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.
Table 1: Volumes of Chinese Pharmacopoeia 2020 Edition
Volume | Content | Number | |
Volume I | Monographs of traditional Chinese medicines (TCMs) | 2,711 | |
Volume II | Monographs of chemical drugs | 2,712 | |
Volume III | General monographs of biological products | 8 | |
General requirements for biological products | 8 | ||
Monographs of biological products | 153 | ||
Volume IV | General chapters | General requirements for preparations | 38 |
General testing methods and other general chapters | 281 | ||
Guidelines | 42 | ||
Monographs of pharmaceutical excipients | 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.
