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.
Darwin EU delivers real-world evidence from across Europe on diseases, populations and the uses and performance of medicines.
This enables EMA and national competent authorities in the European medicines regulatory network to use these data whenever needed throughout the lifecycle of a medicinal product.
Darwin EU supports regulatory decision-making by:
The range of approved healthcare databases enabling distributed data access via Darwin EU will evolve and expand over time.
The former HMA/EMA Big Data Task Force originally recommended developing Darwin EU. The creation of Darwin EU features in the former EMA-HMA Big Data Steering Group workplan and the European medicines agencies network strategy to 2025.
For more information:
in 2025
from 2025
by end of February 2026
The steps below outline the process that real-world evidence delivered by Darwin EU goes through, from healthcare professionals collecting patient data to informing regulatory decisions.
Collecting data
Healthcare professionals collect patient health information in various formats.
Accessing data
Darwin EU collaborates with hospitals, registries, insurance claims, biobanks, and other sources to access the data collected from patients.
Standardising data
Darwin EU's data partners standardise all data into a single format, the Observational Medical Outcomes Partnership (OMOP) common data model, so it can be analysed faster.
Analysing data
Experts at Darwin EU use analytical methods to analyse the data and create study reports summarising the findings.
Interpreting results
EMA committees and EU regulators use the generated reports to complement other evidence when making regulatory decisions on medicines.
Supporting regulatory decisions
Regulators use the reports to support regulatory decisions that help make medicines safer and more effective for patients.
Darwin EU will connect the European medicines regulatory network to the European Commission's European 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 EU also contributes to developing the EHDS and the joint action to deliver European principles for the secondary use of health data, known as Towards European Health Data Space (TEHDAS).
Acting as an early flagship 'pathfinder' for the EHDS, Darwin EU will enable the exchange of healthcare data for use in healthcare delivery, policy-making and research across Europe, while fully complying with data protection requirements.
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EMA is the principal user of Darwin EU, by requesting studies to support its scientific evaluations and regulatory decision-making.
EMA also plays a central role in developing, launching and maintaining Darwin EU, by:
A service provider acts as the Darwin EU Coordination 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:
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.
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To support the establishment of the Darwin EU, a Darwin EU Advisory Board:
For more information:
To find the agendas and minutes of Advisory Board meetings, select the expandable panel below:
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 enable Darwin EU to use their data in its scientific studies and provide results to the Darwin EU coordination centre, in accordance with data protection rules.
Public and private institutions with access to real-world healthcare data can express interest to be a 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, patient registries and biobanks.
Visit the Darwin EU website for more information and how to apply.
In 2025, Darwin EU aims to onboard 10 new data partners.
Since its establishment in 2022, Darwin EU has onboarded 30 data partners.
Data partners were selected after consulting the Darwin EU Advisory Board and following the prioritisation criteria below:
The current Darwin EU data partners are listed in the document below.
Darwin EU is expected to bring on board a minimum of ten data partners every year.
To find all Darwin EU study protocols and reports, use the HMA-EMA catalogues of real-world data sources and studies.
In February 2022, EMA selected a service provider (Erasmus University Medical Center Rotterdam) to deliver Darwin EU, following a call for tender.
From 2022 to 2023, the service provider has:
As of 2024, Darwin EU has been fully operational.
Darwin EU routinely supports the 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 EU in the longer term.