The European Medicines Agency (EMA) uses Data Analysis and Real-World Interrogation Network (DARWIN EU), a data network that became fully operational in 2024, to generate real-world evidence on medicines and vaccines.

The system provides regulators with access to health data across Europe to assess the use, safety, and effectiveness of these products.

DARWIN EU links health databases from multiple European countries and delivers real-world evidence from across Europe on diseases, populations, and the uses and performance of medicines. This has enabled the EMA and national regulators to make evidence-based decisions regarding the development and use of medicines. 

Launched by the EMA and the European Medicines Regulatory Network, this initiative provides timely and reliable real-world evidence on medicines for human use, including vaccines, across the EU.

Since its award in 2022 to the Erasmus University Medical Center in Rotterdam, Netherlands, the DARWIN EU project has made substantial progress. Governance structures and operational processes are now in place, and pilot studies have been completed to provide evidence for EMA’s scientific committees.

Currently, the DARWIN EU Coordination Centre serves the EMA and national competent authorities in the member states, managing study requests on behalf of these organisations. 

With the expansion of the network, DARWIN EU will also be able to conduct studies for other European agencies, such as the European Centre for Disease Prevention and Control, health technology assessment bodies, and funding bodies.

Studies are classified by complexity — ready to use, complex, very complex, and routine — and are published in the EU electronic register of Post-Authorisation Studies.

According to the DARWIN EU, by 2025, data from 181,128,000 patients across Europe will contribute to approximately 100 studies per year involving approximately 40 partners. Working with the EMA and its Scientific Technical Committee, the coordination centre continues to expand the network by adding new partners and data sources while integrating advanced infrastructure and techniques.

Beyond its regulatory role, DARWIN EU contributes to the development of the European Health Data Space (EHDS) and the joint initiative Towards the European Health Data Space which aims to establish common principles for the secondary use of health data.

As a flagship project within the EHDS, DARWIN EU enables the secure exchange of health data to strengthen healthcare, guide policymaking, and advance research across Europe while fully complying with data protection requirements.

This story was translated from El Medico Interactivo.