Volume 11 Issue 4
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Article Navigation >  Journal of Pharmaceutical Analysis  > 2021  >  11(4): 398-404
Xinyi Xu, Huayu Xu, Yue Shang, Ran Zhu, Xiaoxu Hong, Zonghua Song, Zhaopeng Yang. Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review[J]. Journal of Pharmaceutical Analysis, 2021, 11(4): 398-404. doi: 10.1016/j.jpha.2021.05.001
Citation: Xinyi Xu, Huayu Xu, Yue Shang, Ran Zhu, Xiaoxu Hong, Zonghua Song, Zhaopeng Yang. Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review[J]. Journal of Pharmaceutical Analysis, 2021, 11(4): 398-404. doi: 10.1016/j.jpha.2021.05.001
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Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review

doi: 10.1016/j.jpha.2021.05.001

  • Chinese Pharmacopoeia Commission, Beijing, 100061, China

Funds:

The authors acknowledge the financial support from the Chinese Pharmacopoeia Commission Drug Standard Promoting Funds and Comprehensive Reform of the Chinese Drug and Medical Device Review and Approval System Funds (2015–2020).

  • Received Date: Dec. 27, 2020
  • Accepted Date: May 09, 2021
  • Rev Recd Date: May 05, 2021
  • Available Online: Jan. 24, 2022
  • Publish Date: Aug. 15, 2021
    Abstract
  • The Chinese Pharmacopoeia 2020 edition was reviewed and approved by the National Medical Products Administration and the National Health Commission of the People's Republic of China in July 2020. The current edition was officially implemented on December 30, 2020. The general chapters of the Chinese Pharmacopoeia discuss the general testing methods and guidelines, which are the common requirements and basis for the implementation of drug standards in the Chinese Pharmacopoeia. Owing to adherence to the principles of scientificity, versatility, operability, and sustainable development, there is an improvement in the general chapters of the 2020 edition over those of the previous editions. Further, the application of advanced and mature analytical techniques has expanded, the development of testing methods for exogenous pollutants in traditional Chinese medicines has been strengthened, and technical requirements are now better harmonized with international standards. The updated edition provides technical and methodological support to ensure safety, effectiveness, and control of pharmaceuticals in China and will play an important and active role in encouraging the application of advanced technologies, improving the quality control of medicines, and strengthening the means of drug regulation in China. This review provides a comprehensive introduction of the main features of and changes to the general chapters in the Chinese Pharmacopoeia 2020 edition and aims to provide reference for its correct understanding and accurate implementation.
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