EMA: Periodic Signal Detection for Centrally Authorised Products Based on Reaction Monitoring Reports

To describe the process by which identification of new safety signals for Centrally Authorised medicinal Products (CAPs) is conducted periodically in the Pharmacovigilance and Risk Management Sector (P-PV) of the European Medicines Agency (EMA) based on Reaction Monitoring Reports (RMRs) generated from the EudraVigilance (EV) database. The purpose of this procedure is to ensure that these processes, including dedicated regular meetings and communication of validated signals to Rapporteurs, are handled in an efficient and consistent way and by doing so support pharmacovigilance and risk management at EU level.