New Requirements Issued by China's NMPA

August 18, 2020
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China’s National Medical Products Administration (NMPA) has recently released the following requirements, which the ClinRegs team is reviewing and will incorporate into the China profile this year.

  • Drug Clinical Trial Registration and Information Disclosure Management (No. 9 of 2020) (NMPA-No9-2020 – Standard Chinese) (Effective July 1, 2020)

  • Safety Information Evaluation and Management During Drug Clinical Trials (No. 5 of 2020) (NMPA-No5-2020 – Standard Chinese) (Effective July 1, 2020)

  • Management of Safety Update Reports During R&D (No. 7 of 2020) (NMPA-No7-2020 – Standard Chinese) (Effective July 1, 2020)

For details on all of China’s clinical research regulatory requirements, view the China country profile.

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