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.