Data Analysis and Real World Interrogation Network (DARWIN EU) | European Medicines Agency (EMA) (2025)

Darwin EU supports regulatory decision-makingby:

• providing a source of high-quality, validated real-world data on the uses, safety and efficacy of medicines;
• addressing specific questions by carrying out high-quality, non-interventional studies, including developing scientific protocols, interrogatingrelevant data sourcesand interpretingand reporting study results;
• expanding the Heads of Medicines Agency (HMA)-EMAcatalogue ofreal-world data sourcesfor use in medicines regulation and the HMA-EMA catalogue of real-world data studies.

The range of approved healthcare databases enabling distributed data access via Darwin EUwill evolve and expand over time.

The formerHMA/EMA Big Data Task Forceoriginally recommended developing Darwin EU.

The creation of Darwin EUfeatures in the former EMA-HMA Big Data Steering Group workplan and the European medicines agencies network strategy to 2025.

Watch the video below to learn more on how data from real-world healthcare settings can facilitate patients' access to safer and more effective medicines.

For more information, see:

• Real-world evidence

Darwin EU will connectthe European medicines regulatory network to the European Commission'sEuropean Health Data Space (EHDS), an initiative to promote better exchange and access to different types of health data.

While the needs and use cases of medicine regulators and decision-makers will drive Darwin EU's development, Darwin EUalso contributes to developing the EHDS and the joint action to deliver European principles for the secondary use of health data, known asTowards European Health Data Space (TEHDAS).

Acting as an early flagship'pathfinder' for the EHDS, Darwin EU will enabletheexchange of healthcare data for use in healthcare delivery, policy-making and research across Europe, while fully complying withdata protection requirements.

For more information:

• European Commission:European Health Data Space

EMAisthe principal userof Darwin EU, by requesting studies to support itsscientific evaluations and regulatory decision-making.

EMAalso plays a central role in developing, launching and maintaining Darwin EU, by:

• providingstrategic direction and setting standards;
• overseeing the coordination centre and monitoring its performance;
• ensuring close links to European Commission policy initiatives, particularly the EHDS,and delivering pilots;
• reporting to EMA'sManagement Board, the HMA and European Commission.

A service provider acts as the Darwin EUCoordination Centre and is responsible for setting up the network and managing its day-to-day operations.

EMA is working with Erasmus University Medical Center Rotterdam to:

• establish the Darwin EUcoordination centre, and support its work to build a distributed data network;
• conduct scientific studies and answer research questions supporting regulatory decision-making by EMA scientific committees and the European medicines regulatory network;
• expand the HMA-EMA catalogue of real-world data sources for use in medicine regulation and their metadata, and the HMA-EMA catalogue of real-world studies.

The Darwin EU coordination centre will be a key user of the future EHDS.

The contract was awarded to Erasmus University Medical Center Rotterdam following a call for tender for a service provider published in June 2021.

For more information:

• Darwin EU coordination centre

To support the establishment of the Darwin EU, a Darwin EUAdvisory Board:

• provides strategic advice and recommendations to the project team on establishing Darwin EUand its use of the EHDS;
• ensures coordination and alignment of the project with relevant European and EU Member State initiatives and policies;
• supports communication on Darwin EU withthe European medicines regulatory network, stakeholders and the EHDS.

For more information:

Darwin EU collaborates with data partners who help generate real-world evidence that can be used in scientific evaluations andregulatory decision-making.

Data partners enableDarwin EU to use their data in its scientific studiesandprovideresults to the Darwin EU coordination centre, in accordance with data protection rules.

Public and private institutions with access to real-world healthcare data canexpress interest to bea Darwin EU data partner.

A call for expressions of interest is open to organisations overseeing a variety of data sources, such as hospitals, primary care providers, health insurance providers, patientregistries and biobanks.

Visit the Darwin EU website for more information and how to apply.

In 2025, Darwin EUaims to onboard 10 new data partners.

Since its establishment in 2022, Darwin EU has onboarded 30 data partners.

Data partners were selected after consultingthe Darwin EU Advisory Board andfollowing the prioritisation criteria below:

• Continuous data collection (at least annual data updates)
• A lag time of less than six months in data availability for analysis and capture of health outcomes and medicines prescribing or dispensing
• Data converted into the Observational Medical Outcomes Partnership (OMOP) common data model

Thecurrent Darwin EUdata partners are listed in the document below.

To find all Darwin EU study protocols and reports, use the HMA-EMA catalogues of real-world data sources and studies.

In February 2022, EMAselected a service provider (Erasmus University Medical Center Rotterdam) to deliver Darwin EU, followinga call for tender.

From 2022 to 2023, the service provider has:

• set up Darwin EU's operational processesand governance structures;
• run pilot studieswith data from Darwin EU, to support EMAscientific committeesand down-stream decision-makersin their decision-making and support the establishment of the EHDS.

As of 2024, Darwin EUhas been fully operational.

Darwin EU routinely supportsthe evaluation work of EMA's scientific committees and the national competent authorities.

Organisations such as the European Centre for Disease Prevention and Control,Health technology assessment bodies and payers may make use of Darwin EUin the longer term.