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

Note: M4: M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use Guidance for Industry.  This guidance replaces two FDA guidance documents, the 2001 guidance for industry M4 Organization of the CTD and the 2005 Granularity Document Annex to M4 Organization of the CTD. This merger reflects the 2002 addition of the Annex: Granularity Document into the Organization of the 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 Common Technical Document for the Registration of Pharmaceuticals for Human Use Guidance for Industry (PDF - 269KB) Final Guidance 10/03/17
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(R1) Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk (PDF - 1.4MB) Final Guidance 03/13/18
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) M4E(R2): The CTD – Efficacy (PDF - 470KB) Final Guidance Revision 1 07/24/17
ICH – Multidisciplinary M9 Biopharmaceutics Classification System-Based Biowaivers (PDF - 460KB) Draft Guidance 10/25/18

Page Last Updated: 10/25/2018
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