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.

DARWIN EU® works to deliver studies as they are described in its Catalogue of Standard Data Analyses. These are categorised as Off-the-shelf, Complex, Very Complex and Routine Repeated. 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.

The following organisations contribute to the establishment and operational phases of the Coordination Centre:

Fore more information see here.

At present, there is no necessity to add any additional subcontractors or organisations to help deliver the requested services. Erasmus University Medical Centre is the current contractor, with its subcontractors having already been added during the tendering process. 

You can get in touch with the Coordination Centre through email: This email address is being protected from spambots. You need JavaScript enabled to view it. or the contact form.

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.

Yes, unless duly justified, in which case an appropriate justification should be included.

The HMA-EMA Catalogue of Real-World Data source is intended for public use, and you can read its associated Data Protection Notice here.

You can access the DARWIN Data Protection Notice here.

No, this is a continuously open call, but please bear in mind the cut-off dates (30th April, 31st October) for review and selection.

No. The CC may contact you to clarify certain aspects of your datasets, or to invite you to initiate the formal onboarding process. Until the latter is successfully completed and an agreement signed, you are not a DARWIN EU® DP.

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.

No. The onboarding process has to be successfully completed and an agreement with the CC has to be signed.