New Requirements Issued by China's NMPA
August 6, 2020

China’s National Medical Products Administration (NMPA) has updated their website, which has resulted in a number of broken links in the China country profile. The ClinRegs team is working to identify and replace these links.

In addition, the NMPA has recently released the following requirements, which the ClinRegs team is reviewing and will incorporate into the China profile this year.

  • Registration Classification and Application Information Requirements for Biological Products (No. 43 of 2020) (NMPA-No43-2020 – Standard Chinese) (Effective July 1, 2020 (registration) and October 1, 2020 (application))
  • Guidelines for the Preservation of Essential Documents for Drug Clinical Trials (No. 37 of 2020) (NMPA-No37-2020 – Standard Chinese) (Effective July 1, 2020)
  • Quality Management Practices for Drug Clinical Trials (No. 57 of 2020) (NMPA-GCP-No57-2020 – Standard Chinese) (Effective July 1, 2020)
  • Measures for the Supervision and Administration of Drug Production (No. 28 of 2020) (NMPA-No28-2020 – Standard Chinese) (Effective July 1, 2020)
  • Working Procedures for Review of Breakthrough Therapeutics (No. 82 of 2020) (NMPA-No82-2020 – Standard Chinese) (Effective July 8, 2020)
  • Guidelines for Submission of Drug Clinical Trial Data (No. 16 of 2020) (NMPA-No16-2020 – Standard Chinese) (Effective October 1, 2020)
  • Requirements for Drug Records and Data Management for Trial Implementation (No. 74 of 2020) (NMPA-No74-2020 – Standard Chinese) (Effective December 1, 2020)

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

Use the symbols below to refine your search
SymbolExplanation
No symbol At least one of the keywords must be present
Search example: serious adverse event
Result: Will contain serious and/or adverse and/or event
+ Leading plus sign indicates that the word must be present
Search example: serious +adverse event
Result: Will contain adverse and may contain serious and/or event
- Leading minus sign indicates that the word must not be present
Search example: serious adverse -event
Result: Will contain serious and/or adverse but won’t contain event
“ ” Exact phrase must be present
Search example: “serious adverse event”
Result: Will contain the phrase serious adverse event
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