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 shall come into effect on October 1, 2025. The following is an announcement concerning the implementation of this edition of the Chinese Pharmacopoeia:

　　I. In accordance with the provisions of the Pharmaceutical Administration Law, drugs shall comply with national drug standards. The Chinese Pharmacopoeia is an important component of national drug standards, and is a legally mandated technical standard that should be followed by all relevant entities involved in the research, production (import), operation, use, and supervision and management of drugs.

　　II. The Chinese Pharmacopoeia mainly includes a preface, monographs, general technical requirements, and guidelines. From the date of implementation, all drug marketing authorization holders and drugs that are on the market should comply with the requirements of this announcement and this edition of the Chinese Pharmacopoeia. Among them, the requirements of the guidelines are recommended technical requirements.

　　III. From the date of implementation, for items originally included in previous editions of the pharmacopoeia and standards issued by the authorities (ministries), if included in this edition of the Chinese Pharmacopoeia, the corresponding previous editions of the pharmacopoeia and the standards issued by the authorities (ministries) shall be abolished simultaneously; if not included in this edition of the Chinese Pharmacopoeia, the corresponding previous editions of the pharmacopoeia and the standards issued by the authorities (ministries) shall still be implemented, but they shall comply with the relevant general technical requirements of this edition of the Chinese Pharmacopoeia. For items that have been revoked or cancelled after market evaluation, the corresponding previous editions of the pharmacopoeia and standards issued by the authorities (ministries) shall be abolished.

　　For preparations and specifications, and traditional Chinese medicine preparation methods not included in the monograph of this edition of the Chinese Pharmacopoeia, their quality standards shall be implemented in accordance with the relevant requirements of the same variety in this edition of the Chinese Pharmacopoeia, while the specification items and preparation method items shall be implemented in accordance with the original approved documents.

　　IV. After the promulgation of this edition of the Chinese Pharmacopoeia, for those implementing drug registration standards, drug marketing authorization holders should promptly carry out relevant comparative research to assess whether the drug registration standards comply with the requirements of the newly promulgated pharmacopoeia standards.

　　For those requiring changes to drug registration standards, drug marketing authorization holders shall, before the implementation of this edition of the Chinese Pharmacopoeia, submit supplementary applications, filings, or reports in accordance with the relevant regulations on the post-market management of drugs, and implement them as required.

　　If a drug registration standard includes more or different testing items than those prescribed in the pharmacopoeia, or if the quality indicators are stricter than the pharmacopoeia requirements, the corresponding items and indicators of the registration standard should be implemented in addition to the pharmacopoeia requirements. If a drug registration standard includes fewer testing items than those prescribed in the pharmacopoeia, or if the quality indicators are lower than the pharmacopoeia requirements, the pharmacopoeia regulations shall be implemented.

　　V. To comply with the requirements of this edition of the Chinese Pharmacopoeia, if changes are involved in drug prescriptions, production processes, and raw materials, excipients, and packaging materials and containers that are in direct contact with drugs, drug marketing authorization holders and manufacturers should conduct sufficient research and verification in accordance with the "Regulations on Drug Registration Management," "Provisional Measures for Post-Market Change Management of Drugs," and relevant technical guidelines for change research and Good Manufacturing Practices for Drugs, and implement or report them after approval or filing according to the corresponding change categories.

　　VI. Due to the particularity of dissolution and release items in quality control, for generic drug registration standards approved in accordance with the requirements of the consistency evaluation of quality and efficacy of generic drugs that differ from the Chinese Pharmacopoeia, the approved drug registration standards shall be implemented.

　　VII. For drugs whose common names have been revised in this edition of the Chinese Pharmacopoeia, the names listed in this edition of the Chinese Pharmacopoeia shall be used, and the original names can be used as former names for the transition. Before the implementation of the next edition of the pharmacopoeia, the former names may be used simultaneously with the names listed in this edition of the Chinese Pharmacopoeia.

　　VIII. From the date of implementation of this edition of the Chinese Pharmacopoeia, drug registration applications submitted shall comply with the relevant requirements of this edition of the Chinese Pharmacopoeia.

　　For registration applications that have been accepted before the implementation of this edition of the Chinese Pharmacopoeia and have not yet completed technical review, the drug supervision and management department shall conduct the relevant review and approval in accordance with the requirements of this edition of the Chinese Pharmacopoeia from the date of implementation of this edition of the Chinese Pharmacopoeia. If the applicant needs to supplement technical data, it should be submitted in one go.

　　Drugs approved for marketing before the implementation date but after the promulgation date of this edition of the Chinese Pharmacopoeia according to the relevant requirements of the original pharmacopoeia standards should comply with the relevant requirements of this edition of the Chinese Pharmacopoeia within 6 months of approval.

　　IX. Drug marketing authorization holders, manufacturers, and drug registration applicants should actively prepare for the implementation of this edition of the Chinese Pharmacopoeia, promptly report any problems found during the implementation of the Chinese Pharmacopoeia to the National Pharmacopoeia Committee, and continuously improve drug quality standards and continuously improve drug quality control levels.

　　X. Provincial drug supervision and management departments should cooperate to promote and implement this edition of the Chinese Pharmacopoeia, strengthen supervision and guidance on the implementation of this edition of the pharmacopoeia, and promptly collect and feed back relevant problems and opinions.

　　XI. The National Pharmacopoeia Committee is responsible for organizing and coordinating the publicity, training, and technical guidance of this edition of the Chinese Pharmacopoeia, and will set up a "Chinese Pharmacopoeia Implementation Column" on its official website to promptly answer questions reflected during implementation.

　　This is hereby announced.

National Medical Products Administration

March 25, 2025