EudraVigilance is the European Union system for managing and analysing information on suspected adverse reactions to medicines. It supports electronic exchange of individual case safety reports (ICSRs), safety monitoring and signal evaluation across the European medicines regulatory network.
Why a pharmacovigilance professional uses it
Marketing authorisation holders, sponsors and regulatory authorities interact with different parts of the EudraVigilance ecosystem for ICSR transmission, case management, data retrieval and safety surveillance. The system includes the EudraVigilance Gateway, EVWEB and analytical components such as EVDAS.
Important distinction
The public website adrreports.eu provides public access to aggregated information from EudraVigilance. It is not the EudraVigilance reporting system itself. QPPV.com therefore links this resource to EMA's official EudraVigilance pages and treats the public adverse-reaction portal as a separate resource.