Added on 6 March 2024:
'Key figures' section
'How DARWIN EU uses data for the benefit of patients' section

Updated on 6 March 2024:
'Data partners' section

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 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: 

  • establishing and expanding a catalogue of observational data sources for use in medicines regulation;
  • 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.

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 EMA-HMA Big Data Steering Group workplan and the European medicines agencies network strategy to 2025. 

For more information:

Key figures

~130 million
Patients providing data

in 2024

140+
Studies delivered per year

by 2025

~40
Data partners

by end of 2025

How DARWIN EU uses data for the benefit of patients

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.

 

  1. Collecting data

    Healthcare professionals collect patient health information in various formats.

  2. Accessing data

    DARWIN EU collaborates with hospitals, registries, insurance claims, biobanks, and other sources to access the data collected from patients.

  3. 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.

  4. Analysing data

    Experts at DARWIN EU use analytical methods to analyse the data and create study reports summarising the findings.

  5. Interpreting results

    EMA committees and EU regulators use the generated reports to complement other evidence when making regulatory decisions on medicines.

  6. Supporting regulatory decisions

    Regulators use the reports to support regulatory decisions that help make medicines safer and more effective for patients.

Related information materials

Interaction with the European Health Data Space

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.

For more information: 

EMA's role

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:

  • providing strategic 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's Management Board, the HMA and European Commission.

A service provider acts as the DARWIN EU Coordination Centre and be responsible for setting up the network and managing its day-to-day operations.

Coordination centre

EMA is working with Erasmus University Medical Center Rotterdam to:

  • establish the DARWIN EU Coordination 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;
  • maintain a catalogue of real world data sources for use in the regulatory context and their metadata. 

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:

Advisory board

To support the establishment of the DARWIN EU, a DARWIN EU Advisory Board

  • provides strategic advice and recommendations to the project team on establishing DARWIN EU and 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 with the European medicines regulatory network, stakeholders and the EHDS.

For more information:

DARWIN EU Advisory Board: Mandate

DARWIN EU Advisory Board: Membership

Data partners

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 apply 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 2024, DARWIN EU aims to onboard 10 new data partners.

Since its establishment in 2022, DARWIN EU has onboarded 20 data partners.

Data partners were selected after consulting the DARWIN EU Advisory Board and following 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

The current DARWIN EU data partners are listed in the document below.

DARWIN EU data partners onboarded in phases I and II

DARWIN EU is expected to bring on board a minimum of ten data partners every year.

Studies

To find all DARWIN EU study protocols and reports, use the European Union electronic Register of Post-Authorisation Studies (EU PAS Register).

Implementation timeline

In February 2022, EMA selected a service provider (Erasmus University Medical Center Rotterdam) to deliver DARWIN EU, following a call for tender. 

In 2022 and 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. 

In 2024, EMA expects DARWIN EU to be fully operational. At this stage, DARWIN EU will routinely support the evaluation work of EMA's scientific committees and the national competent authorities. 

Organisations such as the European Centre for Disease Prevention and ControlHealth technology assessment bodies and payers may make use of DARWIN EU in the longer term.

Timeline

  1. 2021

    Project initiation

    darwin-eu_2021.png
    • Select service provider to deliver the DARWIN EU Coordination Centre  
    • Establish DARWIN EU Advisory Board 
    • Support EHDS pilot
  2. 2022

    DARWIN EU establishment and pilot mode

    DARWIN EU timeline - 2022
    • Define governance structures, contract models and processes 
    • Run early pilot studies to support EMA committees 
    • Provide first catalogue of real world data sources and standard analyses 
    • Establish connectivity with EHDS
  3. 2023

    Developing and using DARWIN EU

    DARWIN EU timeline - 2023
    • Launch publicly-available DARWIN EU website
    • Work with established data permit authorities
    • Test business process to access and analyse healthcare data
    • Run pilot studies to support more EMA committees
  4. 2024

    Full operation mode

    DARWIN EU timeline - 2024
    • Conduct studies and answer questions to support EMA scientific committees and national competent authorities
    • DARWIN EU fully operational with involvement of data partners and medicine regulators
  5. 2025

    Leverage the EU Health Data Space

    DARWIN EU timeline - 2025
    • Increase geographical coverage, scope and regulatory uses of healthcare data in DARWIN EU

How useful do you find this page?