The 2025 edition of the Pharmacopoeia of the People's Republic of China (hereinafter referred to as the "Chinese Pharmacopoeia") has been promulgated by the National Medical Products Administration and the National Health Commission in Announcement No. 29 of 2025, and will be implemented from October 1, 2025. The relevant matters regarding the implementation of this version of the Chinese Pharmacopoeia are hereby announced as follows:

1、 According to the Drug Administration Law, drugs should comply with national drug standards. The Chinese Pharmacopoeia is an important component of national drug standards and a legal technical standard that should be followed by drug development, production (import), operation, use, and supervision and management units.

2、 The Chinese Pharmacopoeia mainly includes specifications, variety texts, general technical requirements, and guiding principles. From the date of implementation, all drug marketing authorization holders and drugs produced and marketed shall comply with the relevant requirements of this announcement and this version of the Chinese Pharmacopoeia. Among them, the relevant requirements of the guiding principles are recommended technical requirements.

3、 From the date of implementation, all varieties originally included in previous editions of pharmacopoeias and standards issued by bureaus (departments) that are included in this edition of the Chinese Pharmacopoeia shall be simultaneously abolished; For those not included in this edition of the Chinese Pharmacopoeia, the corresponding previous editions of the Pharmacopoeia and standards issued by bureaus (departments) shall still be implemented, but they shall comply with the relevant general technical requirements of this edition of the Chinese Pharmacopoeia. Varieties that have been evaluated and revoked or cancelled after listing shall have their corresponding editions of pharmacopoeias and standards issued by bureaus (departments) abolished.

The quality standards for the specifications of formulations and the preparation methods of traditional Chinese medicine that are not included in the main text of this edition of the Chinese Pharmacopoeia shall be implemented in accordance with the relevant requirements of the same variety in this edition of the Chinese Pharmacopoeia. The specifications and preparation methods shall be implemented in accordance with the original approval certificate documents.

4、 After the promulgation of this version of the Chinese Pharmacopoeia, if the drug registration standards are implemented, the holder of the drug marketing authorization shall promptly conduct relevant comparative research to evaluate whether the drug registration standards meet the requirements of the newly promulgated pharmacopoeia standards.

For those who need to change the drug registration standards, the holder of the drug marketing authorization shall submit a supplementary application, filing or report in accordance with the relevant regulations on post marketing change management before the implementation of this version of the Chinese Pharmacopoeia, and execute it as required.

If the inspection items included in the drug registration standards are more or different from those specified in the pharmacopoeia, or if the quality indicators are stricter than those required by the pharmacopoeia, the corresponding items and indicators of the registration standards should be implemented on the basis of implementing the pharmacopoeia requirements. If the inspection items included in the drug registration standards are less than those specified in the pharmacopoeia or the quality indicators are lower than those required by the pharmacopoeia, the pharmacopoeia regulations shall be followed.

5、 In order to comply with the requirements of this edition of the Chinese Pharmacopoeia, if there are changes to drug prescriptions, production processes, raw materials, excipients, packaging materials and containers that directly come into contact with drugs, the holder of drug marketing authorization and the production enterprise shall conduct sufficient research and verification in accordance with the "Measures for the Administration of Drug Registration", "Measures for the Administration of Changes after Drug Marketing (Trial)", as well as relevant technical guidance principles for change research and drug production quality management standards, and implement or report according to the corresponding change categories after approval and filing.

6、 Due to the special nature of dissolution and release in quality control, if the approved generic drug registration standards differ from the Chinese Pharmacopoeia in terms of quality and efficacy consistency evaluation requirements, the approved drug registration standards shall be followed.

7、 For drugs whose generic names have been revised in this version of the Chinese Pharmacopoeia, the names specified in this version of the Chinese Pharmacopoeia should be used, and their original names can be used as transitional names. Prior to the implementation of the next edition of the Pharmacopoeia, previously used names may be used simultaneously with the names listed in this edition of the Chinese Pharmacopoeia.

8、 From the implementation date of this version of the Chinese Pharmacopoeia, the corresponding application materials for drug registration submitted shall comply with the relevant requirements of this version of the Chinese Pharmacopoeia.

Registration applications that have been accepted before the implementation of this version of the Chinese Pharmacopoeia and have not yet completed technical evaluation shall be subject to corresponding evaluation and approval by the drug regulatory authorities in accordance with the relevant requirements of this version of the Chinese Pharmacopoeia from the date of implementation. If the applicant needs to supplement technical information, it shall be submitted in one go.

Drugs approved for market according to the relevant requirements of the original pharmacopoeia standards after the promulgation of this version of the Chinese Pharmacopoeia and before its implementation shall comply with the relevant requirements of this version of the Chinese Pharmacopoeia within 6 months after approval.

9、 Drug marketing authorization holders, production enterprises, and drug registration applicants should actively prepare for the implementation of this version of the Chinese Pharmacopoeia, report any problems discovered during the implementation of the Chinese Pharmacopoeia to the National Pharmacopoeia Committee in a timely manner, and continuously study and improve drug quality standards to continuously enhance the level of drug quality control.

10、 Provincial drug regulatory departments should cooperate in promoting and implementing this version of the Chinese Pharmacopoeia, strengthen supervision and guidance during its implementation, and promptly collect and provide feedback on relevant issues and opinions.

11、 The National Pharmacopoeia Commission is responsible for organizing and coordinating the promotion, training, and technical guidance of this version of the Chinese Pharmacopoeia. It has set up a "Chinese Pharmacopoeia Implementation Column" on its official website to promptly respond to questions raised during implementation.

This is to announce.