Representatives of Patients’ Associations and Clinicians: Call for expressions of interest is open for the EMA Committee for Advanced Therapies. The Commission is launching a selection procedure to appoint the Representatives of Patients’ Associations and...
The EMA published its last version of the post-authorisation procedural advice for users of the centralised procedure. This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures....
The EMA issued its fourth version of the guidance On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services. This document is intended to provide guidance and information for stakeholders supporting the implementation...
The European Medicines Agency (EMA) publishes the outcomes of final study results of imposed non-interventional post-authorisation safety studies (PASS) for medicines authorised in the European Union (EU). The rules on submitting results for imposed non-interventional...
Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework. Read the news from Medicines and Healthcare products Regulatory Agency published on 30 August 2024.
The Commission is launching a selection procedure to appoint the Representatives of Patients’ Associations and Clinicians in the Committee for Advanced Therapies of the European Medicines Agency. Read the news announcement published by EC Directorate-General for...
The EMA updated its EudraVigilance support guide – Guidance document on the query support options offered by the EMA on EudraVigilance- and Pharmacovigilance-related queries. More information on EudraVigilance and EudraVigilance training and support on the...
The EMA recently updated its EudraVigilance support guide. More information on EudraVigilance and more EudraVigilance training and support.
“Le comité de pharmacovigilance (PRAC) de l’Agence européenne des médicaments (EMA) recommande la mise en place de mesures de réduction du risque pour les patients de sexe masculin traités par valproate ou ses dérivés en...
For all UK MAs, including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the marketing authorisation holder must have permanently and continuously at its disposal a...
