Clinical efficacy and safety: general
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 Medicines Agency's scientific guidelines on the clinical safety and efficacy help medicine developers prepare marketing authorisation applications for human medicines
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
Guidelines
- Clinical development of fixed combination medicinal products
- Clinical evaluation of diagnostic agents
- Appendix 1 to the guideline on clinical evaluation of diagnostic agents on imaging agents
- Equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract
- Note for guidance on the clinical requirements for locally applied, locally acting products containing known constituents - First version
- Coordinating investigator signature of clinical study reports
- Guideline on registry-based studies
- ICH E1 Population exposure: the extent of population exposure to assess clinical safety
- ICH E2A Clinical safety data management: definitions and standards for expedited reporting
- ICH E2F Development safety update report
- ICH E3 Structure and content of clinical study reports
- ICH E4 Dose response information to support drug registration
- ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data
- ICH E5(R1) Ethnic factors in the acceptability of foreign clinical data - questions and answers
- ICH E6 Good clinical practice
- ICH E7 Studies in support of special populations: geriatrics
- ICH E7 Studies in support of special populations: geriatrics - questions and answers
- ICH E8 General considerations for clinical studies
- ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the pediatric population
- Inclusion of appendices to clinical study reports in marketing authorisation applications
- Investigation of chiral active substances
- Physical frailty: instruments for baseline characterisation of older populations in clinical trials
- Scientific guidance on post-authorisation efficacy studies
- ICH Q3D Elemental impurities
- Data Quality Framework for EU medicines regulation
Reflection papers
- Considerations given to designation of a single stereo isomeric form (enantiomer), a complex, a derivative, or a different salt or ester as new active substance in relation to the relevant reference active substance
- Establishing efficacy based on single-arm trials submitted as pivotal evidence in a marketing authorisation
- Extrapolation of results from clinical studies conducted outside Europe to the EU-population
- Regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products