EMA updates the Rules of Procedure for PRAC

The European Medicines Agency (EMA) has published an updated version of the Rules of Procedure for Pharmacovigilance Risk Assessment Committee (PRAC).

The update clarifies the arrangements for the participation of experts from international organizations or regulatory authorities outside the European Economic Area (EEA), appointed by the EMA, in PRAC meetings under the OPEN framework. This aims to facilitate international cooperation and exchanges of scientific views, while maintaining PRAC’s fundamental role and responsibilities.