EMA - Launch of the establishment phase of DARWIN EU® and the initiation of the Coordination Centre

10th February 2022

EMA is initiating the establishment of the Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU®) – see EMA press release Initiation of DARWIN EU® Coordination Centre advances integration of real-world evidence into assessment of medicines in the EU | European Medicines Agency (europa.eu).

ABOUT DARWIN EU®

The vision of DARWIN EU® is to support EU regulatory decision-making on the development, authorisation and surveillance of medicines by giving EU medicines regulators access to valid and trustworthy real-world evidence, for example on diseases, patient populations, and the use, safety and effectiveness of medicines including vaccines throughout the lifecycle of a medicinal product.

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

DARWIN EU® will also act as a pathfinder for the European Health Data Space (EHDS) and will ultimately connect to the EHDS services, enabling the use of the EHDS in the context of medicines regulation in Europe.

ABOUT THE COORDINATION CENTRE

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. EMA will be working with Erasmus University Medical Center Rotterdam to establish the DARWIN EU® Coordination Centre. The contract was awarded to them following a call for tender published in June 2021.

ABOUT THE ESTABLISHMENT PHASE

EMA will begin working with the Coordination Centre to ensure that the first DARWIN EU® pilot studies are delivered in 2022. EMA will set standards, oversee the Coordination Centre, connect it to the work of the EMA medicines committees and monitor its performance.

REGISTER FOR DARWIN EU® MULTI-STAKEHOLDER WEBINAR

Want to know more? A multi-stakeholder information webinar will be organised by EMA on 24 February 2022 to introduce the establishment of DARWIN EU®, highlight opportunities for collaboration and answer questions. You can register here.

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