We’re proud to share the latest progress in integrating Real-World Evidence (RWE) into regulatory decision-making; 3rd report on the experience gained with regulator-led studies from February 2024 to February 2025, aligned with the EMRN Strategy to 2028 and in collaboration with European Medicines Agency.
⏱️ Faster insights: DARWIN EU® studies had a median duration of 4 months, enabling timely regulatory input.
🔍 Quality & transparency: Enhanced data quality checks, standardized definitions, and the use of pre-approved protocols have streamlined analysis. The launch of the HMA-EMA RWD catalogues further supports transparency and collaboration.
📈 This report confirms that RWE is now a fully enabled and increasingly valuable tool across the full spectrum of regulatory use cases.
🔗 Read the full report to explore how RWE is shaping the future of medicines regulation in Europe:
https://lnkd.in/dGPhW2FV