Data Analysis and Real World Interrogation Network (DARWIN EU)

Darwin EU logo
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®).

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:

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 EDHS, 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. 

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:

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.  

The data partners enable DARWIN EU to use their data in its scientific studies, and provide analysis results to the DARWIN EU coordination centre, in accordance with data protection rules.

Data partners were selected after consultation with 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

In November 2022, DARWIN EU completed the onboarding of the first set of data partners with access to real-world healthcare data from sources such as hospitals, primary care, health insurance, registries and biobanks.

They are listed below: 

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

Timelines

      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 will:

      • 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.

      Figure 1: Overview of DARWIN EU timelines

      2021

      DARWIN EU - 2021

      Project initiation

      Select service provider to deliver the DARWIN EU Coordination Centre

      Establish DARWIN EU Advisory Board

      Support EDHS pilot

       

       

      2022

      DARWIN EU timeline - 2022

      DARWIN EU establishment and pilot mode

      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

      2023

      DARWIN EU timeline - 2023

      Developing and using DARWIN EU

      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

      2024

      DARWIN EU timeline - 2024

      Full operation mode

      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

       

       

      2025

      DARWIN EU timeline - 2025

      Leverage the EU Health Data Space

      Increase geographical coverage, scope and regulatory uses of healthcare data in DARWIN EU

       

       

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