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
- 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
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Clinical requirements for locally applied, locally acting products containing known constituents
- Coordinating investigator signature of clinical study reports
- 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 (R2) 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 (human)
- Physical frailty: instruments for baseline characterisation of older populations in clinical trials
- Scientific guidance on post-authorisation efficacy studies
- ICH Q3D Elemental impurities
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
- 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
Position papers
Concept papers