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Data Analysis and Real World Interrogation Network (DARWIN EU)

EMA initiated the establishment of the Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®).

The role of the Coordination Centre is to develop and manage a network of real-world healthcare data sources across the EU and to conduct scientific studies requested by medicines regulators and, at a later stage, requested by other stakeholders.

By supporting decision-making on the development, authorisation and surveillance of medicines, a wide range of stakeholders will benefit, from patients and healthcare professionals to health technology assessment bodies and the pharmaceutical industry. Additionally, DARWIN EU® will provide an invaluable resource to prepare for and respond to future healthcare crises and pandemics.

EMA will be working with Erasmus University Medical Center Rotterdam to establish the DARWIN EU® Coordination Centre. It will run scientific studies to answer research questions that come up during the evaluation of medicines in the EU and also maintain a catalogue of real-world data sources and metadata for use in medicine regulatory activities. All studies will be published in the EU catalogue of observational studies.

The first DARWIN EU® pilot studies will be delivered in 2022. EMA will oversee the Coordination Centre, connect it to the work of the EMA medicines committees and monitor its performance.

Overview of DARWIN EU timelines

2021

 

Project initiation

Select service provider to deliver the DARWIN EU Coordination Centre

Establish DARWIN EU Advisory Board

Support EDHS pilot

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

 

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

 

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

 

Leverage the EU Health Data Space

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

More on DARWIN from EMA: https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-real-world-interrogation-network-darwin-eu