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).
ICH Multidisciplinary Guidelines from M1 to M14:
Click on the titles below for complete guidelines
M5 Data Elements and Standards for Drug Dictionaries
M8 Electronic Common Technical Document (eCTD)
M9 Biopharmaceutics Classification System-based Biowaivers
M10 Bioanalytical Method Validation
M11 Clinical electronic Structured Harmonised Protocol (CeSHarP)
M13 Bioequivalence for Immediate-Release Solid Oral Dosage Forms
M14 Use of real-world data in pharmacoepidemiological studies
ICH Multidisciplinary Guidelines from M1 to M14:
