The European Medicines Agency (EMA) has announced the development of a new Coordination Centre, to be known as the Data Analysis and Real World Interrogation Network (DARWIN EU).
The DARWIN EU will be introduced during a multistakeholder webinar held by the EMA on 24 February 2022, which will include a Q&A session.
The new coordination centre will develop and manage a system of real-world healthcare information across the EU. It will also allow certain scientific studies requested by medicines regulators to be carried out and, in turn, studies requested by stakeholders will be allowed at a later date.
The DARWIN EU will give the EMA and other EU member states access to reliable, real-world evidence on diseases, patient populations, and the use, safety and effectiveness of medicines – including vaccines – throughout their life cycle. In this way, the DARWIN EU will offer a vital resource in combatting future healthcare pandemics and crises.
Patients, healthcare professionals and health technology regulators will benefit from the development, regulation and surveillance of new medicines, with patients being able to access innovative treatments more quickly due to the availability of trusted real-world evidence.
The EMA is teaming up with the Erasmus University Medical Center in Rotterdam to establish the new Coordination Centre, as part of a contract agreed in June 2021.
The Centre will run scientific studies centering on research questions resulting from medicine evaluations in the EU, while maintaining a comprehensive record of data and metadata sources for medical regulators to use. All of these studies will be published and made available in the EU catalogue of observational studies.
DARWIN EU will also be a pathfinder for the European Health Data Space (EHDS). By connecting to the EHDS services, it will allow the use of EHDS in the process of medicine regulation in Europe.
The EMA will oversee the Coordination Centre, monitoring its performance and linking it to the work of the EMA medicine committees.
The initial DARWIN EU pilot studies are expected to be published in 2022.