Use of real-world evidence in regulatory decisions – new report shows 47% rise in EMA real-world data studies

EMA has published a new report on the studies conducted by EMA using real-world data. This report highlights the continued progress in integrating real-world evidence into regulatory decision-making, aligned with the European Medicines Regulatory Network (EMRN) strategy to 2028. 

During the reporting period (February 2024 – February 2025), 59 studies were conducted, marking a 47.5% increase compared to the previous year. Notable studies informing regulatory decisions include assessing the risk of suicidality with doxycycline and GLP-1 agonists, assessing safety and effectiveness of mpox vaccination, and describing the epidemiology of respiratory syncytial virus. Additionally, the DARWIN EU network expanded from 20 to 30 data partners, significantly enhancing access to data from approximately 180 million patients from 16 European countries.

The research topics addressed were initiated by a diverse range of regulatory and public health decision-makers, including EMA scientific committees and working parties, the European Centre for Disease Prevention and Control (ECDC), Health Technology Assessment bodies/payers and the European Commission.

All studies are published in the Catalogue of RWD studies.

Related information: Third RWE report | Infosheet - Review of real-world data studies | Real-world evidence | European Medicines Agency (EMA)