On Jul. 2, 2020, the National Medical Product Administration (NMPA) and the National Health Commission (NHC) published the 2020 Edition of the Pharmacopoeia of the People's Republic of China (hereinafter referred to as Chinese Pharmacopoeia), which came into force on Dec. 30, 2020.
All finished pharmaceutical products with China's marketing authorization shall meet the technical requirements of dosage forms, test methods, guidelines, etc., in the Chinese Pharmacopoeia since Dec. 30, 2020.
Chinese Pharmacopoeia is a collection of standards for drug development, production, sales, utilization, supervision, and control in China. The 2020 edition is the 11th edition of Chinese Pharmacopoeia, covering 5,911 monographs of traditional Chinese medicines, chemical drugs, biologics, and pharmaceutical excipients.
Chinese Pharmacopoeia 2020 Edition | |||
Volume | Category | Number | |
Volume I | Traditional Chinese medicine (TCM) monographs | 2,711 | |
Volume II | Chemical drug (including active chemical substance) monographs | 2,712 | |
Volume III | Biologic product monographs | 153 | |
Volume IV | General chapters | General requirements for preparations | 38 |
Testing methods and other requirements | 281 | ||
Guidelines | 42 | ||
Pharmaceutical excipient monographs | 335 | ||
Chinese Pharmacopoeia 2020 English Version has been available since Mar. 14, 2023. Contact BaiPharm if you'd like to get access to the English version.
