Drugs

International Council for Harmonisation - Joint Safety/Efficacy (Multidisciplinary)

Below is a sortable list of the International Council on Harmonisation - Multidisciplinary Guidance Documents. You can sort alphabetically by: Category/Subject Area; Guidance Title; Guidance Type (Draft or Final) and also sort by the Date the Guidance was issued.

Note: M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use

International Conference on Harmonisation has changed its name to International Council for Harmonisation

CategoryTitleTypeDate
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M2 eCTD: Electronic Common Technical Document Specification (PDF - 1020KB) Final Guidance 04/01/03
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M2: eCTD Specification Questions and Answers and Change Requests (PDF - 31KB) Final Guidance 03/14/05
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M2: eCTD Specification Questions & Answers and Change Requests Companion Document Final Guidance 06/03/13
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (PDF - 325KB) Final Guidance 01/20/10
International Council on Harmonisation - Multidisciplinary M3(R2)Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals: Questions and Answers (PDF - 311KB) Final Guidance 02/25/13
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M4: Organization of the CTD (PDF - 31KB) Final Guidance 08/01/01
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M4 Granularity Annex (PDF - 124KB) Final Guidance 10/01/05
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M4: The CTD -- General Questions and Answers (PDF - 45KB) Final Guidance 12/22/04
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M4: The CTD -- Quality (PDF - 131KB) Final Guidance 08/01/01
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M4: The CTD -- Quality Questions and Answers /Location Issues (PDF - 86KB) Final Guidance 06/08/04
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M4: The CTD -- Efficacy (PDF - 286KB) Final Guidance 08/01/01
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M4: The CTD -- Efficacy Questions and Answers (PDF - 165KB) Final Guidance 12/01/04
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M4S: The CTD -- Safety (PDF - 116KB) Final Guidance 08/01/01
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M4S: The CTD -- Safety Appendices (PDF - 2MB) Final Guidance 08/01/01
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M4: The CTD -- Safety Questions and Answers (PDF - 27KB) Final Guidance 02/04/03
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M5International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries (PDF - 406KB) Draft Guidance 09/01/05
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) Submitting Marketing Applications According to the ICH/CTD Format: General Considerations (PDF - 175KB) Draft Guidance 09/01/01
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk (PDF - 260KB) Final Guidance 05/27/15
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M8 Electronic Common Technical Document (eCTD) v4.0 DRAFT Implementation Guide v2.0; and eCTD Implementation Package DRAFT Specification for Submission Formats v2.0 Draft Guidance 04/22/15
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Application of the Principles of the ICH M7 Guidance to Calculation of Compound-Specific Acceptable Intakes (PDF - 729KB) Draft Guidance 09/25/15
International Council on Harmonisation - Joint Safety/Efficacy (Multidisciplinary) M4E(R2): The CTD – Efficacy (PDF - 492KB) Draft Guidance 10/01/15

Page Last Updated: 08/16/2016
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