DARWIN EU® is calling for new data partners

By HEOR Staff Writer

April 3, 2023

DARWIN EU®, a network for data analysis and real-world interrogation, has successfully completed its first year of operation. The network has onboarded ten data partners and initiated four studies using real-world data from across Europe to better understand diseases, populations, and the uses and effects of medicines. DARWIN EU® generates real-world evidence to support the decision-making of EMA scientific committees and national competent authorities in EU Member States throughout regulatory processes. The network plans to onboard ten additional data partners and initiate around 16 studies in 2023. The first four studies demonstrate the benefits of DARWIN EU®, including faster performance, increased capacity, and lower costs. Results from completed studies have been provided to relevant EMA committees to support their future work. DARWIN EU® is also collaborating with stakeholders and participating in a pilot for the European Health Data Space (EHDS), ultimately delivering around 150 RWE studies per year by 2025.

Reference url

Recent Posts

Joint Scientific Consultation EU
Joint Scientific Consultation EU Strategies for Medical Device Companies

By João L. Carapinha

June 19, 2026

The EU Joint Scientific Consultation gives medical device developers a voluntary route to obtain targeted feedback on clinical evidence plans well before formal Joint Clinical Assessment and national reimbursement decisions. Manufacturers of select high-risk technologies can align their developme...
EU Joint Clinical Assessment
Insights on EU Joint Clinical Assessment for High-Risk Medical Devices

By João L. Carapinha

June 19, 2026

EU Joint Clinical Assessment is a distinct, harmonised process that operates separately from CE marking. It produces comparative clinical evidence on selected high-risk devices to support more consistent national reimbursement decisions across EU member states. Insights from the
CAPVAXIVE Pediatric Vaccine Approval
Advancing CAPVAXIVE Pediatric Vaccine Approval for High-Risk Youth

By João L. Carapinha

June 19, 2026

The CAPVAXIVE Pediatric Vaccine Approval expands options for children and adolescents aged 2 through 17 who have completed their primary pediatric pneumococcal series yet face elevated risk due to chronic conditions such as diabetes, heart disease, kidney disease, liver disease, or lung disease. ...