ICH: multidisciplinary
The European Medicines Agency publishes scientific guidelines on human medicines that are harmonised by the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).
For a complete list of scientific guidelines currently open for consultation, see Public consultations.
- ICH M2 Electronic common technical document (eCTD) - file format criteria - Scientific guideline
- ICH M2 Electronic common technical document (eCTD) - Scientific guideline
- ICH M2 Business requirements - Scientific guideline
- ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals - Scientific guideline
- ICH M4 Common technical document (CTD) for the registration of pharmaceuticals for human use - organisation of CTD - Scientific guideline
- ICH M4 Common technical document for the registration of pharmaceuticals for human use: questions and answers - Scientific guideline
- ICH M4Q Common technical document for the registration of pharmaceuticals for human use - quality - Scientific guideline
- ICH M4Q Location issues for common technical document for the registration of pharmaceuticals for human use - quality: questions and answers - Scientific guideline
- ICH M4E Common technical document for the registration of pharmaceuticals for human use - efficacy - Scientific guideline
- ICH M4E Common technical document for the registration of pharmaceuticals for human use - efficacy: questions and answers - Scientific guideline
- ICH M4S Common technical document for the registration of pharmaceuticals for human use - safety - Scientific guideline
- ICH M4S Common technical document for the registration of pharmaceuticals for human use - safety: questions and answers - Scientific guideline
- ICH M5 Data elements and standards for drug dictionaries - Scientific guideline
- ICH M5 EWG Routes of administration controlled vocabulary - Scientific guideline
- ICH M5 EWG Units and measurements controlled vocabulary - Scientific guideline
- ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - Scientific guideline
- ICH M8 Electronic common technical document (eCTD) v4.0 draft ICH implementation guide v2.0 - Scientific guideline
- ICH M9 on biopharmaceutics classification system based biowaivers - Scientific guideline
- ICH M10 on bioanalytical method validation - Scientific guideline
- ICH M11 guideline, clinical study protocol template and technical specifications - Scientific guideline
- ICH M12 on drug interaction studies - Scientific guideline
- ICH guideline M13A on bioequivalence for immediate-release solid oral dosage forms ICH Guideline M13A on bioequivalence for immediate-release solid oral dosage forms - Scientific guideline