Editor’s notes: The Pharmacopoeia of the People’s Republic of China, also known as Chinese Pharmacopoeia, is a collection of drug standards in China.
On October 12, 2023, China’s National Medical Products Administration (NMPA) and National Health Commission (NHC) jointly announced the release of the first Addendum to the Chinese Pharmacopoeia 2020 Edition.
The authorities disclosed the contents of the Addendum, but did not provide the main texts. It was stated that the Addendum has been compiled and is planned to be implemented on March 12, 2024.
The Chinese Pharmacopoeia 2020 Edition constitutes four volumes:
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 | ||
The Addendum includes 54 additions and 607 revisions, which are encapsulated in Table 2:
Table 2: Additions and Revisions in the First Addendum to the Chinese Pharmacopoeia 2020 Edition
Volume | Content | Number |
Volume I | Newly added monographs of TCMs | 9 |
Revised monographs of TCMs | 94 | |
Volume II | Newly added monographs of chemical drugs | 28 |
Revised monographs of chemical drugs | 407 | |
Volume III | Revised general monographs of biological products | 2 |
Revised general requirements for biological products | 1 | |
Revised monographs of biological products | 45 | |
Newly added general chapters and guidelines for biological products | 5 | |
Revised general chapters and guidelines for biological products | 4 | |
Volume IV | Newly added guidelines | 1 |
Revised general chapters and guidelines | 8 | |
Newly added monographs of excipients | 11 | |
Revised monographs of excipients | 46 |
If you are interested in learning more about China's drug standards or getting access to the English version of the Chinese Pharmacopoeia, please feel free to reach out to us. We would be happy to provide you with further information and assist you in obtaining the resources you need.
