Europe – Codéine et ibuprofène (Antarene codeine) : cas d’abus/dépendance et mise en garde...
Le comité de pharmacovigilance (PRAC) de l’Agence européenne des médicaments (EMA) recommande de nouvelles mesures pour réduire les risques d’insuffisance respiratoire et de sepsis...
Europe – EU recommendations for 2023-2024 seasonal flu vaccine composition
EMA has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from...
Europe – EMA proposes waiving comparative efficacy studies for certain biosimilars
The European Medicines Agency (EMA) is proposing to waive comparative efficacy studies (CES) for biosimilars with a straightforward mechanism of action (MOA), such as...
UK – European Commission Decision Reliance Procedure (ECDRP) extension
The European Commission Decision Reliance Procedure (ECDRP) has been extended to 31 December 2023. From 1 January 2024 a new international recognition framework will be in...
Europe – New Quality Innovation Expert Group (QIG) supports medicine innovation
EMA has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of...
Europe – Global regulators strengthen efforts to ensure continuous availability of safe and high-quality...
On 20 July 2023, a virtual workshop was held to discuss progress made in the development of a PQ KMS. The workshop was jointly organised by...
Europe – EMA Q&A addresses submission of data elements for raw data pilot
The European Medicines Agency (EMA) this week issued a question-and-answer guidance to address sponsors’ questions on its pilot testing the review of raw clinical...
Europe – Precautionary measures to address potential risk of neurodevelopmental disorders in children born...
On 24 January 2024, the CMDh1 endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines. These measures...
Europe – Annex to the European Commission guideline on ‘Excipients in the labelling and...
This document is an annex to the European Commission guideline on Excipients in the labelling and package leaflet of medicinal products for human use.
It contains a list of excipients with a known...
Europe – European Health Union: Commission proposes pharmaceuticals reform for more accessible, affordable and...
Today, the Commission is proposing to revise the EU's pharmaceutical legislation - the largest reform in over 20 years - to make it more agile, flexible,...
