Development of the general chapters of the Chinese Pharmacopoeia 2020 edition: A review
| Autor: | Huayu Xu, Yue Shang, Ran Zhu, Xiaoxu Hong, Xinyi Xu, Zonghua Song, Zhaopeng Yang |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Pharmaceutical Science
RM1-950 02 engineering and technology Pharmacy Commission Review Development 01 natural sciences Analytical Chemistry 2020 edition Drug Discovery Electrochemistry Chinese pharmacopoeia China Spectroscopy Sustainable development National health Review Paper Chemistry 010401 analytical chemistry General chapter 021001 nanoscience & nanotechnology Drug standards 0104 chemical sciences Engineering ethics Therapeutics. Pharmacology 0210 nano-technology |
| Zdroj: | Journal of Pharmaceutical Analysis Journal of Pharmaceutical Analysis, Vol 11, Iss 4, Pp 398-404 (2021) |
| ISSN: | 2214-0883 2095-1779 |
| Popis: | 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. Graphical abstract Image 1 Highlights • The additions and revisions of the Chinese Pharmacopoeia 2020 edition general chapters are introduced. • The applications of advanced techniques have been expanded in the Chinese Pharmacopoeia 2020 edition. • The technical requirements will be better harmonized with ICH in the Chinese Pharmacopoeia 2025 edition. |
| Databáze: | OpenAIRE |
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