EMA regulatory perspective – European Parliament debate on Real World Data

30.11.2025

In this resource, we explore the European Medicines Agency’s (EMA) regulatory perspective on the use of real‑world data (RWD), as presented during a European Parliament debate. The article highlights how RWD is increasingly recognised as a valuable complement to clinical evidence in regulatory decision‑making, helping to inform the development, safety and effectiveness assessment of medicines across the EU. The article is based on a presentation by Xavier Kurz, Head of the Surveillance and Epidemiology Service at the European Medicines Agency.

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