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.

Guidelines

• ICH M2 Electronic common technical document (eCTD) - file format criteria
• ICH M2 Electronic common technical document (eCTD)
• ICH M2 Business requirements
• ICH M3 (R2) Non-clinical safety studies for the conduct of human clinical trials for pharmaceuticals
• ICH M4 Common technical document (CTD) for the registration of pharmaceuticals for human use - organisation of CTD
• ICH M4 Common technical document for the registration of pharmaceuticals for human use: questions and answers
• ICH M4Q Common technical document for the registration of pharmaceuticals for human use - quality
• ICH M4Q Location issues for common technical document for the registration of pharmaceuticals for human use - quality: questions and answers
• ICH M4E Common technical document for the registration of pharmaceuticals for human use - efficacy
• ICH M4E Common technical document for the registration of pharmaceuticals for human use - efficacy: questions and answers
• ICH M4S Common technical document for the registration of pharmaceuticals for human use - safety
• ICH M4S Common technical document for the registration of pharmaceuticals for human use - safety: questions and answers
• ICH M5 Data elements and standards for drug dictionaries
• ICH M5 EWG Routes of administration controlled vocabulary
• ICH M5 EWG Units and measurements controlled vocabulary
• ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk
• ICH M8 Electronic common technical document (eCTD) v4.0 draft ICH implementation guide v2.0
• ICH M9 on biopharmaceutics classification system based biowaivers
• ICH M10 on bioanalytical method validation
• ICH M11 guideline, clinical study protocol template and technical specifications
• ICH M12 guideline on drug interaction studies
• ICH M13A guideline on bioequivalence for immediate-release solid oral dosage forms
• ICH M13B guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver
• ICH M14 guideline on general principles on plan, design and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines
• ICH M15 guideline on general principles for model-informed drug development - Step 2b