EMA to Outline Approach to EudraVigilance Upgrade

The European Medicines Agency plans to issue a “go-live” strategy for regulators, drug companies and other stakeholders in the run-up to the Nov. 22 launch of an upgraded EudraVigilance system for reporting adverse drug reactions.

The announcement, expected after Oct. 1, will include the anticipated downtime for the existing EudraVigilance system, to accommodate the upgrade, and the reporting arrangements for stakeholders.

Under the new system, drug companies no longer will need to submit adverse-event reports to individual national regulatory agencies, instead submitting reports to EudraVigilance only. And member states no longer need to submit data to the World Health Organization, with EudraVigilance providing that information directly to WHO’s Uppsala Monitoring Centre.