General
General information about DARWIN EU® can be found under the About menu. Below are some FAQs we receive.
The EMA will be responsible for providing leadership and direction, setting standards for DARWIN EU®, contracting, instructing and overseeing the Coordination Centre and monitoring its performance.
The overall operation of DARWIN EU® is overseen by the Management Pillar and with guidance from its Advisory Boards. These boards are composed of the Scientific Advisory Board, the Ethical Advisory Board, and the Data Source Prioritisation Committee. The initiative also receives oversight from the DARWIN EU® Advisory Board at EMA, which you can read more about here.
At present, the DARWIN EU® CC provides a service to EMA and the National Competent Authorities (NCAs) of the Member States, and therefore receives study requests from EMA on behalf of those organisations. As the network expands, DARWIN EU® may perform studies requested by EMA on behalf of third parties such as other EU level health agencies (e.g. European Centre for Disease Prevention and Control (ECDC), health technology assessment bodies or payers. You can read more about it here.
Studies are published on the European Union Electronic Register of Post-Authorisation Studies (EU PAS Register), which you can access here.
For the most up-to-date list of studies that DARWIN EU® has produced, search for the term “DARWIN EU” in the 'Title of study' field. Otherwise, you can check the updated list of studies on this website here.
You can get in touch with the Coordination Centre through email:
Joining the Network
If you are interested in joining the network, you can read more about the process here. Below are some FAQs on the process.
To be considered as a candidate DP, the first step is to create an entry in the HMA-EMA Catalogue of Real-World Data sources.
The onboarding process consists of several quality and technical checks to ensure readiness for DARWIN EU® studies, plus explanation of the terms and conditions for participation and agreement on the legal provisions that will apply to the relationship between you and the CC. Its duration can vary between 1 and 2 months, ordinarily.