The European Medicines Agency (EMA) has increasingly recognised the value of real-world data (RWD) and real-world evidence (RWE) in this ever-changing regulatory landscape. Regulatory decisions have been traditionally based primarily on data from randomised controlled trials. However, RWD – information collected from everyday clinical settings such as patient registries, health records, and insurance claims – has emerged as a complementary resource. The EMA views RWE as a key tool for enhancing drug development, supporting adaptive licensing, and providing a more accurate assessment of the safety and effectiveness of medicines once they are on the market. The agency emphasises a structured approach to incorporating RWD through frameworks, pilot pro grammes, and data standardisation initiatives. Through various initiatives, includ ing the DARWIN EU® initiative and its Big Data Steering Group, the EMA is working to ensure the scientific validity and regulatory acceptability of RWE across the medicinal product lifecycle.

Medical Writing. 2025;34(3):16–22.  https://doi.org/10.56012/rhcw1179