ICH Multidisciplinary Guidelines

ICH Multidisciplinary Guidelines

Those are the cross-cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories.  It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

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

M4 Common Technical Document:

CTD: The Common Technical Document MS 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(R2)Maintenance EWC/IWG Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Pisk

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 EWC/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 EWC 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

Source from ICH