EMA to focus on pharmacovigilance and supporting development in 2014

The European Medicines Agency has published its work program for 2014 with a focus on legislative developments.

One of the main areas of focus will be the development of the European pharmacovigilance legislation that became operational in July 2012. The legislation brought one of the biggest changes to the legal framework for human medicines since the creation of the EMA in 1995. Among the priority activities are the further development of methods for collecting best evidence, enhancement of functionalities of EudraVigilance, the European database on adverse drug reactions, the development of a repository for periodic safety update reports (PSURs) as well as a system for monitoring the scientific literature for signal detection.

The EMA will also continue the implementation of the falsified medicines directive that came into force in 2013 and will closely monitor and contribute to the debate on new legislative proposals on the conduct of clinical trials and on veterinary medicines.