Clinical efficacy and safety: general
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 - Scientific guideline
- Clinical evaluation of diagnostic agents - Scientific guideline
- Appendix 1 to the guideline on clinical evaluation of diagnostic agents on imaging agents - Scientific guideline
- Equivalence studies for the demonstration of therapeutic equivalence for locally applied, locally acting products in the gastrointestinal tract - Scientific guideline
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Clinical requirements for locally applied, locally acting products containing known constituents
- Coordinating investigator signature of clinical study reports - Scientific guideline
- Guideline on registry-based studies - Scientific guideline
- ICH E1 Population exposure: the extent of population exposure to assess clinical safety - Scientific guideline
- ICH E2A Clinical safety data management: definitions and standards for expedited reporting - Scientific guideline
- ICH E2F Development safety update report - Scientific guideline
- ICH E3 Structure and content of clinical study reports - Scientific guideline
- ICH E4 Dose response information to support drug registration - Scientific guideline
- ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data - Scientific guideline
- ICH E5(R1) Ethnic factors in the acceptability of foreign clinical data - questions and answers - Scientific guideline
- ICH E6 (R2) Good clinical practice - Scientific guideline
- ICH E7 Studies in support of special populations: geriatrics - Scientific guideline
- ICH E7 Studies in support of special populations: geriatrics - questions and answers - Scientific guideline
- ICH E8 General considerations for clinical studies - Scientific guideline
- ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the pediatric population - Scientific guideline
- Inclusion of appendices to clinical study reports in marketing authorisation applications - Scientific guideline
- Investigation of chiral active substances (human) - Scientific guideline
- Physical frailty: instruments for baseline characterisation of older populations in clinical trials - Scientific guideline
- Scientific guidance on post-authorisation efficacy studies - Scientific guideline
- ICH Q3D Elemental impurities - Scientific guideline
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 - Scientific guideline
- Extrapolation of results from clinical studies conducted outside Europe to the EU-population - Scientific guideline
- Regulatory guidance for the use of health-related quality of life (HRQL) measures in the evaluation of medicinal products - Scientific guideline
Position papers
Concept papers