Real-World Evidence (RWE) in Pharmacovigilance MAH Compliance and EMA’s 2026 Framework

By Vigilare Biopharma January 30, 2026Pharmacovigilance

The European Medicines Agency (EMA) is re-examining its approach to drug safety. The 2026 pharmacovigilance (PV) framework marks significant progress in using real-world evidence (RWE) to monitor medicines and inform regulatory decisions in the European Union (EU).