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
Select service provider to deliver the DARWIN EU Coordination Centre
Establish DARWIN EU Advisory Board
Support EDHS pilot
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
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
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
Leverage the EU Health Data Space
Increase geographical coverage, scope and regulatory uses of healthcare data in DARWIN EU