DARWIN EU

Background - What is DARWIN EU®?

The European Medicines Agency (EMA) and the European Medicines Regulatory Network (EMRN) established DARWIN EU® to provide timely and reliable evidence on the use, safety and effectiveness of medicines for human use, including vaccines, from real world healthcare databases across the Europe. This capability is called the Data Analysis and Real World Interrogation Network (DARWIN EU®).

It is a federated network of real-world data sources (Data Partners), expertise and services to conduct scientific studies, operated by a Coordination centre. DARWIN EU® delivers real-world evidence from across Europe on diseases, populations and the uses and performance of medicines.

This enables EMA and national competent authorities in the European medicines regulatory network (EMRN) to use these data for decision making whenever needed throughout the lifecycle of a medicinal product. 

Introduction/Overview/Mandate

To support the establishment of the DARWIN EU®, a DARWIN EU® Advisory Board: 

  • provides strategic advice and recommendations to the project team on establishing DARWIN EU® and its future use within the EHDS;
  • ensures coordination and alignment of the project with relevant European and EU Member State initiatives and policies;
  • supports communication on DARWIN EU® with the European medicines regulatory network and other stakeholders.

For more information on the DARWIN EU® mandate click here. 

Members and representatives

Please find DARWIN EU® membership here.

Key documents