DARWIN EU

EMA-led distributed network generating real-world evidence on medicine use, safety and effectiveness for regulatory decision-making.

Resource family Pharmacoepidemiology & Rwe
Resource type Distributed Real World Evidence Network
Maintained by European Medicines Agency and European Medicines Regulatory Network
Jurisdiction European Union
Status Official European medicines regulatory network RWE capability
Access Public information; regulatory study network access is governed
Official link verified 2026-09-04
Official source Visit official resource ↗

DARWIN EU generates real-world evidence from healthcare databases across Europe to support regulatory questions throughout the medicines lifecycle. EMA and national competent authorities use the network to request and interpret non-interventional studies relevant to safety, use and effectiveness.