The Data Analysis and Real World Interrogation Network (DARWIN EU) is a coordination centre being set up by the European Medicines Agency (EMA) to provide timely and reliable evidence on the use, safety and effectiveness of medicines for human use, including vaccines.
The formation of DARWIN EU is a by-product of the EMA-HMA Big Data Steering Group workplan and the European medicines agencies network strategy to 2025. DARWIN EU will enable the EMA and national competent authorities in the European Medicines Regulatory Network (EMRN) to use real-world evidence from across Europe to support regulatory decision making by:
- Establishing and developing a catalogue of observational data sources for use in medicines regulation
- Providing a source of high-quality, validated real world data on the uses, safety and efficacy of medicines
- Addressing specific questions through high-quality, non-interventional studies which include developing scientific protocols, interrogating relevant data sources and interpreting and reporting study results.
DARWIN EU will link the EMRN to the European Commission’s (EC) European Health Data Space (EHDS) which is an initiative to promote better exchange and access to different types of health data. Whilst the EMA will be a principal user of DARWIN EU, it will also play a key role in developing, launching and maintain DARWIN EU through:
- Provision of strategic direction and setting standards
- Oversight of the coordination centre and monitoring of its performance
- Preserving close links to EC policy initiatives such as the EHDS and delivering pilots
- Reporting to the EMA’s Management Board, the HMA and EC.
A service provider will act as the DARWIN EU Coordination Centre and will take responsibility for setting up the network and running it on a day-to-day basis. It is expected that DARWIN EU will be fully operational in 2024.
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