European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance

Pharmacoepidemiol Drug Saf. 2011 Oct;20(10):1021-9. doi: 10.1002/pds.2209.


Purpose: A review of post-authorisation studies requested in 2007 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) was undertaken to determine compliance and the need for research capacity in the European Union (EU), with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP).

Methods: Information from the EMA's electronic records management systems was analysed.

Results: As of 31 January 2010, of the 60 relevant studies identified, 52 had been progressed to being able to start data collection (including six merged into a single study). Of the remaining eight studies, the agreement of the CHMP that a proposed study was no longer required is documented for six, with a final decision having not been reached for another study and an acknowledgement by the CHMP that a further study would not be progressed. Of the 47 studies that could therefore have commenced data collection or extraction, 38 were ongoing, four were complete and five had not yet started. Most studies were conducted within the EU.

Conclusion: Compliance with the request of the CHMP to conduct studies is very good. The review identified the need for careful consideration of the necessity of studies and of timely dialogue on protocols in advance of a CHMP opinion. The need for expertise and capacity within the EU for the conduct of post-authorisation studies is confirmed. ENCePP as a transparency and excellence network and as an initiative to build research capacity will enhance post-authorisation medicines research.

MeSH terms

  • Databases, Factual
  • Drug Approval / statistics & numerical data*
  • Drug Industry
  • Drug-Related Side Effects and Adverse Reactions* / epidemiology
  • European Union
  • Humans
  • Legislation, Drug
  • Pharmacovigilance*
  • Product Surveillance, Postmarketing / statistics & numerical data*
  • Product Surveillance, Postmarketing / trends