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Thursday, July 20, 2023 11:21:52 AM
I also don't think the number of modules would be any less, based on any “new pathways” in any particular country. The regulatory requirements for approval shouldn't really be any less rigorous, even if the regulatory process is accelerated.
And yes, it does sound to me as though the MHRA may create a new, accelerated pathway for cancer vaccines, perhaps from development through approval.
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 revolutionised the regulatory review processes, led to harmonised 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 organised 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.
https://www.ich.org/page/ctd
CTD Triangle
https://admin.ich.org/sites/default/files/2021-02/CTD_triangle_color_Proofread.pdf
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