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
