ICH M4 Common Technical Document Guidelines


M4 Common Technical Document

CTD: The Common Technical Document

The Common Technical Document was agreed upon by the Steering Committee in November 2000. Due to the development of this topic over the years, all information about the CTD are available on the CTD page under the Work Products.

M4 : The Common Technical Document

The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionized the regulatory review processes, led to harmonized electronic submission that, in turn, enabled implementation of good review practices. For industries, it has eliminated the need to reformat the information for submission to the different ICH regulatory authorities.

The CTD is organized into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. In July 2003, the CTD became the mandatory format for new drug applications in the EU and Japan, and the strongly recommended format of choice for NDAs submitted to FDA, United States.

CTD Triangle

*These Guidelines Belongs to ICH website.

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