• M4(R4): Organisation

    Finalised Guideline: June 2016

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

    The overall organisation of the CTD is presented here.

    The CTD is organised into five modules:

    Module1 is for administrative information and prescribing information, and should contain documents that are specific to each region; for example, application forms or the proposed label for use in the region. Module 2 contains the CTD summaries and should begin with a general introduction to the drug, including its pharmacological class, mode of action and proposed clinical use. Module 2 should also provide the overall summary of the ‘quality’ information provided, the non-clinical overview and the clinical overview, as well as the non-clinical written summaries and the tabulated summaries, and the clinical summary. As a foundation for the aforementioned material, module 3 contains information on quality topics, module 4 contains the nonclinical study reports and module 5 contains the clinical study reports.
    The organisation of summaries in module 2 is described in Guidelines for M4Q, M4S, M4E.

    The Common Technical Document was agreed upon in November 2000 and re-edited with Numbering and Section Headers changes, September 2002.

    The Granularity Document in Annex was included in 2002, and further corrected in 2003 and 2004. In 2016, this Annex was revised to add Module 2 and 3 tables and Appendices for eCTD v4, as well as, corrections to Module 2 and 3 tables for eCTD v3.2.2.

    Implementation :

    Step 5

    :

    EC, EuropeTo be notified

    FDA, US - Published in the federal register 3 October 2017, Vol. 82, No. 190 p. 46078-46079

    Health Canada, Canada To be notified

    MHLW/PMDA, Japan To be notified

    Swissmedic, Switzerland - Refer to the press release on Swissmedic, Switzerland's website

    M4 Q&As Document (R3)

    Finalised Q&As:
    June 2004

    In order to help users deal with issues which may arise during attempts to use the CTD, the ICH has supplied a Questions & Answers section on the ICH web site to answer most, if not all, questions anyone may have. If issues arise that are not answered on the web site, additional questions can be submitted for a formal response.

    Implementation :

    Step 5

    :

    EC, EuropeReleased for information as CHMP/ICH/5552/02, June 2004.

    :

    MHLW/PMDA, Japan Adopted 24 November 2004, PFSB/ELD Notification

    :

    FDA, US Posted on the FDA website 22 December 2004

    :

    Health Canada, Canada - to be notified

    :

    Swissmedic, Switzerland - Refer to the press release on Swissmedic, Switzerland's website