Posted by Michael Wonder on 22 May 2017
Green light given for new EudraVigilance system for collection and monitoring of suspected adverse reactions
22 May 2917 - Management Board endorsement starts countdown for stakeholders to get ready for launch of improved system in November 2017.
The EMA will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area. The new version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions.
Users of the system, i.e. national competent authorities, marketing authorisation holders and sponsors of clinical trials, have to make final preparations to ensure that their processes and local IT infrastructure are compatible with the new system and the internationally agreed format.
