EMA publishes third annual report on the use of Real-World Evidence in the European Union (February 2024 – February 2025)

EMA publishes third annual report on the use of Real-World Evidence in the European Union (February 2024 – February 2025)

This report is part of the European Medicines Agency’s (EMA) systematic work to integrate Real-World Data (RWD) into regulatory decisions. 

It is being prepared as part of the European Regulatory Network (EMRN) strategy until 2028 and covers the experience of using three data collection and analysis channels:

• DARWIN EU® — a European network coordinated by EMA for the analysis of real-world data, combining information on more than 180 million patients from 16 countries
• Framework Contracts (FWC) — a mechanism for the rapid involvement of external scientific organizations
• Internal EMA studies

What's in the 2024–2025 report?

• 59 studies: 33 completed, 26 in progress (+47% compared to last year)
• Main areas: consumption of medicinal products, safety, epidemiology
• The average duration of a study in DARWIN EU is 4 months
• Implementation of new approaches to accelerated ethical review and data quality assessment

Who orders the studies?
The initiators are the EU regulatory and expert structures:

• PRAC (Pharmacovigilance Risk Assessment Committee) — safety signals
• CHMP (Committee for Medicinal Products for Human Use) — applications and strategies in geriatrics
• PDCO (Paediatric Committee) — pediatric studies
• COMP (Committee for Orphan Medicinal Products) — orphan diseases
• MSSG / SPOC (Medicines Shortages Steering Group / Single Point of Contact) — monitoring of shortages 
• VMP (Vaccine Monitoring Platform) — platform for monitoring the safety and efficacy of vaccines; 
• Agencies  Health Technology Assessment and Payers
• European Commission — through the HealthData@EU (EHDS) initiative

Most importantly — the report highlights specific cases where RWE played a key role in regulatory decisions:

• Investigation of suicide risk in patients taking glucagon-like peptide-1 (GLP-1) receptor agonists used in obesity and type 2 diabetes
• Monitoring of drug shortages
• Assessment of the efficacy and safety of the mpox (monkeypox) vaccine, including patients with HIV and immunosuppression
• Analysis of the epidemiology of respiratory syncytial virus (RSV) — to support expansion of the drug's indications to the age of 50–59 years
• Application of methods for emulating targeted clinical trials — for evaluating cancer drugs and vaccines in real clinical practice