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Announcement of NMPA on Recommended Application of 4 ICH Guidelines Including Q8 (R2): Pharmaceutical Development
    Pubtime: 2021-10-29

  On January 21, 2020, NMPA issued a notice on recommending the application of ICH Guideline Q8 (R2): Pharmaceutical Development, which reads as follows:

  To keep pace with the international technical standards for drug registration, NMPA has decided to recommend the application of 4 ICH Guidelines, including the Q8(R2): Pharmaceutical Development. The relevant matters are hereby announced as follows.

  1. From the date of issuance of this Announcement, applicants are recommended to follow ICH's Q8 (R2): Pharmaceutical Development, Q9: Quality Risk Management, Q10: Pharmaceutical Quality System, Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities) and Q & A documents.

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

  (January 22, 2020)

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