The Pharmacovigilance Risk Assessment Committee (PRAC) is the European Medicines Agency committee responsible for evaluating and recommending actions on medicine safety issues across the EU.
PRAC reviews safety signals, risk management plans, periodic safety reports, and post-authorization safety studies to determine whether new risks are emerging or existing risks need stronger controls. Its recommendations can lead to labeling changes, additional studies, or risk minimization measures that affect global development and lifecycle management. Sponsors running multinational programs often align pharmacovigilance processes to support PRAC expectations alongside FDA requirements. PRAC outputs are frequently referenced in safety strategy decisions because they reflect a centralized EU view of benefitñrisk at the population level.