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NMPA Issued Announcement on Releasing M4: Common Technical Document (CTD) for the Registration of Pharmaceuticals for Human Use (CTD) Module 1 and its Chinese Translation
    Pubtime: 2021-10-29

  As per the relevant provisions of the former CFDA's Announcement on Applying the ICH Secondary Guidelines (No. 10 of 2018) (hereinafter referred to as Announcement No. 10 of 2018), NMPA organized the formulation of and released on April 17, 2019 the Module 1: Administrative Information and Prescribing Information of M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use (hereinafter referred to as M4). As from July 1, 2019, the applicant shall submit dossiers in alignment with the Module 1. Requirements for registration application of drugs meeting conditions stipulated in the Announcement No. 10 of 2018.

  Meanwhile, a Chinese version of the full text of the M4 Guidelines, the translation of which being organized by NMPA, was also released.

  (April 17, 2019)

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