The European Medicines Agency (EMA) and the European Medicines Regulatory Network established a coordination centre to provide timely and reliable evidence on the use, safety and effectiveness of medicines for human use, including vaccines, from real world healthcare databases across the European Union (EU). This capability is called the Data Analysis and Real World Interrogation Network (DARWIN EU®).

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What will DARWIN EU deliver?

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:

  • 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, interrogating relevant data sources and interpreting and reporting study results;
  • expanding the Heads of Medicines Agency (HMA)-EMA catalogue of real-world data sources for 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 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.

Key Figures

 

~160 million

~100

~40
Patients providing data in Europe
in 2025		 Studies delivered per year
from 2025		 Data Partners
by the end of February 2026

 

Implementation Timeline

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:

  • set up DARWIN EU's operational processes and governance structures;
  • run pilot studies with data from DARWIN EU, to support EMA scientific committees and down-stream decision-makers in their decision-making and support the establishment of the EHDS.

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.