Real-world evidence
HumanRegulatory and procedural guidanceResearch and developmentScientific guidelines
On Monday, 12 January 2026, between 07:00 and 10:00 CET (Amsterdam time), this website will be unavailable due to scheduled maintenance.
The European Medicine Agency's (EMA) scientific guidelines on real-world evidence aim support the use of real-world data in regulatory decision-making.
For a complete list of scientific guidelines currently open for consultation, see Public consultations.