The 2025 Edition of the Pharmacopoeia of the People's Republic of China (hereinafter referred to as the Chinese Pharmacopoeia) has been issued by Announcement No. 29, 2025 of the National Medical Products Administration and the National Health Commission and shall come into force as of October 01, 2025. The relevant matters concerning the implementation of this edition of the Chinese Pharmacopoeia are hereby announced as follows:

I. According to the provisions of the Drug Administration Law, drugs shall conform to the national drug standards. Chinese Pharmacopoeia constitutes an important part of the national drug standards and serves as a legal technical standard that should be followed by relevant institutions in drug R&D, production (import), distribution, use, supervision and administration.

II. Chinese Pharmacopoeia is primarily composed of General Notices, Monographs, General Technical Requirements and Guidelines. As of the date of implementation, all Marketing Authorization Holders (MAHs) and marketed drugs shall comply with the requirements of this announcement and the current edition of the Chinese Pharmacopoeia. Among these, the requirements outlined in the Guidelines are recommended technical requirements.

III. As of the date of implementation, for drug varieties that have been recorded in former editions of pharmacopoeias or in standards promulgated by CFDA or Ministry of Health (MOH), but now are included in this edition of the Chinese Pharmacopoeia, the corresponding former editions of pharmacopoeias and the standards promulgated by CFDA or MOH shall be abolished simultaneously; where those varieties are not recorded in this edition of the Chinese Pharmacopoeia, the corresponding former editions of pharmacopoeias and the standards promulgated by CFDA or MOH shall still prevail, but shall comply with the relevant general technical requirements of this edition of the Chinese Pharmacopoeia; for drug varieties revoked or cancelled after post-marketing evaluation, the corresponding former editions of pharmacopoeias and the standards promulgated by CFDA or MOH shall be abolished.

For preparation specifications and TCM preparation methods that are not recorded in the Monographs of this edition of the Chinese Pharmacopoeia, their quality standards shall comply with the requirements for the same kind of varieties specified in this edition of the Chinese Pharmacopoeia, while specifications and preparation methods shall comply with the original approval documents.

IV. After the issuance of this edition of the Chinese Pharmacopoeia, MAHs implementing drug registration standards shall promptly conduct relevant comparative studies to assess whether the drug registration standards meet the requirements of the new edition pharmacopoeia standards.

For any necessary change to drug registration standards, MAHs shall, prior to the implementation date of this edition of the Chinese Pharmacopoeia, submit supplementary applications, filings or reports in accordance with the relevant regulations on post-marketing management regulations and ensure compliance.

Where the test items recorded in drug registration standards outnumber or differ from those specified in the pharmacopoeia, or where the quality indicators are stricter than the pharmacopoeia requirements, the corresponding items and indicators of the registration standard shall be implemented simultaneously while requirements of the pharmacopoeia must also be met. Conversely, where the test items recorded in drug registration standards are fewer than those specified in the pharmacopoeia, or the quality indicators are lower than the pharmacopoeia requirements, the pharmacopoeia provisions shall prevail.

V. To comply with the requirements of this edition of the Chinese Pharmacopoeia, where changes in drug formulation, production processes, raw materials and excipients, or packaging materials/containers in direct contact with drugs are involved, MAHs and manufacturers shall conduct adequate research and validation in accordance with the requirements of the Provisions for Drug Registration, Provisions for Post-approval Changes of Drugs (Interim), relevant technical guidelines for change research, and the Good Manufacturing Practice for Drugs. Changes should be implemented following approval, filing, or reporting according to their classification.

VI. Due to the specificity of dissolution, release rate, and other items in quality control, if generic drug registration standards approved in accordance with the requirements of the consistency evaluation of the quality and efficacy of generic drugs differ from the Chinese Pharmacopoeia, the approved drug registration standards shall prevail.

VII. For drugs whose generic names have been revised in this edition of the Chinese Pharmacopoeia, the names specified in this edition of the Chinese Pharmacopoeia shall prevail, and their original names can be transitionally used as former names. Prior to the implementation date of the next edition of the Chinese Pharmacopoeia, the former names can be used simultaneously with the names specified in this edition of the Chinese Pharmacopoeia.

VIII. As of the date of implementation of this edition of Chinese Pharmacopoeia, the corresponding application dossiers for drug registration application shall comply with the relevant requirements of this edition of Chinese Pharmacopoeia.

For registration applications that have been accepted with pending technical review before the date of implementation of this edition of the Chinese Pharmacopoeia, the drug regulatory authority shall carry out corresponding review and approval according to the relevant requirements of this edition of the Chinese Pharmacopoeia, effective from the date of implementation of this edition of the Chinese Pharmacopoeia. Applicants who need to supplement technical information shall complete the supplement in a single submission.

Drugs approved for marketing according to the relevant requirements of previous pharmacopoeias after the date of issuance and before the date of implementation of this edition of the Chinese Pharmacopoeia shall comply with the relevant requirements of this edition of the Chinese Pharmacopoeia within 6 months after approval.

IX. Drug marketing authorization holders, manufacturers, and applicants for drug registration shall actively prepare for the implementation of this edition of the Chinese Pharmacopoeia, and promptly report any problems encountered in practice to the Chinese Pharmacopeia Commission, while continuously studying and improving drug quality standards to persistently improve the level of drug quality control.

X. All provincial drug regulatory authorities shall cooperate in the publicity and implementation of this edition of Chinese Pharmacopoeia, reinforce the supervision and guidance during its implementation, and promptly collect and provide feedback on related issues and opinions.

XI. The Chinese Pharmacopeia Commission is responsible for organizing and coordinating the publicity, implementation, training and technical guidance of this edition of Chinese Pharmacopoeia, opening up the Chinese Pharmacopoeia Implementation Column on its official website, and in a timely manner, answering questions reflected during implementation.

It is hereby announced.

National Medical Products Administration

March 25, 2025