EMA

The work of the CHMP in 2012 and beyond was discussed at the recent TOPRA/EMA joint meeting

At the recent TOPRA joint meeting with EMA, Noel Wathion (EMA) highlighted the challenges for EMA in 2012- 2013 as it adapts to the changing environment. Budgetary cuts may lead to reprioritization and reallocation of resources in order to meet the challenge of implementation of the new Pharmacovigilance legislation. The need for more transparency in the wake of the Mediator case has resulted in EMA releasing more than 1 million pages of documents in response to requests.

Fiona Reekie (Janssen Research& Development) and Xavier Luria Oller (EMA) chaired a session looking at how critical decisions are made on new medicines and the role of patients.

The European Medicines Agency has recently released a draft concept paper on the need for a guideline on process validation of medicinal products containing biotechnology-derived proteins as active substance.

The document is available for consultation. here

This newsletter is addressed to patients, consumers and healthcare professionals' organisations and is intended to provide a monthly update on key information on human medicines produced and published by the European Medicines Agency.
The information contained in each issue has been selected based on recommendations from consulted patients, consumers and healthcare professionals and is not intended to comprise a full set of the Agency's information.