The European Medicines Agency (EMA) and the European Medicines Regulatory Network (EMRN) established Darwin EU to deliver real-world evidence in Europe.
Darwin EU works with data from real-world healthcare databases. This includes data from doctors, hospitals and registries.
These data inform about the use, safety and benefits of medicines, including vaccines.
EMA and national competent authorities in the network can use these data whenever needed throughout a medicine's lifecycle.
Darwin EU was established in 2022, at the recommendation of the former Heads of Medicines Agency (HMA)-EMA Big Data Task Force.
Its creation features in the former EMA-HMA Big Data Steering Group (currently the Network Data Steering Group) workplan and the European medicines agencies network strategy to 2025.
For more information about EMA's work on real-world evidence, see:
in 2026
since 2022
as of 2026
Darwin EU study outcomes include:
To find all Darwin EU study protocols and reports, use the HMA-EMA catalogue of real-world data sources and studies.
Darwin EU supports regulatory decision-making by:
The range of approved healthcare databases enabling distributed data access via Darwin EU has evolved and expanded each year since its establishment.
Watch the video below to learn how real-world data can facilitate patient access to safer and more effective medicines.
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 is enabling the European medicines regulatory network's connection to the European Health Data Space (EHDS). This EU regulation promotes better exchange and access to different types of health data.
Darwin EU helped paved the way for the EHDS regulation through its access to healthcare data that can support policy-making and regulatory science.
EMA is working with the network and the European Commission to implement the EHDS regulation, which entered into force in March 2025.
EMA is the main user of Darwin EU, requesting studies to support its scientific evaluations and regulatory decision-making.
EMA also plays a central role in funding, developing and maintaining Darwin EU. It does so through the following activities:
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.
Interested data holders can get in contact via the dedicated Darwin EU website.
Darwin EU has onboarded 40 data partners since its establishment in 2022.
The current Darwin EU data partners are listed in the document below.
The Darwin EU coordination centre contributed to building the project's data network.
The Erasmus University Medical Center Rotterdam is currently running Darwin EU's coordination centre. It is working closely with EMA to:
The Erasmus University Medical Center Rotterdam received this contract following a call for tender for a service provider published in June 2021.
For more information:
The Darwin EU Advisory board supports the work of this project by:
For more information, see:
To find the agendas and minutes of Advisory Board meetings, select the expandable panel below:
An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.
The tracking of updates begins in March 2026.
4 March 2026
Page revamped to include a summary of Darwin EU study outcomes and visual abstracts from ten key Darwin EU studies. Revamp also features updated figures on Darwin EU, including the number of data partners.