China’s NMPA Announces Good Practices for Review Timelines During the Drug Evaluation Process


On November 2022, the NMPA CDE issued the Good Practice for Timing Termination and Restoration of Review in the Process of Drug Evaluation of NMPA (Trial Implementation)


This specification applies to registration applications of various drugs (including drug substances) and related applications of pharmaceutical excipients. Including drug marketing authorization applications, drug supplementary applications, import drug re-registration applications, consistency evaluation applications.

Specification applies For:

  • Registration applications of various drugs (including drug substances)
  • Related applications of pharmaceutical excipients
  • Pharmaceutical packaging materials

About Review Timing Suspension:

  • Refers to the suspension of the review task of drug registration application
  • The time used during the suspension period is not included in the review time limit.
  • Announces the specific circumstances for the execution of the suspension of the timings for review, and the specific operations for the suspension and resumption of the timing in each case.

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