EudraVigilance (EU)
The European system for managing and analysing information on suspected adverse reactions to medicines authorised in the European Economic Area. EudraVigilance supports the EMA's pharmacovigilance activities and enables signal detection across the EU pharmaceutical market.
Technical Context
EudraVigilance is the European system for managing information on suspected adverse reactions to medicines. Marketing authorisation holders must report all EU serious ICSRs (Individual Case Safety Reports) within 15 days. The EudraVigilance database contains over 17 million ICSRs. The EMA's signal detection system uses: disproportionality measures (proportional reporting ratio, reporting odds ratio), Bayesian methods (Bayesian Confidence Propagation Neural Network — BCPNN), and time-to-onset analysis. The Pharmacovigilance Risk Assessment Committee (PRAC) evaluates signals and recommends regulatory actions (label changes, risk minimisation measures, or referral procedures). The EudraVigilance access policy provides public access to adverse reaction data through the adrreports.eu website, promoting transparency while protecting patient privacy.