The Heads of Medicines Agencies (HMA), in collaboration with the European Medicines Agency (EMA), has released the third report on the integration of Real-World Evidence (RWE) in regulatory decision-making.
From February 2024 to February 2025, the number of RWE studies grew by 47.5%, with improved feasibility thanks to the expansion of DARWIN EU®, now including 30 data partners across 16 countries and covering around 180 million patients.
The studies addressed a range of topics requested by a diverse range of regulatory and public health decision-makers. DARWIN EU® studies had a median duration of 4 months, enabling timely input regulation timelines. Key improvements highlighted in the report include:
• Enhanced data quality through strengthened validation checks
• Faster analysis of data thanks to pre-approved protocols
• The launch of the HMA-EMA RWD catalogues improved the transparency in communication of study results
The report confirms that RWE is now a firmly established and valuable tool in regulatory decision-making across Europe.
Read the full report to explore how RWE is shaping the future of medicines regulation in Europe:
Real-world evidence framework to support EU regulatory decision-making