
DARWIN EU®, a network for data analysis and real-world interrogation, has successfully completed its first year of operation. The network has onboarded ten data partners and initiated four studies using real-world data from across Europe to better understand diseases, populations, and the uses and effects of medicines. DARWIN EU® generates real-world evidence to support the decision-making of EMA scientific committees and national competent authorities in EU Member States throughout regulatory processes. The network plans to onboard ten additional data partners and initiate around 16 studies in 2023. The first four studies demonstrate the benefits of DARWIN EU®, including faster performance, increased capacity, and lower costs. Results from completed studies have been provided to relevant EMA committees to support their future work. DARWIN EU® is also collaborating with stakeholders and participating in a pilot for the European Health Data Space (EHDS), ultimately delivering around 150 RWE studies per year by 2025.