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NMPA Released Announcement on the Application of 13 ICH Guidelines Including S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals
    Pubtime: 2021-10-29

  On November 12, 2019, NMPA issued the Announcement on the Application of 13 ICH Guidelines Including S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals, which reads as follows:

  To keep pace with the international technical standards for drug registration, NMPA has decided after research to apply 13 ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) guidelines, including the S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals. The relevant matters are announced as follows:

  1. Applicants must conduct research in accordance with the ICH Guidelines ASAP based on the current technical requirements; as from May 1, 2020, non-clinical studies (with start dates determined pursuant to the Good Laboratory Practice for Non-Clinical Laboratory Studies) shall apply to 13 ICH non-clinical guidelines.

  2. Relevant technical guidelines can be found on the website of Center for Drug Evaluation, NMPA, who is responsible for related technical guidance in the implementation of this Announcement.

  (November 12, 2019)

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