China Profile Updated in ClinRegs
October 28, 2021

The China profile in ClinRegs has been reviewed and updated with the following information:

Sources Added During this Update:

  • (Guidance) Guidelines for the Construction of Ethical Review Committees for Clinical Research Involving People (EC-Guide – Standard Chinese) (October 2020)
    Office of Medical Ethics Expert Committee of the National Health Commission and the Chinese Hospital Association
  • (Guidance) Guiding Principles for the Adaptive Design of Drug Clinical Trials (No. 6 of 2021) (NMPA-No6-2021 – Standard Chinese) (GoogleTranslate-NMPA-No6-2021) (January 29, 2021)
    National Medical Products Administration, State Administration for Market Regulation
  • (Guidance) Guiding Principles for the Multiplicity of Drug Clinical Trials (No. 66 of 2020) (NMPA-No66-2021 – Standard Chinese) (GoogleTranslate-NMPA-No66-2021) (December 31, 2020)
    National Medical Products Administration, State Administration for Market Regulation
  • (Guidance) Technical Guidelines for Clinical Trials of Improved New Chemical Drugs (No. 54 of 2020) (NMPA-No54-2020 – Standard Chinese) (GoogleTranslate-NMPA-No54-2020)  (December 31, 2020)
    National Medical Products Administration, State Administration for Market Regulation
  • (Guidance) Technical Guidelines for Pharmaceutical Changes During Clinical Trials of Innovative Drugs (No. 22 of 2021) (NMPA-No22-2021 – Standard Chinese) (GoogleTranslate-NMPA-No22-2021) (March 12, 2021)
    National Medical Products Administration, State Administration for Market Regulation
  • (Legislation) Data Security Law of the People’s Republic of China (DataScrty) (Effective September 1, 2021)
    National People’s Congress
  • (Legislation) Personal Information Protection Law of the People’s Republic of China (PIPL) (Effective November 1, 2021)
    National People’s Congress
  • (Regulation) Information Security Technology Health and Medical Data Security Guidelines (DataScrty-Stds) (Effective July 1, 2021)
    National Information Security Standardization Technical Committee
  • (Regulation) Management Measures for Communication and Exchange of Drug R&D and Technical Review (No. 48 of 2020) (NMPA-No48-2020) (GoogleTranslate-NMPA-No48-2018) (December 10, 2020)
    National Medical Products Administration, State Administration for Market Regulation
  • (Regulation) Pharmacological Vigilance Quality Management Standards (No. 65 of 2021) (NMPA-No65-2021) (May 7, 2021)
    National Medical Products Administration, State Administration for Market Regulation
  • (Regulation) Technical Requirements for Evaluation of Chemical Drugs Marketed Overseas But Not Marketed in China (No. 21 of 2021) (NMPA-No21-2021 – Standard Chinese) (GoogleTranslate-NMPA-No21-2021) (March 8, 2021)
    National Medical Products Administration, State Administration for Market Regulation
  • (Article) China Passes Personal Information Protection Law (CHN-25) (September 10, 2021)
    Ropes & Gray
  • (Article) In Review: The Life Sciences Regulatory Regime in China (CHN-20) (March 24, 2021)
    Covington & Burling
  • (Article) Why Conduct Clinical Trials in China? A Regulatory Perspective (CHN-17) (April 2, 2021)
    CR Medicon
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