2023 PRAC’s Work Plan

EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has outlined its 2023 work plan, focusing on key objectives that will shape regulatory decision-making. Top priorities include enhancing data generation on medicine safety in pregnancy and breastfeeding, expanding the use of real-world evidence (RWE) in PRAC evaluations, and contributing expert input for guidance on RWE use in regulatory contexts. Additionally, PRAC aims to oversee and advise on impact research conducted through DARWIN EU, with insights available via the EU PAS Register.