Overview of the Updates to the 2025 Edition of the Chinese Pharmacopoeia (Volume I)
Year: 2026
Type: article
Abstract: The Pharmacopoeia of the People’s Republic of China (ChP) is the official compendium of drug standards issued by the Chinese government. Volume I, dedicated to traditional Chinese medicines (TCMs), serves as an authoritative standard for their production, testing, clinical application, and regulatory oversight. The ChP is updated every 5 years, and the current 2025 edition was officially implemented on October 1, 2025. Compared with the 2020 edition, the 2025 revision introduces substantial updates. This review summarizes the major additions and revisions to Volume I of the 2025 ChP across three sections: General Notices ; General Technical Requirements and Guidelines related to TCMs; and Monographs . Relative to the previous edition, the General Notices have undergone seven revisions. In the General Technical Requirements and Guidelines , three new items have been added, and five have been revised, with particular emphasis on strengthening safety controls for exogenous harmful substances, including pesticide residues, heavy metals and harmful elements, and mycotoxins. Regarding the Monographs , Volume I now includes 28 new entries, removes 19 previously listed entries, and revises 420 entries. The major updates involve refinements to fingerprint or characteristic chromatograms, assay methods, and test items. Collectively, the 2025 revision emphasizes enhanced safety requirements and improved standards for crude drugs and prepared slices, thereby strengthening the overall quality assurance framework for TCMs. This review aims to facilitate accurate interpretation and effective implementation of the 2025 edition of Volume I of the ChP.
Authors: Cui-Cui Wang, Rui-Qi Tang, Di Wu, Jian-Qing Zhang, De-An Guo
Language: English
Subfield: Complementary and alternative medicine
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7162073738