ICH MULTIDISCIPLINARY GUIDELINES

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M1 MedDRA Terminology

M1: MedDRA- Medical Dictionary for Regulatory Activities

M1: PtC WG MedDRA Points to Consider

M2 Electronic Standards

M2: EWG Electronic Standards for the Transfer of Regulatory Information

M3 Nonclinical Safety Studies

M3(R2): Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

M3(R2) Q&As (R2): Questions & Answers: Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

M4 Common Technical Document

CTD: The Common Technical Document

M5 Data Elements and Standards for Drug Dictionaries

M5: Data Elements and Standards for Drug Dictionaries

M6 Gene Therapy

M6: Virus and Gene Therapy Vector Shedding and Transmission

M7 Mutagenic impurities

M7(R1): Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
M7(R2): Maintenance EWG/IWG Assessment and Control of DNA Reactive (Mutagenic) impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

M7(R2): Q&As Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

M8 Electronic Common Technical Document (eCTD)

M8: eCTD v3.2.2 Electronic Common Technical Document (eCTD) v3.2.2

M8: eCTD v4.0 Electronic Common Technical Document (eCTD) v4.0

M8: EWG/IWG Electronic Common Technical Document (eCTD)

M9 Biopharmaceutics Classification System-based Biowaivers

M9: Biopharmaceutics Classification System-based Biowaivers

M9 Q&As: Q&As on Biopharmaceutics Classification System-based Biowaivers

M10 Bioanalytical Method Validation and Study Sample Analysis

M10 EWG: Bioanalytical Method Validation and Study Sample Analysis

M10 Q&As: Questions and Answers: Bioanalytical Method Validation and Study Sample Analysis

M11 Clinical electronic Structured Harmonised Protocol (CeSHarP)

M11 EWG: Clinical electronic Structured Harmonised Protocol (CeSHarP)

M12 Drug Interaction Studies

M12 EWG: Drug Interaction Studies

M13 Bioequivalence for Immediate-Release Solid Oral Dosage Forms

M13 EWG: Bioequivalence for Immediate-Release Solid Oral Dosage Forms

M14 Use of real-world data for safety assessment of medicines

M14 EWG: General principles on plan, design, and analysis of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines

M15 General Principles for Model-Informed Drug Development

M15 EWG: General Principles for Model-Informed Drug Development

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