DARWIN EU^® Coordination Centre to integrate real-world evidence into medicines regulation

The European Medicines Agency (EMA) has announced the establishment of the Coordination Centre for the Data Analysis and Real World Interrogation Network (DARWIN EU^®). The centre will 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, other stakeholders too.

The aim of DARWIN EU^® is to give EMA and national competent authorities in EU Member States access to valid and trustworthy real-world evidence. The data could be on diseases, patient populations, and the use, safety and effectiveness of medicines, including vaccines, throughout their lifecycle.

EMA stated: “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.”

The regulator explained that the availability of reliable real-world evidence could help make innovative treatments available to patients faster, while also supporting more informed regulatory decision-making.

EMA will be working with Erasmus University Medical Center Rotterdam to establish the DARWIN EU^® Coordination Centre. The contract was awarded to Erasmus University Medical Center Rotterdam following a call for tender for a service provider published in June 2021. The contractor will set up the necessary infrastructure of the Coordination Centre and establish the required business services. 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.

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.

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.

DARWIN EU^® is the first priority deliverable of the EMA-HMA Big Data Steering Group workplan and contributes to the delivery of the European Medicines Agencies Network Strategy to 2025.

To find out more about the project, EMA is hosting a multi-stakeholder information webinar to introduce DARWIN EU, highlight opportunities for collaboration and answer questions on 24 February 2022.