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
Monographs of traditional Chinese medicines (TCMs)
Monographs of chemical drugs
General monographs of biological products
General requirements for biological products
Monographs of biological products
General requirements for preparations
General testing methods and other general chapters
Monographs of pharmaceutical excipients
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
Newly added monographs of TCMs
Revised monographs of TCMs
Newly added monographs of chemical drugs
Revised monographs of chemical drugs
Revised general monographs of biological products
Revised general requirements for biological products
Revised monographs of biological products
Newly added general chapters and guidelines for biological products
Revised general chapters and guidelines for biological products
Newly added guidelines
Revised general chapters and guidelines
Newly added monographs of excipients
Revised monographs of excipients
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