DARWIN EU® has multiple actors: Data Partners, Coordination Centre, European Medicines Agency, EU Medicines Regulatory Network, and other organisations.

Data Partners

DARWIN EU® collaborates with data partners who help generate real-world evidence that can be used in scientific evaluations and regulatory decision-making. Data partners are partners who have access to raw data in-house or remotely, through ownership, public contract, third-party agreement or commercial license. Data partners enable DARWIN EU® to use their data in its scientific studies by executing analytic packages, and provide analysis results to the DARWIN EU Coordination Centre, in accordance with data protection and governance rules. For more information see the Data Network page.

Coordination Centre

The DARWIN EU Coordination Centre (CC) has a key function in DARWIN EU®. The CC provides a structure for developing and managing the network of data partners, including their training on processes and study methods, evaluating their eligibility for performing studies, and monitoring the data quality. The CC will also be responsible for implementing and operating all the steps in the study execution process, from feasibility requests for studies up until the final delivery of the study report to the EMA, where results are to be integrated within the EU regulatory decision making process. In addition, the Coordination Centre will be responsible for methodological developments for DARWIN EU®, as directed and instructed by EMA, and to interact with other relevant initiatives. The Erasmus University Medical Center Rotterdam was selected as contractor in a public tendering procedure published in June 2021 to setup the Coordination Centre for the EMA. For more information see the Coordination Centre page.

European Medicines Agency

The EMA is responsible for providing leadership and direction, setting standards for DARWIN EU®, contracting, instructing and overseeing the Coordination Centre and monitoring its performance. For questions raised by the EU Medicines Regulatory Network requiring additional evidence to support regulatory decision-making, the EMA will coordinate the definition of the research question and define, with the requesting body, the study objectives and possible study design options such as the study population, exposures, outcomes and statistical measures. This information will be communicated to the Cordination Centre for a further feasibility assessment. Based on the feasibility assessment, the EMA, in consultation with the Cordination Centre, will decide on the relevance of conducting a study, specify eligibility criteria for the databases to be included, identify relevant databases and define the evidentiary standards to be applied in the studies (e.g., data quality). The EMA will process the results of the analyses and the report of specific studies, feeding results into decision-making, as appropriate. To support the establishment of the DARWIN EU, a DARWIN EU Advisory Board has been set up by EMA.

EU Medicines Regulatory Network

The EU Medicines Regulatory Network includes the EMA (encompassing its scientific committees and working parties), national competent authorities (NCAs) of Member States in the European Economic Area (EEA) and the European Commission. During the operation of DARWIN EU®, the need for additional real-world evidence identified within the EU Medicines Regulatory Network to support regulatory activities will be submitted to and further discussed with EMA.

Other Organisations

Interactions between EMA and other organisations, institutions and projects can take place to improve the infrastructure, methodological standards and operational processes of the DARWIN EU® network. These interactions could take place with, for example:

• the European Health Data Space (EHDS), of which DARWIN EU® will be a key user and will need to be fully integrated and use the services provided by the EHDS;
• ongoing EU and national projects in scope of DARWIN EU® and relevant to the quality, transformation, maintenance or analysis of real-world datasets, including European networking initiatives such as the European Health Data Evidence Network (EHDEN) project, European platforms for registries or the European Reference Networks (ERNs), which has established registry platforms for rare diseases;
• the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) network, for integration and continuously updating of good methodological practice in pharmacoepidemiology, identification of data sources and registration of studies;
• regulatory authorities in third countries, to learn from their experience and to integrate learnings such as governance and methodological aspects.