Regulatory News

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

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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)

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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

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• 22-02-2021

Coronavirus: preparing Europe for the increased threat of variants

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• 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)

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• 12-02-2021

EMA preparing guidance to tackle COVID-19 variants

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• 11-02-2021

COVID-19 vaccine safety update for COVID-19 Vaccine Moderna: February 2021

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• 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

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• 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

Leuprorelin-containing depot medicinal products.

Leuprorelin , Daronda,Depo-Eligard,Eligard,Eligard Depot,Eligard Mensua,Eligard Semestral,Eligard Trimestral,Elityran 1 Month Depot (Dps),Elityran 3 Month Depot (Dps),Enanton Depot Dual,Enanton Depot Set,Enantone,Enantone L.P,Enantone Lp,Enantone Monats-Depot,Ginecrin Depot,Klebrocid 3-Monats-Depot,Klebrocid Depot Zweikammerspritze,Leptoprol,Lerin,Leugon,Leuprex 3,Leuprol,Leuprolin Ratiopharm,Leuprone 1-Monatsdepot,Leuprone 3-Monatsdepot,Leuprorelin 1-Month Depot Gp-Pharm,Leuprorelin Hexal,Leuprorelin Sandoz,Leuprorelina Gp-Pharm,Leupro-Sandoz 1-Monats-Depot,Leupro-Sandoz 3-Monats-Depot,Leuprorelina Trimestral Sandoz,Leuprostin,Leuproreline Sandoz,Lucrin,Lucrin Depot,Lucrin Pds Depot,Lucrin Pds Depot 1 Maand,Lucrin Pds Depot 3 Maanden,Lucrin Pds Depot 6 Maanden,Lupron Depo,Lutrate 1 Month Depot,Lutrate 3 Month Depot,Lutrate Depo,Lutrate Depot,Lutrate Depot Trimestral,Politrate,Politrate Politrate Depot,Procren Depot,Procren Depot Pds,Procrin Mensual,Procrin Semestral,Procrin Trimestral,Prostap 3 Dcs,Prostap 6 Dcs,Prostap Sr Dcs,Prostaplant,Sixantone,Trenantone,Trenantone-Gyn,Zeulide,Елигард,Лутрат Депо, Article 31 referrals, CMDh final position, 24/06/2020, 31/07/2020 Read more

• 03-08-2020

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

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• 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

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• 31-03-2020

European Commission Calls for One Year Delay of Medical Device Regulation

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• 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

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• 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

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• 20-03-2020

Notice to stakeholders ´Withdrawal of the United Kingdom and EU rules for medicinal products for human and veterinary use"

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• 19-03-2020

CMDh Guidance Document on the Numbering System for the Procedures for Mutual Recognition and Decentralised

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• 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

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• 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 )

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• 12-03-2020

National recommendations for requests to act as RMS in DCPs

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• 11-03-2020

Questions and answers (version 17) - Safety features for medicinal products for human use

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• 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

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• 09-03-2020

EMA EudraVigilance Registration Manual

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• 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

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• 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

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• 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

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• 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

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• 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'

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• 30-01-2020

SCCS - Read the new factsheet: "The SCCS Guidance on the safety assessment of nanomaterials in cosmetics"

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• 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

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• 24-01-2020

Choice of timetable for type II variations and worksharing applications

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• 23-01-2020

Procedural advice for orphan medicinal product designation: Guidance for sponsors

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• 22-01-2020

Detailed guide regarding the EudraVigilance data management activities by the European Medicines Agency

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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

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• 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”

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• 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

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• 22-11-2019

Report from the meeting held on 12-14 November 2019

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• 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

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• 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).

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• 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.

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• 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.

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• 13-11-2019

‘Regulatory science to 2025’: live broadcast of post-consultation workshop

 

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• 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.

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• 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.

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• 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.

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• 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?

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• 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.

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• 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.

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• 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.

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• 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.

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• 30-10-2019

PRAC recommendations on signals adopted at the 30 September-3 October 2019 PRAC meeting

 

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• 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

 

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• 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)

 

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• 25-10-2019

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 2019

 

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• 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.

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• 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.

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• 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.

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• 15-10-2019

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 8-10 October 2019

 

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• 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.

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• 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.

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• 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.

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• 07-10-2019

Four-week limit for use of high-strength estradiol creams

 

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• 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.

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• 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.

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• 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".

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• 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.

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• 30-09-2019

Change of name of liposomal medicines at high risk of medication errors

 

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• 27-09-2019

Information on nitrosamines for marketing authorisation holders

 

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• 26-09-2019

UPDATE - Q&As on Variations

 

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• 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.

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• 24-09-2019

EMA’s work on new veterinary regulation advances

 

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• 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.

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• 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.

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• 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.

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• 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.

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• 17-09-2019

EMA to review ranitidine medicines following detection of NDMA

 

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• 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.

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• 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).

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• 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.

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• 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

 

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• 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.

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• 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.

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• 06-09-2019