China Profile Updated to Include New NMPA Guidelines

April 6, 2023
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The China profile in ClinRegs has been updated to include the following guidelines issued by the National Medical Products Administration (NMPA) in March 2023:

  • New guidance regarding the Phase III pre-clinical trial meeting with the Center for Drug Evaluation when researching innovative drugs (See Submission Process)
  • New guidelines related to the summary, analysis, and reporting of safety information (See Safety Reporting)
  • Updated frequently asked questions and answers regarding the rapid reporting of safety data (See Safety Reporting)
  • Technical guidelines concerning clinical trials of chemical compound drugs (See Risk & Quality Management)

Additionally, a 2019 guideline on classifying AEs in clinical trials of investigational vaccines was added (See Safety Reporting).

Sources Added During this Update:

(Guidance) Frequently Asked Questions and Answers on Rapid Reporting of Safety Data During Drug Clinical Trials (Version 2.0) (NMPA-No17-2023 – Standard Chinese) (March 17, 2023)
National Medical Products Administration, State Administration for Market Regulation

(Guidance) Guidelines for the Summary, Analysis, and Reporting of Safety Information During Drug Clinical Trials (NMPA-No16-2023 – Standard Chinese) (March 17, 2023)
National Medical Products Administration, State Administration for Market Regulation

(Guidance) Common Issues in Pharmacy and Related Technical Requirements of the Pre-Clinical Conference of Phase III Clinical Trials for Innovative Chemical Drugs (NMPA-No23-2023 – Standard Chinese) (March 22, 2023)
National Medical Products Administration, State Administration for Market Regulation

(Guidance) Technical Guidelines for Clinical Trials of Chemical Compound Drugs (NMPA-No15-2023 – Standard Chinese) (March 17, 2023)
National Medical Products Administration, State Administration for Market Regulation

(Guidance) Guidelines for Classifying Adverse Events in Clinical Trials of Preventive Vaccines (NMPA-No102-2019 – Standard Chinese) (December 31, 2019)
National Medical Products Administration, State Administration for Market Regulation

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