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

EUDAMED Implementation 2026
EUDAMED Implementation 2026: Key Changes and National Adaptations

By HEOR Staff Writer

May 22, 2026

The EUDAMED Implementation 2026 will require mandatory use of four key modules in the European database on medical devices from 28 May 2026. These cover registration of economic operators, device registration via UDI, notified bodies and certificates, plus market surveillance, following earlier v...
Portugal health spending 2025
Portugal Health Spending 2025 Reaches Record €4.417 Billion Amid Rising Demand
Portugal health spending 2025 hit a fresh peak as the country’s publicly funded National Health Service recorded its highest annual outlay on medicines, reaching €4.417 billion according to Infarmed data. This total, already net of industry rebates and contributions, was propelled chiefly by expa...
First-in-Human Trials
First-in-Human Trials: Foundations and Market Implications in Health Economics

By HEOR Staff Writer

May 21, 2026

First-in-Human Trials mark the initial transition of a drug candidate from extensive preclinical research into human subjects, supplying the earliest clinical evidence on safety, pharmacokinetics, and pharmacodynamics to inform later development stages. These studies rely on a comprehensive found...