Published by EMA on 05-May-2014

The European Medicines Agency has published an updated list of active substances contained in authorised medicines for which a lead Member State has been appointed to monitor data in EudraVigilance, in order to validate and confirm signals on behalf of the European Union (EU) regulatory network.

The overall goal of the work-sharing model, whereby one Member State is responsible for monitoring a single active substance contained in a medicine authorised through national, mutual-recognition or decentralised procedures, is to further strengthen the signal detection system in the EU and optimise use of resource across the network for the benefit of public health.