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 announcement concerns the implementation of this edition of the Chinese Pharmacopoeia:

　　I. In accordance with the provisions of the Pharmaceutical Administration Law, drugs must conform to 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 units involved in drug research, production (import), operation, use, and supervision and management.

　　II. The Chinese Pharmacopoeia mainly includes general notes, monographs, general chapters, and guidelines. From the date of implementation, all drug marketing authorization holders and drugs that have been marketed should comply with the requirements of this announcement and this edition of the Chinese Pharmacopoeia. The requirements related to guidelines are recommended technical requirements.

　　III. From the date of implementation, for any drug previously included in previous editions of the pharmacopoeia or standards issued by the Ministry (Bureau), if included in this edition of the Chinese Pharmacopoeia, the corresponding previous editions of the pharmacopoeia and Ministry (Bureau) issued standards shall be abolished simultaneously; if not included in this edition of the Chinese Pharmacopoeia, the corresponding previous editions of the pharmacopoeia and Ministry (Bureau) issued standards shall still be implemented, but must comply with the relevant general chapters of this edition of the Chinese Pharmacopoeia. For drugs that have been withdrawn or cancelled after marketing authorization, the corresponding previous editions of the pharmacopoeia and Ministry (Bureau) issued standards shall be abolished.

　　For dosage forms and preparation methods of traditional Chinese medicine 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 this edition of the Chinese Pharmacopoeia for the same drug; the specifications and preparation methods 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 conduct relevant comparative studies to assess whether the drug registration standards meet the requirements of the newly promulgated pharmacopoeia standards.

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

　　If the drug registration standards include more or different testing items than those specified in the pharmacopoeia, or if the quality indicators are stricter than the pharmacopoeia requirements, the corresponding items and indicators of the registration standards should be implemented in addition to the pharmacopoeia requirements. If the drug registration standards include fewer testing items than those specified in the pharmacopoeia or if the quality indicators are lower than the pharmacopoeia requirements, the pharmacopoeia requirements should be implemented.

　　V. To meet the requirements of this edition of the Chinese Pharmacopoeia, if changes are involved in drug prescriptions, production processes, and raw materials, excipients, packaging materials and containers in direct contact with drugs, etc., drug marketing authorization holders and manufacturers should conduct sufficient research and verification in accordance with the "Regulations on Drug Registration Management", "Provisional Measures for the Management of Post-Marketing Changes of Drugs", 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 category.

　　VI. Due to the particularity of dissolution and release tests in quality control, for generic drugs whose registration standards approved according to the consistency evaluation requirements of quality and efficacy of generic drugs are different from those of 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 should be used, and the original names can be used as former names for a transitional period. Before the implementation of the next edition of the pharmacopoeia, the former names can 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 should 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, from the date of implementation of this edition of the Chinese Pharmacopoeia, the drug regulatory authorities should conduct the corresponding review and approval in accordance with the relevant requirements of this edition of the Chinese Pharmacopoeia. If the applicant needs to supplement technical data, it should be submitted at once.

　　Drugs approved for marketing before the implementation date of this edition of the Chinese Pharmacopoeia but after its promulgation date, in accordance with the relevant requirements of the original pharmacopoeia standards, should meet the relevant requirements of this edition of the Chinese Pharmacopoeia within 6 months after 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 encountered during the implementation of the Chinese Pharmacopoeia to the National Pharmacopoeia Commission, and should continuously research and improve drug quality standards and continuously improve drug quality control levels.

　　X. Provincial drug regulatory authorities should cooperate in the publicity and implementation of this edition of the Chinese Pharmacopoeia, strengthen supervision and guidance during the implementation of this edition of the pharmacopoeia, and promptly collect and feedback relevant problems and opinions.

　　XI. The National Pharmacopoeia Commission 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 raised during implementation.

　　This is hereby announced.

National Medical Products Administration

March 25, 2025