Just published: 3rd progress report on the use of real-world evidence (RWE) in medicines regulation (February 2024 – February 2025)
Key highlights:
📌 59 RWE studies conducted – nearly 50% more than during the previous reporting period;
📌 DARWIN EU became the main pathway for generating evidence with a 3-fold increase in completed studies;
📌 The network now has 30 data partners across 16 European countries, enabling access to data from 180 million patients.
Examples of real-world impact:
✅ A study on the widely used antibiotic, doxycycline, helped EMA’s safety committee, the PRAC, confirm no link to suicidality;
✅ A study on anti-migraine medicines supported the PRAC in assessing safety signals on insomnia, erectile dysfunction and high blood pressure. The conclusion was that no further action was needed, which helped ease safety concerns;
✅ A study on respiratory syncytial virus (RSV) highlighted its impact on vulnerable populations such as infants and older adults and the unmet clinical need in this group, guiding EMA in preparing future vaccine effectiveness studies.