use of CEPs In 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 05-03-2024
Continued efforts needed to fight antimicrobial resistance (AMR) in humans and animals Resistance 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 29-02-2024
The ICH E2D(R1) draft Guideline presentation available now on the ICH website The 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 22-02-2024
Checklist for Implementation of GDP Principles - Part 4: Documentation Chapter 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 20-02-2024
EDQM: Addendum 11.5 to the European Pharmacopoeia available Supplement 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 14-02-2024
EMA/CMDh: Nitrosamine Q&A Document revised 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" 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 06-02-2024
EMA publishes new questions and answers on Annex 1 The 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 30-01-2024
Falsified Medicines in the Legal Supply Chain Falsified 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 25-01-2024
New strategy for N-nitrosamine impurities in Ph. Eur. monographs At its 177th session in November 2023, the European Pharmacopoeia Commission (EPC) approved the strategy for N-nitrosamine impurities in individual monographs. Read more 23-01-2024
EDQM clarifies its policy for confidentiality and declassification of CEP documents EDQM 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 22-01-2024
Update of the EMA Q&A document on Combination Products Combination 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 18-01-2024
EMA/CMDh: Update Q&A Document for Nitrosamines The 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 10-01-2024
ICH Guidelines Q2(R2) "Validation of Analytical Procedures" and ICH Q14 "Analytical Procedure Development" published As 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 09-01-2024
Retirada do PVP nas embalagens dos medicamentos \| Decreto Lei 128/2023, de 26 de dezembro Com 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 08-01-2024
Pharmeuropa 36.1 just released All 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 05-01-2024
Nitrosaminas em medicamentos de uso humano Em 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 26-12-2023
Publicado relatório intercalar da Estratégia da Rede Europeia de Agências de Medicamentos 2020-2025 A 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 22-12-2023
EDQM welcomes EU Parliament and Council’s political agreement on enhanced safety and quality for substances of human origin The 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 21-12-2023
CTR / CTIS Guidance Update The EMA and the HMA published the following revised guidance documents relating to the CTIS transparency rules and the transition of clinical trials. Read more 20-12-2023
EDQM: Updates on CEP Dossiers With 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 19-12-2023
Reports confirm the European Health Union is better prepared to combat health threats Read more 18-12-2023
EU and MHRA extend GMP and GDP Certificates The 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 13-12-2023
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 12-12-2023
First Electronic Product Information (ePI) for Human Medicines The 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 11-12-2023
EMA launches Website for accelerating EU Clinical Trials The 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 28-11-2023
News on CEP 2.0: Specifications Once 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 21-11-2023
EDQM launches updated version of the EuroGTP II tool to ensure good tissue and cell practices for human application To 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 16-11-2023
EDQM: Supplement 11.4 to the European Pharmacopoeia available The 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 14-11-2023
First electronic product information (ePI) published for selected human medicines The 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 09-11-2023
EMA publishes "Toolkit" for Shortages of Medicinal Products The 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 07-11-2023
EMA encourages companies to submit type I variations for 2023 in November 2023 EMA 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 06-11-2023
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 02-11-2023
EU Commission: Strategy Paper with Measures against Medicine Supply Shortages The 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 31-10-2023
Comissão Europeia propõe várias medidas para a prevenção da escassez de medicamentos na Europa A 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 27-10-2023
EMA Publishes revised CTIS Transparency Rules Following 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 26-10-2023
EMA takes further steps to address critical shortages of medicines in the EU EMA 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 25-10-2023
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 18-10-2023
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 17-10-2023
EDQM joins efforts to tackle medicine shortages Medicine 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 12-10-2023
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 10-10-2023
EMA publica revisão das regras de transparência de informações sobre ensaios clínicos A 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 09-10-2023
EMA: Updates in the Product Lifecycle Management (PLM) Portal New 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 06-10-2023
Pharmeuropa 35.4 just released All 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 04-10-2023
EDQM: CEP 2.0 implemented Since 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 03-10-2023
CEP 2.0 – Certificates of suitability: electronic signature features On 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 22-09-2023
Electronic Submission Portal for Cosmetics The 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 19-09-2023
WHO issues draft Guidance on Best Practices for Clinical Trials The World Health Organization (WHO) published a draft guideline on best practices for clinical trials. The deadline for comments is 15 September 2023. Read more 12-09-2023
Validating analytical procedures for determining nitrosamines in pharmaceuticals: European OMCLs participate in collaborative study with international regulatory agencies The 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 11-09-2023
Publication of EMA Document on the Establishment of a Guideline on mRNA Vaccines The 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 05-09-2023
EMA dá parecer positivo a vacina adaptada para COVID-19 As 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 31-08-2023
Renewed Revision of the Q&A Document on Nitrosamine Impurities: temporary acceptable intakes no longer need to be set Only 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 30-08-2023
The possible Impact of Artificial Intelligence on the Role of the Qualified Person Artificial 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 29-08-2023
New EMA Reflection Paper on the use of Artificial Intelligence On 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 24-08-2023
CMDh/HMA: Best Practice Guide on Variations In 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 22-08-2023
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 21-08-2023
Medicamentos contendo valproato: revisão pela EMA dos dados sobre a exposição paterna O 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 18-08-2023
EDQM: Supplement 11.3 to the European Pharmacopoeia available Supplement 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 14-08-2023
FDA´s draft Guidance on Postmarketing Noncompliance The 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 08-08-2023
Adjusting for Covariates in Randomized Clinical Trials The 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 28-07-2023
Remote Access to Study Data in Clinical Trials - What needs to be considered EMA'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 27-07-2023
New EMA Reflection Paper on the use of Artificial Intelligence The 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 26-07-2023
ICH Update on GCP related Topics including RWD/RWE Following 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 25-07-2023
Important update on N-nitrosamine impurities in substances covered by CEPs On 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 24-07-2023
Reflection paper on the use of artificial intelligence in the lifecycle of medicines EMA 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 20-07-2023
European Health Union: EU steps up action to prevent shortages of antibiotics for next winter The 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 18-07-2023
Projeto Piloto eFI (folheto informativo em formato eletrónico): 1ª fase medicamentos de uso exclusivo hospitalar O 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 17-07-2023
Ph. Eur. Update on Pharmaceutical Preparations A 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 11-07-2023
Phasing out of extraordinary COVID-19 regulatory flexibilities Read more 07-07-2023
EMA starts Review of Transparency Rules for the CTIS The 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 05-07-2023
Quality Culture in the Pharmaceutical Industry: Benefits and Challenges The 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 04-07-2023
EMA publishes Comments on ICH M11 CeSHarP The 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 03-07-2023
Dealing with Artificial Intelligence in the Context of the further Development of Software in Medical Devices The 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 29-06-2023
Potential Assays for Monoclonal Antibodies and Other Therapeutic Proteins The 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 27-06-2023
Use of real-world evidence in regulatory decision making – EMA publishes review of its studies Real-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 26-06-2023
Infografia: Notificação de faltas pela farmácia A 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 22-06-2023
EMA starts Review of Transparency Rules for the CTIS The 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 21-06-2023
ICH GCP Draft Guideline Following 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 20-06-2023
The ICH E6(R3) draft Guideline presentation available now on the ICH website The 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 14-06-2023
EMA and ECDC statement on updating COVID-19 vaccines to target new SARS-CoV-2 virus variants The 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 07-06-2023
Boas práticas para a prevenção de ruturas de abastecimento A 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 06-06-2023
New EMA Guidance to prevent and mitigate Medicine Shortages The 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 24-05-2023
Questions and Answers from the ECA Webinar "GDP Update 2023" - Part 2 More 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 23-05-2023
Guidance for industry to prevent and mitigate medicine shortages EMA 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 18-05-2023
New EMA Guidelines and Revisions in GMP Area The 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 17-05-2023
EMA annual report 2022 published EMA 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 16-05-2023
Fluoroquinolone antibiotics: reminder of measures to reduce the risk of long-lasting, disabling and potentially irreversible side effects EMA’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 15-05-2023
EMA updates Timelines of eAFs for Variations for Medicinal Products for Human Use In 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 11-05-2023
Ph. Eur. Commission kicks off elaboration of three general texts on mRNA vaccines and components Messenger 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 05-05-2023
GMP Update: Consequences from the New EU Commission Proposal On 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 03-05-2023
EDQM: Updates on CEP 2.0 As part of the implementation of the new "CEP 2.0", the EDQM has now provided further information on its website. Read more 02-05-2023
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 26-04-2023
Single-arm trials as pivotal evidence for the authorisation of medicines in the EU Read more 24-04-2023
Pharmeuropa: Revised Chapter 2.9.1. "Disintegration of tablets and capsules" published for comment In 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 19-04-2023
Alteração das instruções aos requerentes de pedidos de alteração, renovação e transferência de titular de AIM O 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 18-04-2023
Clinical Trials Regulation - Version 6.4 of the Q&As The 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 11-04-2023
The ICH M7(R2) Guideline reaches Step 4 of the ICH Process The 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 10-04-2023
ICH Information Material on the ICH Q9 revision Quality Risk Management Since 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 05-04-2023
EU recommendations for 2023-2024 seasonal flu vaccine composition EMA 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 04-04-2023
11th Edition of The International Pharmacopoeia The 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 30-03-2023
ECHA reviews extended one-generation reproductive toxicity studies and recommends good practices In a review of 55 extended one-generation reproductive toxicity (EOGRT) studies, ECHA confirms their effectiveness in identifying substances of concern. Read more 28-03-2023
Advancing regulatory science in the EU – mid-point report published EMA 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 23-03-2023
EDQM: New CEP 2.0 The 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 22-03-2023
CEP 2.0: Use of EMA SPOR/OMS ORG_ID and LOC_ID mandatory for CEP applications As 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 20-03-2023
Remote and online provision of medicines: EDQM targeted stakeholder consultation From 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 16-03-2023
HERA signs agreement with ECDC and with EMA to strengthen cooperation on health emergency preparedness and response Read more 14-03-2023
Clinical Trials Regulation - Version 6.3 of the Q&As The 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 13-03-2023
EDQM: Supplement 11.2 of the European Pharmacopoeia available Supplement 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 07-03-2023
Recommendations on Decentralized Elements in Clinical Trials The 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 02-03-2023
EDQM: Updated List of Reference Substances The 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 01-03-2023
EMA pilots scientific advice for certain high-risk medical devices EMA 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 28-02-2023
Qualification of Customers - What needs to be considered? Wholesale distributors must verify that their customers are authorised to purchase medicinal products. Read more 22-02-2023
Consultation on Multi-Stakeholder Platform for improving EU Clinical Trials The 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 17-02-2023
EU Survey on the Implementation of the Clinical Trial Regulation From 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 16-02-2023
The new ICH Q9 Revision on Quality Risk Management becomes Effective as of 23 July 2023: A Detailed Analysis Earlier 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 15-02-2023
Public Consultation on two Ph. Eur. Chapters on Pharmaceutical Technology Procedures The 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 14-02-2023
PRAC starts safety review of pseudoephedrine-containing medicines EMA’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 13-02-2023
CEPs: EDQM establishes New Procedure By 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 08-02-2023
Actions to support the development of medicines for children Regulators 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 07-02-2023
Public consultation on a multi-stakeholder platform to improve clinical trials in the EU On 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 06-02-2023
Updated ICH E2B(R3) Q&As on ICRs On 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 02-02-2023
Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU From 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 01-02-2023
CEP holders – How to submit a nitrosamine risk assessment To 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 31-01-2023
EMA update on shortages of antibiotics in the EU EMA'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 27-01-2023
Update of the EMA Q&As on GDP Requirements The 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 26-01-2023
ICH Q13: Final Version of Guideline for Continuous Manufacturing published Back 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 25-01-2023
EMA: IRIS Guides Revised Again At 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 24-01-2023
Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines Read more 23-01-2023
Implementation of the European Pharmacopoeia Supplement 11.2 – Notification for CEP holders Supplement 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 20-01-2023
Update on the EMA Checklists for Changes & Variations The 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 18-01-2023
Update on the EMA Guidance for Applicants/MAHs involved in GCP Inspections The 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 17-01-2023
ICH Q3C: Corrected Version of the Guideline for Residual Solvents Published Since 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 11-01-2023
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 abril O 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 10-01-2023
Ph. Eur. Commission adopts revised general monographs 2034 and 2619 after inclusion of new paragraph on control of N-nitrosamines At 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 09-01-2023
Pharmeuropa 35.1 just released All 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 03-01-2023
ICH M13 draft Guideline reaches Step 2 of the ICH process The 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 22-12-2022
Expert Task Force issues new Version of CCS Guideline Past 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 20-12-2022
Revised general chapter on rubber closures published in the Ph. Eur. Supplement 11.1 The 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 19-12-2022
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 15-12-2022
USP issues Chapter "Elemental Impurities-Limits" for Comments The 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 14-12-2022
EMA Evaluates Access to Raw Data from Clinical Trials The 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 13-12-2022
ETF warns that monoclonal antibodies may not be effective against emerging strains of SARS-CoV-2 EMA’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 12-12-2022
Autorização de comercialização de medicamentos sem autorização ou registo válidos em Portugal (SAR): revisão do procedimento Conforme 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 09-12-2022
EMA recommends withdrawal of pholcodine medicines from EU market EMA’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 05-12-2022
Real-World Data: EMA´s Good Practice Guide The 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 30-11-2022
Expected publication dates of PRAC recommendations on safety signals Read more 29-11-2022
Amendment to the CTR on IMP Labelling As 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 23-11-2022
Best practices to fight antimicrobial resistance The 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 22-11-2022
EMA: Q&A Documents on Centralised Procedures updated again The 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 17-11-2022
APIC: New Update of the ICH Q7 "How to do" Document The 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 16-11-2022
Temperature Mapping for the Qualification of Storage Areas In 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 15-11-2022
New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome On 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 14-11-2022
Vulnerabilities in global Supply Chains: Reasons and possible Solutions The 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 09-11-2022
EMA publishes ICH M11 (CeSHarP) for Comments The 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 08-11-2022
Recomendações sobre medidas de minimização do risco de reações adversas graves: medicamentos da classe de Inibidores das JAK usados em doenças inflamatórias O 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 04-11-2022
EMA recommends measures to minimise risk of serious side effects with Janus kinase inhibitors for chronic inflammatory disorders Read more 03-11-2022
ICH M11 guideline, clinical study protocol template and technical specifications The 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 27-10-2022
Nitrosamine Impurities: Further Update of EMA's Question and Answer Document The 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 25-10-2022
ICH M11 draft Guideline reaches Step 2 of the ICH process The 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 24-10-2022
EMA divulga novas recomendações para aprovação de vacinas COVID-19 O 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 20-10-2022
EDQM Publishes new Document on Revised Ph. Eur. General Chapter 2.2.46. Chromatographic Separation Techniques A 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 19-10-2022
New vaccine to protect people in the EU and worldwide against dengue EMA’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 17-10-2022
EMA lança uma consulta pública sobre o guia de boas práticas para a utilização do catálogo de meta-dados do mundo real Em 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 14-10-2022
Shortages and Crisis Preparedness: EMA Publishes List of the Main Therapeutic Groups of Medicinal Products On 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 13-10-2022
USP: Stimuli Article on Mutagenic Impurities published for Comments Since 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 12-10-2022
List of Documents Needed during GVP Inspections The 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 06-10-2022
Implementation of the European Pharmacopoeia Supplement 11.1 – Notification for CEP holders Supplement 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 04-10-2022
New recommendations for terlipressin-containing medicines in the treatment of hepatorenal syndrome 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 (HRS-1) (kidney problems in people with advanced liver disease). Read more 03-10-2022
EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products EMA 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 30-09-2022
Avaliação do risco de presença de nitrosaminas nos medicamentos/ Review on the risk of nitrosamine impurities in human medicines A 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 29-09-2022
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 28-09-2022
European Pharmacopoeia Supplement 11.1 now available The 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 23-09-2022
EMA e HMA confirmam interpermutabilidade dos medicamentos biossimilares A 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 21-09-2022
Labeling Requirements for IMPs Amended Following 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 20-09-2022
Publication of revised PIC/S Annex 1 The 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 19-09-2022
EMA recommends standard marketing authorisations for Comirnaty and Spikevax COVID-19 vaccines EMA’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 16-09-2022
GDP Non-Compliance Report: No GDP conform Quality System The 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 15-09-2022
Adapted vaccine targeting BA.4 and BA.5 Omicron variants and original SARS-CoV-2 recommended for approval EMA’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 13-09-2022
Revised OCABR Guideline for Pandemic COVID-19 vaccine (mRNA) now available The 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 08-09-2022
EMA Publishes Comments Received on ICH Q2(R2) and Q14 In 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 07-09-2022
New general chapter on implementation of pharmacopoeial procedures published in the 11th Edition of the European Pharmacopoeia A 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 05-09-2022
EMA recomenda primeiras vacinas COVID-19 adaptadas O 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 02-09-2022
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 31-08-2022
Great Britain plans a New "Mark" for Medical Products as a Replacement to the CE Mark With 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 30-08-2022
EMA starts review of conditional marketing authorisation application for Skycovion COVID-19 vaccine EMA’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 19-08-2022
Nitrosamine Impurities: Extension of the Deadline for the Submission of Variations EMA'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 17-08-2022
CTIS & EudraVigilance - Update for Sponsors of Clinical Trials The 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 16-08-2022
USP-NF Stimuli Article on Consistent NMR Terminology In 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 27-07-2022
EMA recommends approval of Imvanex for the prevention of monkeypox disease EMA’s human medicines committee (CHMP) has recommended extending the indication of the smallpox vaccine Imvanex to include protecting adults from monkeypox disease. Read more 25-07-2022
Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making EMA 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 22-07-2022
EMA updates eAFs for Variations for Medicinal Products for Human and Veterinary Use The 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 21-07-2022
The latest Updates of the EMA's Question and Answer Document on Nitrosamine Contamination After 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 20-07-2022
Towards better prevention of medicine shortages in the EU EMA 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 15-07-2022
EMA launches pilot project on analysis of raw data from clinical trials EMA 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 13-07-2022
ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines The 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 12-07-2022
Further measures to identify and address medicine shortages during public health emergencies adopted On 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 11-07-2022
Pharmeuropa 34.3 just released All 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 08-07-2022
Drug Shortages: EMA asks Companies to register a Single Point of Contact Marketing 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 06-07-2022
Global regulators agree on key principles on adapting vaccines to tackle virus variants On 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 04-07-2022
CTIS & EudraVigilance - Update for Sponsors of Clinical Trials The 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 01-07-2022
Monkeypox: EMA starts review for Imvanex EMA’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 29-06-2022
First gene therapy to treat severe haemophilia A EMA 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 27-06-2022
EMA: Another Update of the Q&As on Parallel Distribution Already 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 22-06-2022
New Guidance Documents for GCP Inspections On 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 21-06-2022
MHRA introduces external consultants as Compliance Monitors in Companies The 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 08-06-2022
New Version of the ICH Q3D Guideline for Impurities published Since 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 25-05-2022
EMA guidance supports development of new antibiotics As 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 24-05-2022
EMA tackles the Issue of Remote Batch Certification EMA 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 18-05-2022
List of Documents Needed during GCP Inspections The 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 17-05-2022
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 13-05-2022
Classification of Packaging Changes Prior 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 11-05-2022
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 10-05-2022
Update of the EMA Q&As on parallel Distribution of Medicinal Products The 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 06-05-2022
Comments on the new ICH Q9 Guideline Q9 (Quality Risk Management) published Since 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 04-05-2022
MHRA Releases New Version of the Green Guide The 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 22-04-2022
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 20-04-2022
Outcome of the 172nd session of the European Pharmacopoeia Commission, March 2022 The 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 12-04-2022
ECDC e EMA emitem parecer sobre quartas doses de vacinas de mRNA COVID-19 O 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 07-04-2022
ICH Guidance Q14 / Q2(R2) - Analytical Method Development/Method Validation Published for Consultation The 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 06-04-2022
Centralised Procedures: Update of the Q&A Document In 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 05-04-2022
Pharmaceutical industry provides unpublished data on chemical substances Previously 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 04-04-2022
EMA establishes Cancer Medicines Forum with academia to optimise cancer treatments in clinical practice EMA, 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 01-04-2022
Active substance-derived nitrosamines Read more 31-03-2022
New gene therapy to treat adult patients with multiple myeloma EMA 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 28-03-2022
How often should GDP Self-Inspections be performed? According to the GDP guidelines, regular self-inspections should be performed. Read more 18-03-2022
Revision of the PIC/S GMP Guide The 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 16-03-2022
Updated Guidance relating to Clinical Trials during the COVID-19 Pandemic The 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 15-03-2022
Information Duties and Responsibilities of CEP Holders - the new EDQM Public Document Marketing 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 09-03-2022
Sessão de informação: Introdução à OMS e RMS para utilizadores do CTIS da Indústria Farmacêutica e Centros de Ensaio A 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 07-03-2022
New WHO Guidance on Data Integrity In 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 02-03-2022
Hydroxyethyl-starch solutions for infusion recommended for suspension from the market On 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 28-02-2022
EMA recomenda aprovação da vacina Spikevax para crianças dos 6 aos 11 anos O 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 25-02-2022
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 23-02-2022
Final EMA Guidelines on Quality Requirements for IMPs The 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 17-02-2022
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 16-02-2022
Active and Passive Shipping Systems and Transport Equipment In 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 15-02-2022
Recomendação de suspensão do mercado das AIM das soluções para perfusão de hidroxietilamido O 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 14-02-2022
Consideration on core requirements for RMPs of COVID-19 vaccines Read more 10-02-2022
EU: Strengthening the EMA A 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 09-02-2022
Vacinas administradas noutros países A vacinação contra a COVID-19 é uma prioridade global para a proteção da saúde pública. Read more 08-02-2022
Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP Read more 04-02-2022
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 03-02-2022
GMP Requirements for Supplier Qualification Supplier 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 02-02-2022
A stronger role for EMA The 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 01-02-2022
New gene therapy treatment for patients with relapsed or refractory large B-cell lymphoma EMA 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 31-01-2022
EMA publishes Guidance on Companion Diagnostics As 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 28-01-2022
EMA: Draft Guidance for Centralised Procedures open for Comments In 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 26-01-2022
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 25-01-2022
International regulators’ recommendations on COVID-19 vaccines and the Omicron variant International 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 24-01-2022
Implementation of the European Pharmacopoeia Supplement 10.8 – Notification for CEP holders Supplement 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 21-01-2022
EMA: Draft Guidance for Centralised Procedures open for Comments In 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 19-01-2022
The GDP Non-Compliance Reports of 2021 - An Overview Wholesale 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 18-01-2022
Novo Regulamento Europeu de Ensaios Clínicos entra em aplicação a 31 de janeiro A 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 13-01-2022
Proposal for New General USP Chapter on Quality Attributes of Starting Materials for the Chemical Synthesis of Therapeutic Peptides In 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 12-01-2022
EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19 Read more 11-01-2022
Pharmeuropa 34.1 just released All 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 05-01-2022
Publicado Regulamento (UE) 2021/2282 do Parlamento Europeu e do Conselho relativo à avaliação das tecnologias da saúde Foi 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 23-12-2021
WHO publishes Guidance on Safe Production and Quality Control of Monoclonal Antibodies As 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 21-12-2021
Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics Read more 20-12-2021
COVID-19 - EMA recomenda autorização de dois medicamentos O 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 17-12-2021
Guideline on the acceptability of names for human medicinal products processed through the centralised procedure Based 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 16-12-2021
CEPs: New IT Application of the EDQM In 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 15-12-2021
ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk This 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 14-12-2021
International regulators stress continued need for COVID-19 therapeutics EMA 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 10-12-2021
APIC: Update of the ICH Q7 "How to do" Document The 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 09-12-2021
How to use Real-World Data for Benefit-Risk Assessment Following 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 07-12-2021
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 03-12-2021
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 02-12-2021
WHO publishes Guidance on Safe Production and Quality Control of Monoclonal Antibodies As 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 30-11-2021
Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11 EMA’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 26-11-2021
A vision for use of real-world evidence in EU medicines regulation Enabling 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 25-11-2021
EMA receives application for marketing authorisation for Lagevrio (molnupiravir) for treating patients with COVID 19 EMA 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 24-11-2021
GDP Certificates and Wholesale Authorisations Automatically Extended until the End of 2022 In 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 23-11-2021
EMA starts review of Paxlovid for treating patients with COVID-19 EMA 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 22-11-2021
EMA receives application for marketing authorisation for Xevudy (sotrovimab) for treating patients with COVID-19 EMA 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 19-11-2021
EMA receives application for conditional marketing authorisation of Novavax’s COVID-19 vaccine, Nuvaxovid EMA 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 18-11-2021
First-in-class medicine recommended for treatment of rare blood vessel inflammation EMA 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 15-11-2021
ICH S1B Carcinogenicity: testing for carcinogenicity of pharmaceuticals Guidance 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 12-11-2021
Compassionate Use: EMA supports Submission of Medicinal Product Information To 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 09-11-2021
HMA e EMA lançam piloto para promover o reposicionamento de medicamentos Os 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 04-11-2021
EU: Important Document for Inspections revised The 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 03-11-2021
Regulatory update - EMA encourages companies to submit type I variations for 2021 in November 2021 The 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 02-11-2021
How to submit information Marketing-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 29-10-2021
Written GDP Training Programme: What does this mean in Practice? Chapter 2 of the EU GDP Guidlines requires a written training programme. Read more 27-10-2021
EMA inicia avaliação de novo medicamento para a COVID-19 A 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 26-10-2021
CMDh Best Practice Guidance on Multilingual Packaging Read more 22-10-2021
New Limits for Heavy Metals in Food Supplements The 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 21-10-2021
Change Control for Computerised Systems Change 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 20-10-2021
Implementation of the European Pharmacopoeia Supplement 10.7 – Notification for CEP holders Supplement 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 19-10-2021
First-in-class medicine to treat aggressive form of breast cancer EMA 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 18-10-2021
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 15-10-2021
New Limits for Heavy Metals in Food Supplements The 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 13-10-2021
EMA receives application for marketing authorisation for Ronapreve (casirivimab / imdevimab) for treatment and prevention of COVID-19 EMA has started evaluating an application for marketing authorisation for the monoclonal antibody combination Ronapreve (casirivimab / imdevimab). The applicant is Roche Registration GmbH. Read more 12-10-2021
ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk This 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 08-10-2021
The ICH M7(R2) draft Guideline and Addendum reaches Step 2 of the ICH process The 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 07-10-2021
EU: further Extension of GMP and GDP Certificates The 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 06-10-2021
EMA starts review of meningioma risk with nomegestrol- and chlormadinone-containing medicines EMA 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 04-10-2021
Transatlantic Taskforce continues international fight against antimicrobial resistance The 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 01-10-2021
Risk of the presence of mutagenic azido impurities in losartan active substance In 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 30-09-2021
New General Ph. Eur. Chapter 2.1.7 Balances for Analytical Purposes In 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 29-09-2021
EMA evaluating data on booster dose of COVID-19 vaccine Spikevax EMA 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 28-09-2021
Good manufacturing practice Good 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 22-09-2021
EMA regular press briefing on COVID-19 The European Medicines Agency (EMA) is holding a fortnightly press briefing to provide an update on EMA's COVID-19 activities. Read more 21-09-2021
Nova edição do Boletim de Farmacovigilância Já está disponível a nova edição do Boletim de Farmacovigilância, Volume 25, n.º 8 de agosto de 2021. Read more 20-09-2021
COVID-19 vaccines and medicines: updates for September 2021 Recent 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 16-09-2021
Consultation on Amendments on Pharmacovigilance Activities A 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 15-09-2021
Deliberação n.º 956/2021 Cria no INFARMED, na dependência da Direção de Avaliação de Tecnologias de Saúde, a Unidade de Gestão da Avaliação e Acesso de Medicamentos Read more 14-09-2021
Deliberação n.º 946/2021 Alteração do Regulamento das Boas Práticas de distribuição por grosso de medicamentos de uso humano. Read more 13-09-2021
Increase in manufacturing capacity for COVID-19 vaccine from BioNTech/Pfizer EMA’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 10-09-2021
Final EMA Guideline: Quality Requirements for Combination Products Following 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 09-09-2021
ICH publishes Guideline Q13 on Continuous Production End 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 08-09-2021
Comunicado da Agência Europeia de Medicamentos: avaliação de pedido de utilização de dose de reforço da vacina Comirnaty A 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 07-09-2021
ECDC and EMA highlight considerations for additional and booster doses of COVID-19 vaccines Based 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 02-09-2021
EMA and FDA update Principles for Parallel Scientific Advice in the Marketing Authorization Process Scientific 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 01-09-2021
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 26-08-2021
Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech / Pfizer and Moderna EMA’s human medicines committee (CHMP) has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the EU. Read more 25-08-2021
FDA Approves First COVID-19 Vaccine Approval Signifies Key Achievement for Public Health Read more 24-08-2021
First monoclonal antibody treatment for COVID-19 approved for use in the UK The 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 20-08-2021
Audit Trail-Deviations in the course of Inspections Klaus 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 18-08-2021
EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19 EMA 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 17-08-2021
Northern Ireland: EU continues to look for Solutions - with interesting Forms of Documents Have 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 10-08-2021
Human medicines highlights - August 2021 Read more 06-08-2021
Comunicação conjunta EMA e ECDC sobre COVID-19: EMA e ECDC recomendam vacinação em todos os cidadãos elegíveis No 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 05-08-2021
Boas Práticas de Distribuição e Farmacovigilância Foram 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 04-08-2021
Sistema europeu de ensaios clínicos lançado em janeiro A 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 03-08-2021
Parecer sobre vacinação universal de pessoas entre os 12 e 15 anos A 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 30-07-2021
Novo serviço de alertas de tecnologias de saúde Desenvolvido 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 28-07-2021
Relatório de Farmacovigilância: monitorização da segurança das vacinas contra a COVID-19 em Portugal Read more 27-07-2021
Aviso de indisponibilidade de aplicações Informa-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 23-07-2021
Updated Templates for Reporting Nitrosamine Contamination to Regulatory Authorities Within 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 21-07-2021
EMA starts evaluating the use of Kineret in adult COVID-19 patients at increased risk of severe respiratory failure EMA 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 20-07-2021
International regulators work towards alignment on development and authorisation of second-generation COVID-19 vaccines Regulatory 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 19-07-2021
EMA and ECDC update on COVID-19 Vaccination 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 15-07-2021
Q&A Document on Nitrosamine Impurities Updated At 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 14-07-2021
Comirnaty e Spikevax: possível ligação a casos muito raros de miocardite e pericardite A 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 12-07-2021
Brexit: EU defines possible Solutions for Northern Ireland The 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 07-07-2021
Pharmeuropa 33.3 just released All 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 05-07-2021
Nitrosamine impurities The 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 02-07-2021
Novo Regulamento dos Dispositivos Médicos: ficha informativa para mandatários, importadores e distribuidores Consulte a infografia. Read more 30-06-2021
EMA publishes Q&A Document about Parallel Distribution Parallel 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 29-06-2021
First cell-based gene therapy to treat adult patients with multiple myeloma EMA 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 28-06-2021
Aplicação do Regulamento dos Dispositivos Médicos (RDM) na parte que se refere à investigação clínica de dispositivos O 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 25-06-2021
Novo Regulamento dos Dispositivos Médicos: ficha informativa para fabricantes Consulte a infografia. Read more 23-06-2021
Novo Regulamento dos Dispositivos Médicos: modelo para a implementação, passo a passo Consulte o guia passo a passo. Read more 17-06-2021
Ph. Eur. General Notices Chapter - New Structure and Content The European Pharmacopoeia (Ph. Eur.) Commission adopted a revised version of Ph. Eur. chapter 1. General Notices to provide greater clarity for users. Read more 16-06-2021
COVID-19 vaccines: update on ongoing evaluation of myocarditis and pericarditis EMA’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 14-06-2021
International regulators and WHO address need to boost COVID-19 vaccine confidence The 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 11-06-2021
Novo Regulamento dos Dispositivos Médicos: novas características Read more 09-06-2021
EMA raises awareness of clinical care recommendations to manage suspected thrombosis with thrombocytopenia syndrome EMA’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 08-06-2021
Relatório: Vacinas para a COVID-19 - Reações adversas em Portugal Read more 07-06-2021
Novo Regulamento dos Dispositivos Médicos: está preparado? Consulte a infografia com o calendário de transição das diretivas. Read more 04-06-2021
The GMP Requirements for Supplier Qualification Supplier Qualification is more than auditing. Supplier qualification can be seen as a risk assessment tool. But what are the exact requirements? Read more 02-06-2021
Questions & Answers on Good Distribution Practices (GDP) - Part 4 In 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 01-06-2021
First COVID-19 vaccine approved for children aged 12 to 15 in EU EMA’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 31-05-2021
Insufficient data on use of inhaled corticosteroids to treat COVID-19 EMA’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 28-05-2021
Comunicado de Imprensa - Novo Regulamento Europeu dos Dispositivos Médicos O 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 27-05-2021
APIC: Update of the Template for Potential Nitrosamine Contaminations The 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 26-05-2021
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 25-05-2021
First gene therapy to treat children with rare inherited neurological disease EMA 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 24-05-2021
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) Read more 21-05-2021
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 19-05-2021
Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices Read more 18-05-2021
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 13-05-2021
MHRA establishes own GMDP Database EudraGMDP 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 12-05-2021
Revised monograph Water for injections published for public comment in Pharmeuropa The 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 11-05-2021
Vacinas para a COVID-19: Relatório sobre reações adversas em Portugal O 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 10-05-2021
International regulators and WHO call for wider public access to clinical data The 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 07-05-2021
Revision of the PIC/S Guidelines for ATMPs and Biological Medicinal Products Especially 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 06-05-2021
EMA starts rolling review of COVID-19 Vaccine (Vero Cell) Inactivated EMA’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 05-05-2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15 EMA 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 04-05-2021
A new collaboration between SNOMED International and ICH promotes seamless data exchange in support of public health SNOMED International and ICH are announcing the release of important new maps between global medical terminologies SNOMED CT and MedDRA. Read more 30-04-2021
Factsheet for Class I - Medical Devices Read more 29-04-2021
Unidade de Farmacovigilância de Braga inicia atividades O 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 28-04-2021
Questions & Answers on Good Distribution Practices (GDP) - Part 3 In 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 27-04-2021
Banco Farmacêutico apela à doação de medicamentos Realiza-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 26-04-2021
COVID-19 Vaccine Janssen: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets At 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 21-04-2021
The Draft Principles of ICH E6 Good Clinical Practice (GCP) now available The 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 20-04-2021
EMA starts review of VIR-7831 for treating patients with COVID-19 EMA 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 16-04-2021
COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots with low platelets continues As 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 15-04-2021
Vaxzevria (previously COVID-19 Vaccine AstraZeneca): link between the vaccine and the occurrence of thrombosis in combination with thrombocytopenia Read more 13-04-2021
Pharmeuropa 33.2 just released All 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 09-04-2021
AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets EMA’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 08-04-2021
EMA: Revision of Q&A Documents regarding the Centralised Procedure Again, 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 07-04-2021
AstraZeneca COVID-19 vaccine: review of very rare cases of unusual blood clots continues EMA’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 01-04-2021
Rapid Revision and Implementation of Pharmacopoeial Monographs Concerning 5 Sartan Preparations Following 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 31-03-2021
Increase in vaccine manufacturing capacity and supply for COVID-19 vaccines from AstraZeneca, BioNTech/Pfizer and Moderna EMA’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 29-03-2021
COVID-19 Vaccine AstraZeneca – Update on ongoing evaluation of blood clot cases Last 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 26-03-2021
Brexit: Pharmacovigilance Requirements for UK MAHs Following the Brexit, the MHRA posted an updated guidance to become familiar with the pharmacovigilance requirements for UK marketing authorization holders (MAHs). Read more 24-03-2021
EMA advises against use of ivermectin for the prevention or treatment of COVID-19 outside randomised clinical trials EMA 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 23-03-2021
COVID-19 Vaccine AstraZeneca: benefits still outweigh the risks despite possible link to rare blood clots with low blood platelets EMA’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 19-03-2021
Coronavirus: Commission proposes a Digital Green Certificate Read more 18-03-2021
Investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events continues EMA’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 17-03-2021
EMA’s safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further update Several 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 16-03-2021
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 AstraZeneca A 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 15-03-2021
EMA recommends COVID-19 Vaccine Janssen for authorisation in the EU Read more 12-03-2021
Vacina contra a COVID-19 AstraZeneca: resultados preliminares não sugerem problema específico com o lote usado na Áustria Na 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 11-03-2021
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 09-03-2021
Suspensão da AIM de medicamentos contendo ranitidina Conforme 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 08-03-2021
Practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DCP Read more 05-03-2021
EMA starts rolling review of the Sputnik V COVID-19 vaccine EMA’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 04-03-2021
EMA Guidance on Adjusting Vaccines to COVID-19 Variants Currently, 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 03-03-2021
First oral treatment for spinal muscular atrophy (SMA) recommended for approval EMA 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 01-03-2021
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines Regulators 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 26-02-2021
EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19 EMA’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 25-02-2021
Brexit: Pharmacovigilance Requirements for UK MAHs Following the Brexit, the MHRA posted an updated guidance to become familiar with the pharmacovigilance requirements for UK marketing authorization holders (MAHs). Read more 24-02-2021
EMA starts evaluating use of Veklury in COVID-19 patients not requiring supplemental oxygen EMA 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 23-02-2021
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 Read more 22-02-2021
Coronavirus: preparing Europe for the increased threat of variants Read more 18-02-2021
Brexit Guideline from CMDh updated The 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 17-02-2021
EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV) Read more 12-02-2021
EMA preparing guidance to tackle COVID-19 variants Read more 11-02-2021
COVID-19 vaccine safety update for COVID-19 Vaccine Moderna: February 2021 Read more 08-02-2021
Modern Vaccines and Platform Technologies - Explained in an Understandable Way In the current situation, we receive a variety of questions about the current vaccine development, vaccine types, licensure and more. Read more 05-02-2021
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 04-02-2021
New EU Commission Brexit Notice on Medicinal Products The 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 03-02-2021
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 02-02-2021
EMA recommends COVID-19 Vaccine AstraZeneca for authorisation in the EU EMA 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 01-02-2021
First COVID-19 vaccine safety update published Today 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 29-01-2021
Rastreabilidade de stocks de medicamentos para COVID-19 Em 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 26-01-2021
COVID-19 and vaccines: Equitable access to vaccination must be ensured How 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 25-01-2021
Public-health advice during COVID-19 pandemic The 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 21-01-2021
Global regulators highlight key role of healthcare professionals in fostering confidence in COVID-19 vaccines EMA 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 20-01-2021
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 15-01-2021
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 13-01-2021
EMA receives application for conditional marketing authorisation of COVID-19 Vaccine AstraZeneca EMA 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 12-01-2021
Extra dose from vials of Comirnaty COVID-19 vaccine EMA’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 11-01-2021
EMA recommends COVID-19 Vaccine Moderna for authorisation in the EU EMA 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 07-01-2021
Brexit: the United Kingdom's withdrawal from the European Union The 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 04-01-2021
EMA organises a second public meeting about the new COVID-19 vaccines EMA 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 23-12-2020
European Commission authorises first safe and effective vaccine against COVID-19 Read more 22-12-2020
EMA Management Board: highlights of December 2020 meeting The 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 21-12-2020
Update on assessment of marketing authorisation application for Moderna’s mRNA-1273 COVID-19 vaccine Over 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 18-12-2020
Update on assessment of the BioNTech and Pfizer BNT162b2 vaccine marketing authorisation application EMA’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 16-12-2020
Comissão Europeia disponibiliza Q&A sobre vacinas COVID-19 A 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 15-12-2020
COVID-19 vaccines: studies for approval The 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 14-12-2020
infoDM em vídeo: nova ferramenta de pesquisa pública de dispositivos médicos Já 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 10-12-2020
Estratégia conjunta prepara futuro da rede de agências reguladoras de medicamentos da UE até 2025 Como 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 09-12-2020
EMA publica orientações sobre flexibilização quanto à informação do medicamento (Folheto Informativo e Rotulagem) para as vacinas contra a COVID-19 No 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 07-12-2020
Coronavirus: Commission presents “Staying safe from COVID-19 during winter” strategy Read more 03-12-2020
EMA receives application for conditional marketing authorisation of COVID-19 mRNA vaccine BNT162b2 EMA 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 02-12-2020
EMA - Public Meeting on COVID-19 Vaccines No 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 25-11-2020
Update on remdesivir - EMA will evaluate new data from Solidarity trial EMA 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 23-11-2020
EMA publica documento sobre critérios de desenvolvimento e avaliação clínica das vacinas contra a COVID-19 No 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 20-11-2020
Coronavirus: Commission steps up actions on testing with a recommendation on rapid antigen tests and support to increase testing capacity Read more 19-11-2020
Antimicrobial resistance The 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 18-11-2020
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 17-11-2020
Nitrosamines: EMA aligns recommendations for sartans with those for other medicines EMA’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 16-11-2020
COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs The 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 13-11-2020
Consulte a nova infografia sobre o SIDM Sistema de Informação para Dispositivos Médicos (SIDM), desenvolvido no âmbito do programa SIMPLEX, foi lançado a 2 de novembro de 2020. Read more 10-11-2020
International regulators and WHO join forces to address COVID-19 challenges Read more 09-11-2020
Novo Sistema de Informação para Dispositivos Médicos (SIDM): assista ao vídeo O 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 06-11-2020
Novo sistema de informação para dispositivos médicos O 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 05-11-2020
Labelling and Packaging Flexibilities for Covid-19 Vaccines The 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 04-11-2020
Extra transparency measures for COVID-19 vaccines and therapeutics The 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 02-11-2020
Pharmacovigilance Legislation Read more 28-10-2020
PRAC recommendations on safety signals Each 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 27-10-2020
Strengthening global collaboration on COVID-19 real-world evidence and observational studies Read more 26-10-2020
Novo Sistema de Informação para Dispositivos Médicos (SIDM) Read more 20-10-2020
Nitrosamine impurities Read more 19-10-2020
EMA starts second rolling review of a COVID-19 vaccine EMA’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 07-10-2020
EU regulators fully uphold transparency and independence standards for COVID-19 treatments and vaccines The 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 06-10-2020
EMA starts first rolling review of a COVID-19 vaccine in the EU EMA’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 02-10-2020
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 oxigénio O 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 01-10-2020
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 30-09-2020
PRAC recommendations on safety signals Each 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 29-09-2020
EFPIA statement on the European Regulatory Network Strategy to 2025 EFPIA 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 15-09-2020
AstraZeneca Resumes Phase 3 COVID-19 Vaccine Trial in UK AstraZeneca 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 14-09-2020
Comunicado de Imprensa - Suspensão momentânea de vacina para COVID-19 De 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 10-09-2020
Brexit: How to import Medicines into UK The 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 09-09-2020
Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) from 1 January 2021 Pharmacovigilance system requirements from 1 January 2021 Read more 07-09-2020
COVID-19: What's new Read more 03-09-2020
EU: Checklist for Brexit Preparation The European Commission has published a 'Brexit Readiness Checklist' for companies doing business with the UK. Read more 02-09-2020
PIC/S publishes Q&A document on Health Based Exposure Limits and Cross-Contamination In 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 26-08-2020
GDP Monograph for Active Substances: Interactive PDF now available In 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 25-08-2020
COVID-19: What's new Read more 21-08-2020
Coronavirus: Commission approves funding for training of healthcare professionals in intensive care skills Read more 20-08-2020
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 19-08-2020
Nitrosamines risk assessment: update for CEP holders In 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 17-08-2020
Estratégia da Rede de Agências Europeias de Medicamentos em consulta pública A 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 14-08-2020
Evaluation of the medicines for rare diseases and children legislation On 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 12-08-2020
INFORMATION ON NITROSAMINES FOR MARKETING AUTHORISATION HOLDERS 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 11-08-2020
The E2B(R3) User Guide v1.1 Available Now on the ICH Website The 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 10-08-2020
FIP atualiza relatório sobre vacinação nas farmácias A 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 07-08-2020
Brexit: Sponsors Need to Establish an EU-QP Since 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 06-08-2020
The ICH S11 introductory training presentation available now on the ICH website The 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 04-08-2020
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UK Group Receives CE Mark for COVID-19 Rapid Antibody Test UK diagnostics company Abingdon Health has received a CE Mark for a COVID-19 antibody test that delivers results in 20 minutes. Read more 31-07-2020
Guidance for medicine developers and companies on COVID-19 The 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 28-07-2020
EMA starts review of dexamethasone for treating adults with COVID-19 requiring respiratory support EMA 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 27-07-2020
CHMP's Assessment Report on Nitrosamines published On 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 23-07-2020
Pharmacovigilance Audits and Inspections during COVID-19 The 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 21-07-2020
Covid-19: Handling of Marketing Authorisations The 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 16-07-2020
Regulatory Authorities worldwide work more closely together because of COVID-19 The 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 15-07-2020
Infarmed e restantes agências de medicamentos europeias juntas no combate à COVID-19 Os 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 13-07-2020
EMA finalises opinion on presence of nitrosamines in medicines EMA’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 10-07-2020
Procedural guidance during COVID-19 pandemic Read more 09-07-2020
Distant Assessment leads to GMP Non-Compliance Report Many 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 08-07-2020
PRAC recommendations on signals adopted at the 8-11 June 2020 PRAC meeting Read more 07-07-2020
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 03-07-2020
Impact of COVID-19 on EudraVigilance Reporting and Labeling The 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 02-07-2020
New GDP Monograph for Active Substances published 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. Read more 01-07-2020
First COVID-19 treatment recommended for EU authorisation EMA’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 26-06-2020
Recommendations on medication errors In 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 25-06-2020
Nitrosamine impurities In 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 24-06-2020
European Commission, EMA and FDA agree new priorities to strengthen their collaboration on medicines Senior 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 23-06-2020
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 19-06-2020
International regulators stress value of safe and effective vaccines EMA 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 18-06-2020
Remote GCP Inspections The 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 17-06-2020
Follow-up activities after Pharmacovigilance Inspections EMA´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 16-06-2020
EDQM provides COVID-19 vaccine developers with free access to quality standards applicable in Europe The 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 08-06-2020
EU Member States report illegal and ineffective disinfectants Several 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 05-06-2020
Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis Read more 04-06-2020
Derogation for Process Validation due to Covid-19 Europe 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 03-06-2020
COVID-19: reminder of the risks of chloroquine and hydroxychloroquine EMA 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 01-06-2020
European medicines regulatory network fully mobilised in fight against COVID-19 The 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 29-05-2020
Prospective dialogue between developers and regulators makes for better evidence generation EMA, 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 28-05-2020
EMA commissions independent research to prepare for real-world monitoring of COVID-19 vaccines EMA 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 27-05-2020
Resposta à COVID-19 aprovada em Assembleia Mundial da Saúde A 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 25-05-2020
Global regulators commit to cooperate on observational research in the context of COVID-19 Regulators 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 21-05-2020
What Marketing Authorisation Holders need to know now about their Registrations On 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 20-05-2020
Update of EU recommendations for 2020/2021 seasonal flu vaccine composition EMA 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 18-05-2020
Máscaras: normas aplicáveis e tipologia Com 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 15-05-2020
USP´s Quality Considerations for Medical Cannabis Authors 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 13-05-2020
EMA recommends expanding remdesivir compassionate use to patients not on mechanical ventilation EMA’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 12-05-2020
Global regulators work towards alignment on policy approaches and regulatory flexibility during COVID-19 In 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 06-05-2020
Infarmed lança infografias alertando para a importância da notificação de reações adversas em doentes com COVID-19 O 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 05-05-2020
EMA starts rolling review of remdesivir for COVID-19 EMA’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 04-05-2020
New EU/EMA planned Actions in the Context of the COVID-19 Pandemic The European Medicines Agency EMA has published three press releases on current EU/EMA activities in the context of the COVID-19 pandemic. Read more 29-04-2020
Guidance for medicine developers and companies on COVID-19 The 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 20-04-2020
Avaliação da presença de nitrosaminas - Adiamento do prazo para submissão e perguntas frequentes Conforme 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 15-04-2020
EMA establishes task force to take quick and coordinated regulatory action related to COVID-19 medicines As 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 13-04-2020
Nova edição da newsletter com resumo da informação da área COVID-19 Está disponível nova edição da newsletter com o resumo da informação mais recentemente publicada na área COVID-19. Read more 09-04-2020
Ph. Eur. launches a public consultation on a new general chapter for the analysis of N-Nitrosamines The 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 08-04-2020
EU authorities agree new measures to support availability of medicines used in the COVID-19 pandemic The 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 07-04-2020
Commission postpones application of the Medical Devices Regulation to prioritise the fight against coronavirus Read more 06-04-2020
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 02-04-2020
Regulatory guidance for medical devices Check 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 01-04-2020
Information package for certificates of medicinal products issued by the European Medicines Agency Read more 31-03-2020
European Commission Calls for One Year Delay of Medical Device Regulation Read more 30-03-2020
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 27-03-2020
Information on nitrosamines for marketing authorisation holders Read more 26-03-2020
EU GMP Annex 21 finally published On 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 25-03-2020
Código de Conduta nos circuitos de distribuição e venda de produtos fitofarmacêuticos A 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 24-03-2020
Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic The 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 23-03-2020
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure Read more 20-03-2020
Notice to stakeholders ´Withdrawal of the United Kingdom and EU rules for medicinal products for human and veterinary use" Read more 19-03-2020
CMDh Guidance Document on the Numbering System for the Procedures for Mutual Recognition and Decentralised Read more 17-03-2020
Rastreabilidade de stocks de medicamentos para COVID-19 - formato de reporte Na 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 16-03-2020
Clinical pharmacology and pharmacokinetics: questions and answers Read more 13-03-2020
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 ) Read more 12-03-2020
National recommendations for requests to act as RMS in DCPs Read more 11-03-2020
Questions and answers (version 17) - Safety features for medicinal products for human use Read more 10-03-2020
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 09-03-2020
EMA EudraVigilance Registration Manual Read more 05-03-2020
Update on nitrosamines in EU medicines EU and national authorities are continuing their work to prevent and manage the presence of nitrosamine impurities in EU medicines. Read more 04-03-2020
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 Read more 03-03-2020
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 02-03-2020
CMDh Best Practice Guide on Multilingual Packaging Read more 28-02-2020
QbD for TDS: FDA´s new draft guidance The FDA published a draft guideline "Transdermal and Topical Delivery Systems - Product Development and Quality Considerations". Read more 27-02-2020
Draft Annex 1: New Requirements for Lyophilization? Will the revised Annex 1 introduce new GMP requirements for lyophilized products? Read more 26-02-2020
FDA Revises Guidance on Electronic Drug Submissions The 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 24-02-2020
Second joint targeted stakeholders' consultation on the revision of Annex 1, on manufacturing of sterile medicinal products, of the PIC/S – EU GMP Guide Read more 21-02-2020
ICH S5(R3) reaches Step 4 of the ICH Process The 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 19-02-2020
Implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products Read more 18-02-2020
Post-Brexit UK to Overhaul Medical Device Authority The new legislation would empower the health department to impose monetary penalties as an alternative to criminal prosecution. Read more 17-02-2020
FDA Guidance Seeks to Speed Reviews of Biosimilars for Fewer Conditions of Use As 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 14-02-2020
Formulário eletrónico para avaliação da presença de nitrosamina em medicamento Conforme 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 12-02-2020
New GMP Guidance for Marketing Authorisation Holders After 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 11-02-2020
UK Offers Grace Period for Sudden Notified Body Withdrawals Some 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 10-02-2020
UK Waves Goodbye to EU as Transition Period Begins The 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 07-02-2020
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 06-02-2020
EMA to support development of vaccines and treatments for novel coronavirus To 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 05-02-2020
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 04-02-2020
UK withdrawal from the EU on 31 January 2020 The 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 03-02-2020
Falta de medicamentos agrava-se na Europa O Grupo Farmacêutico da União Europeia (PGEU) está a acompanhar o fenómeno de escassez de medicamentos em vários países europeus. Read more 31-01-2020
Report on public consultation on the 'Electronic product information for human medicines in the European Union - draft key principles' Read more 30-01-2020
SCCS - Read the new factsheet: "The SCCS Guidance on the safety assessment of nanomaterials in cosmetics" Read more 29-01-2020
FDA Announces Plan for Electronic Orphan Drug Designation Submissions The FDA plans to allow sponsors to submit orphan drug designation requests electronically later this year. Read more 28-01-2020
Produtos fitofarmacêuticos - Classificação harmonizada de substâncias ativas A 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 27-01-2020
European Medicines Agency’s privacy statement for the EMA Account Management system Read more 24-01-2020
Choice of timetable for type II variations and worksharing applications Read more 23-01-2020
Procedural advice for orphan medicinal product designation: Guidance for sponsors Read more 22-01-2020
Detailed guide regarding the EudraVigilance data management activities by the European Medicines Agency Read more 21-01-2020
MedTech Europe Renews Alarm Over MDR Transition Time 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 20-01-2020
EMA/CHMP publishes new Q&A Document on Comparability Considerations for ATMPs The 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 17-01-2020
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 Read more 16-01-2020
Disponível webservice para notificação de faltas de medicamentos Conforme previsto no Regulamento de Gestão da Disponibilidade do Medicamento, o webservice para comunicação automática das faltas de medicamentos está disponível. Read more 15-01-2020
Ranitidine Can Generate NDMA Under Storage Conditions, Lab Says Ranitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Read more 14-01-2020
IRIS guide for Parallel Distribution applicants Read more 13-01-2020
Orientações europeias dirigidas a fabricantes de dispositivos médicos da classe I No 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 10-01-2020
Pharmeuropa 32.1 just released All 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 08-01-2020
Ranitidine Can Generate NDMA Under Storage Conditions, Lab Says Ranitidine can generate N-nitrosodimethylamine (NDMA) when stored at higher temperatures, a research laboratory has found, raising new safety concerns. Read more 06-01-2020
Canada Releases Final Guidance on Software as a Medical Device Health 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 03-01-2020
New symbols for medical device label now available on the ISO website In 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 02-01-2020
ISO Issues Risk Management Standard for Devices The International Organization for Standardization (ISO) has released a standard for device manufacturers for assessing and controlling potential medical device hazards. Read more 27-12-2019
Revisão Anual de Preços - 2020 Revisão Anual de Preços de Medicamentos Genéricos e Não Genéricos_2020 Read more 23-12-2019
Trump Administration takes historic steps to lower U.S. prescription drug prices President 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 19-12-2019
4-year overview of pharmacovigilance activities in the EU shows robust and effective medicines safety system A 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 18-12-2019
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure Read more 17-12-2019
Apply for a licence to market a medicine in the UK How to license a medicine for sale in the UK and Europe, including applications through national, centralised and decentralised procedures. Read more 16-12-2019
VICH GL58 stability testing of new veterinary drug substances and medicinal products in climatic zones III and IV - First version Read more 13-12-2019
Outcome of the 165th European Pharmacopoeia Commission During 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 12-12-2019
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 Read more 11-12-2019
EMA update on metformin diabetes medicines EMA 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 09-12-2019
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 06-12-2019
FDA Issues Guidance on Transdermal and Topical Drug Delivery Systems The 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 05-12-2019
European authorities working to avoid shortages of medicines due to Brexit – Questions and answers Read more 04-12-2019
ICH Q12 adopted The 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 03-12-2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 Novemver 2019 At 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 02-12-2019
Questions and answers on “Information on nitrosamines for marketing authorisation holders” Read more 29-11-2019
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 brexit A 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 28-11-2019
Final Guideline on CCP for ATMPs published In 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 27-11-2019
Falsified Medicines: New EU Aide Memoire for GDP The 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 26-11-2019
Novo portal e novo protocolo de cedência de informação A 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 25-11-2019
Information for the package leaflet regarding ethanol used as an excipient in medicinal products for human use Read more 22-11-2019
Report from the meeting held on 12-14 November 2019 Read more 21-11-2019
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 20-11-2019
Commission report on the national and European Medicines Agency experience regarding the list of medicines for human use subject to additional monitoring Read more 19-11-2019
Companies need to improve communication of hazardous substances in products A 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 18-11-2019
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). Read more 15-11-2019
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. Read more 14-11-2019
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. Read more 13-11-2019
‘Regulatory science to 2025’: live broadcast of post-consultation workshop Read more 12-11-2019
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. Read more 11-11-2019
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. Read more 08-11-2019
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. Read more 07-11-2019
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? Read more 06-11-2019
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. Read more 05-11-2019
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. Read more 04-11-2019
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. Read more 31-10-2019
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. Read more 30-10-2019
PRAC recommendations on signals adopted at the 30 September-3 October 2019 PRAC meeting Read more 29-10-2019
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 28-10-2019
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 25-10-2019
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019 Read more 18-10-2019
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. Read more 17-10-2019
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. Read more 16-10-2019
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. Read more 15-10-2019
Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 October 2019 Read more 14-10-2019
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. Read more 11-10-2019
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. Read more 08-10-2019
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. Read more 07-10-2019
Four-week limit for use of high-strength estradiol creams Read more 04-10-2019
FDA Cautions on Use of ‘Bayesian’ Statistics in Complex Trials Using Bayesian methods “can increase the chance of erroneous conclusions,” the agency says. Read more 03-10-2019
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. Read more 02-10-2019
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". Read more 01-10-2019
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. Read more 30-09-2019
Change of name of liposomal medicines at high risk of medication errors Read more 27-09-2019
Information on nitrosamines for marketing authorisation holders Read more 26-09-2019
UPDATE - Q&As on Variations Read more 25-09-2019
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. Read more 24-09-2019
EMA’s work on new veterinary regulation advances Read more 23-09-2019
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. Read more 20-09-2019
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. Read more 19-09-2019
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. Read more 18-09-2019
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. Read more 17-09-2019
EMA to review ranitidine medicines following detection of NDMA Read more 16-09-2019
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. Read more 13-09-2019
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). Read more 12-09-2019
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. Read more 11-09-2019
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 10-09-2019
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. Read more 09-09-2019
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. Read more 06-09-2019
Orchestra BioMed Receives CE Mark for Implantable Hypertension Treatment The principal investigator said the device has potential as a primary treatment for hypertension. Read more 05-09-2019
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. Read more 04-09-2019
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. Read more 03-09-2019
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. Read more 02-09-2019
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. Read more 30-08-2019
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. Read more 29-08-2019
White House Highlights ‘Red Flags’ for Illicit Fentanyl The manufacturing advisory identifies the various stages of illegal fentanyl manufacturing and distribution. Read more 28-08-2019
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. Read more 27-08-2019
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. Read more 26-08-2019
New measures to avoid potentially fatal dosing errors with methotrexate for inflammatory diseases Read more 23-08-2019
Questions and answers on the exemption from batch controls carried out on ATMPs imported into the European Union from a third country Read more 22-08-2019
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). Read more 21-08-2019
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. Read more 20-08-2019
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. Read more 19-08-2019
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 Read more 16-08-2019
EMA closed 15 August 2019 Read more 14-08-2019
How to detect Falsified Medicines Falsified medicines repeatedly occur in the supply chain. The MHRA now provides information on how to detect them. Read more 13-08-2019
What’s new in pharmacovigilance - QPPV Update - Issue 1 - 2019 Read more 12-08-2019
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. Read more 09-08-2019
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. Read more 08-08-2019
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. Read more 07-08-2019
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. Read more 06-08-2019
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”. Read more 05-08-2019
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. Read more 02-08-2019
Names of liposomal medicines to be changed to avoid medication errors Read more 01-08-2019
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. Read more 31-07-2019
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). Read more 30-07-2019
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 29-07-2019
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). Read more 26-07-2019
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. Read more 25-07-2019
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. Read more 24-07-2019
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. Read more 23-07-2019
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. Read more 22-07-2019
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. Read more 19-07-2019
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. Read more 18-07-2019
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. Read more 17-07-2019
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. Read more 16-07-2019
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. Read more 15-07-2019
EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers Read more 12-07-2019
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. Read more 11-07-2019
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. Read more 10-07-2019
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. Read more 09-07-2019
Creams, Gels & Pastes redefined A revised version of the Ph. Eur. Monograph Semi-solid preparations for cutaneous application has been published in Pharmeuropa. Read more 08-07-2019
Medicine shortages: EU network takes steps to improve reporting and communication Read more 05-07-2019
Call for all sponsors to publish clinical trial results in EU database Read more 04-07-2019
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. Read more 03-07-2019
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. Read more 02-07-2019
Product-information templates Compliance with QRD template v10.1 Read more 01-07-2019
QRD product-information annotated template (English) version 10.1 - highlighted Read more 28-06-2019
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. Read more 27-06-2019
Temporary interim limits for NMBA, DIPNA and EIPNA impurities in sartan blood pressure medicines Read more 26-06-2019
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. Read more 25-06-2019
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. Read more 24-06-2019
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. Read more 21-06-2019
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 19-06-2019
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. Read more 18-06-2019
Leuprorelin-containing depot medicinal products Leuprorelin , See "List of the medicines affected by the referral (Annex I)", Article 31 referrals, Procedure started Read more 17-06-2019
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. Read more 14-06-2019
Two additional countries to benefit from EU-US mutual recognition agreement for inspections Read more 12-06-2019
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 11-06-2019
EMA closed 10 June 2019 EMA is closed from 18:30 on Friday 7 June until 7:30 on Tuesday 11 June 2019. Read more 07-06-2019
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. Read more 06-06-2019
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. Read more 05-06-2019
Consultation on draft guideline on quality requirements for medical devices in combination products Read more 04-06-2019
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. Read more 03-06-2019
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. Read more 31-05-2019
Withdrawal of marketing authorisations for fenspiride medicines Read more 30-05-2019
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. Read more 29-05-2019
EMA closed 30-31 May 2019 Read more 28-05-2019
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. Read more 27-05-2019
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. Read more 24-05-2019
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. Read more 23-05-2019
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”. Read more 22-05-2019
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. Read more 21-05-2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13-16 May 2019 Read more 20-05-2019
FDA Lays Out Weight of Evidence Guidelines for Fetal Toxicity in Oncology The weight of evidence could include a review of existing literature. Read more 17-05-2019
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. Read more 16-05-2019
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). Read more 15-05-2019
Implementação das obrigações legais no que respeita aos dispositivos de segurança Read more 14-05-2019
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. Read more 13-05-2019
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. Read more 10-05-2019
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. Read more 09-05-2019
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 08-05-2019
European Medicines Agency closed 9 May 2019 Read more 07-05-2019
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. Read more 06-05-2019
Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices Read more 03-05-2019
Two additional countries to benefit from EU-US mutual recognition agreement for inspections Read more 02-05-2019
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? Read more 30-04-2019
European Medicines Agency closed 1 May 2019 Read more 29-04-2019
European Parliament Evens Scales for Generics Makers With New SPC Waivers The European Commission says the reform will “remove a major competitive disadvantage.” Read more 26-04-2019
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. Read more 24-04-2019
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 23-04-2019
Indisponibilidade Por motivos de ordem técnica, o site do Infarmed estará indisponível durante o dia 23 de abril (amanhã, 3ª feira). Read more 22-04-2019
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). Read more 18-04-2019
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. Read more 17-04-2019
EMA closed 18-22 April 2019 Read more 16-04-2019
Practical guidance for procedures related to Brexit for medicinal products for human and veterinary use within the framework of the centralised procedure Read more 15-04-2019
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 April 2019 Read more 12-04-2019
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. Read more 11-04-2019
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. Read more 10-04-2019
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. Read more 09-04-2019
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. Read more 08-04-2019
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. Read more 05-04-2019
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. Read more 04-04-2019
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. Read more 03-04-2019
Regulatory information – 1.7% increase of fees from 1 April 2019 Read more 02-04-2019
Draft ICH guideline E19 on optimisation of safety data collection - Step 2b Read more 01-04-2019
20 years of sampling and testing of centrally authorised products: 1998 – 2017 Read more 29-03-2019
New EudraVigilance system improves reporting of side effects and detection of safety signals Read more 28-03-2019
Questions & answers: EU actions to prevent medicine shortages due to Brexit Read more 27-03-2019
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. Read more 26-03-2019
EMA Management Board: highlights of March 2019 meeting Read more 25-03-2019
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. Read more 22-03-2019
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. Read more 21-03-2019
GMP for Cannabis - What is required? More and more countries allow cannabis for medicinal purposes - But what are the regulatory requirements? Read more 20-03-2019
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? Read more 19-03-2019
Medicamentos veterinários: Atualização Brexit Pedidos de isenção por tempo limitado para continuar o teste de controlo de lote no Reino Unido após a saída do Reino Unido da União Europeia.

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