PharmD Info

This topic ICH Guidelines - Multidicplinary covers the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI).

List of ICH Guidelines - Multidicplinary Topics

M1 MedDRA - Medical Dictionary for Regulatory Activities

M1 PtC WG MedDRA Points to Consider

M10 EWG Bioanalytical Method Validation

M11 EWG Clinical electronic Structured Harmonised Protocol (CeSHarP)

M12 EWG Drug Interaction Studies 

M13 EWG Bioequivalence for Immediate-Release Solid Oral Dosage Forms

M2 EWG Electronic Standards for the Transfer of Regulatory Information

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 Q&As (R3) Questions & Answers: Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

M4(R4) Organisation Including the Granularity document that provides guidance on document location and paginations

M4E Q&As (R4) Questions & Answers: CTD on Efficacy

M4E(R2) CTD on Efficacy

M4Q Q&As (R1) Questions & Answers: CTD on Quality

M4Q(R1) CTD on Quality

M4Q(R1) IWG Quality

M4S Q&As (R2) Questions & Answers: CTD on Safety

M4S(R2) CTD on Safety

M5 Data Elements and Standards for Drug Dictionaries

M6 Virus and Gene Therapy Vector Shedding and Transmission

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

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

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