ICH Guidelines- Multidisciplinary Guidelines

ICH Multidisciplinary Guidelines:

Revised ICH Multidisciplinary Guidelines are listed below:

M1 MedDRA Terminology 

MedDRA Medical Dictionary for Regulatory Activities

M2 Electronic Standards 

ESTRI 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 R - Questions & Answers: Guidance on Non-Clinical 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 Genotoxic Impurities 

M7(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

M8 Electronic Common Technical Document (eCTD) 

Electronic Common Technical Document (eCTD)

M9 Biopharmaceutics Classification System-based Biowaivers 

M9 Biopharmaceutics Classification System-based Biowaivers

M10 Bioanalytical Method Validation 

M10 Bioanalytical Method Validation

Ref:

ICH Multidisciplinary Guidelines