DARWIN EU Update
DARWIN EU is a federated network of data, expertise and services, created to support better decision-making throughout the product life cycle by generating reliable evidence from Real World Data (RWD).
It is a project initiated in 2022, funded by the European Medicines Agency (EMA), which, together with the European Medicines Regulatory Network (EMRN), established a coordination centre to provide reliable evidence on the use, safety, and effectiveness of medicines.
DARWIN EU® contributes to regulatory decision-making through:
- provision of scientific expertise, to support the studies and analyses required by the EMA and the ERMN;
- management and updating of a structured catalogue of data sources and studies based on RWDs;
- design and conduct of studies, including protocol development, querying relevant data sources, analysing and disseminating results;
- development and expansion of the federated network of data partners, ensuring that new partners comply with the standards required for use in the regulatory field;
- provision of training, governance and operational support activities.
Highlights (February 2024 – February 2025)
- DARWIN EU® has successfully completed its third year of operation. The network has expanded to 30 data partners, allowing access to the data of about 180 million patients from 16 European countries
- The proportion of feasible studies addressing initial requests has increased compared to the previous period (78% vs. 60%)
- The median duration of the DARWIN EU® studies was 4 months from protocol approval to the submission of results
- The studies addressed a range of topics, including drug utilization (42%), safety (24%) and disease epidemiology (24%)
