EMA report shows major expansion of real-world evidence framework in 2024-25
The European Medicines Agency (EMA) has published its third annual report on its Real-World Evidence (RWE) framework, covering February 2024 to February 2025. The report details a 47.5% increase in RWE studies to 59 total, with the DARWIN EU network expanding to 30 data partners across 16 countries, covering 180 million patients. The framework achieved a 78% feasibility rate for studies, up from 60% previously, with a median completion time of 4 months. Studies focused on drug utilisation (42%), safety monitoring (24%) and disease epidemiology (24%), supporting regulatory decision-making across multiple EMA committees and stakeholders.