This guideline presents the agreed upon common format for the preparation of a well-structured Common Technical Document (CTD) for applications that will be submitted to regulatory authorities. The document primarily addresses the organisation of the information to be presented in registration applications for new pharmaceuticals (including biotechnology-derived products).<\/p>\n
Module 1 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 \u2018quality\u2019 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.<\/p>\n
The Common Technical Document was agreed upon in November 2000 and re-edited with Numbering and Section Headers changes in September 2002.<\/p>\n
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.<\/p>\n","protected":false},"excerpt":{"rendered":"
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