CCTV News: On March 25, the State Food and Drug Administration issued an announcement on the implementation of the 2025 edition of the "Pharmacopoeia of the People's Republic of China" (No. 32 of 2025).

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 State Food and Drug Administration and the National Health Commission's Announcement No. 29 of 2025 and will be implemented from October 1, 2025. The following announcement is now made on the implementation of this version of the Chinese Pharmacopoeia: 1. According to the provisions of the Drug Administration Law, drugs shall comply with national drug standards. The Chinese Pharmacopoeia is an important part of the national drug standards and is a statutory technical standard that relevant units such as drug development, production (import), operation, use and supervision and management should follow.

2. The Chinese Pharmacopoeia mainly includes general examples, 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 edition 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 the pharmacopoeia and local (department) standards issued by this edition of the "Chinese Pharmacopoeia" shall be abolished at the same time; if this edition of the "Chinese Pharmacopoeia" is not included in this edition, the corresponding pharmacopoeia and local (department) standards issued by this edition shall still be implemented, but shall comply with the relevant general technical requirements of this edition of the "Chinese Pharmacopoeia". The varieties that have been evaluated for revocation or cancellation after listing will be abolished. The corresponding version of the pharmacopoeia and the standards issued by the bureau (department) will be abolished.

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

4. After this version of the "Chinese Pharmacopoeia" is promulgated, if the drug registration standards are implemented, the drug marketing authorization holder shall promptly carry out relevant comparative research work to evaluate whether the drug registration standards meet the relevant requirements of the newly issued pharmacopoeia standards.

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

If there are more inspection items included in the drug registration standards than or different from those stipulated by the pharmacopoeia, or if the quality indicators are stricter than those required by the pharmacopoeia, the corresponding items and indicators of the registration standards shall be implemented at the same time on the basis of implementing the pharmacopoeia requirements. If the drug registration standard contains inspection items less than the pharmacopoeia regulations or the quality indicators are lower than the requirements of the pharmacopoeia, the pharmacopoeia regulations shall be implemented.

5. In order to comply with the requirements of this version of the Chinese Pharmacopoeia, if there are changes in drug prescriptions, production processes and raw materials, auxiliary materials, packaging materials and containers that directly contact drugs, the drug marketing authorization holder and manufacturer shall conduct full research and verification in accordance with the requirements of the "Drug Registration Management Measures", "Drug Change Management Measures for Post-Selling Drugs (Trial)", as well as relevant technical guidelines for change research and drug production quality management standards, and approve, register and implement or report according to the corresponding change category.

6. Due to the particularity of dissolution, release and other items in quality control, if the generic drug registration standards approved in accordance with the requirements of the quality and efficacy consistency evaluation of generic drug quality and efficacy, they shall be implemented according to the approved drug registration standards.

7. Drugs whose common name has been revised in this version of the Chinese Pharmacopoeia should use the names stated in this version of the Chinese Pharmacopoeia, and their original name can be used as a former name. Before the implementation of the next version of the Pharmacopoeia, the name used can be used simultaneously with the name stated in this version of the Chinese Pharmacopoeia.

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

A registration application that has been accepted before the implementation of this version of the Chinese Pharmacopoeia and has not yet completed the technical review, the drug supervision and administration department shall carry out corresponding review and approval in accordance with the relevant requirements of this version of the Chinese Pharmacopoeia. If the applicant needs to supplement technical information, it shall complete the submission at one time.

Drugs approved for marketing in accordance with the relevant requirements of the original pharmacopoeia standards after the promulgation and before the implementation date of this version of the "Chinese Pharmacopoeia", they must meet the relevant requirements of this version of the "Chinese Pharmacopoeia" within 6 months after approval.

9. Drug marketing authorization holders, manufacturers and drug registration applicants should actively prepare for the implementation of this version of the Chinese Pharmacopoeia, and report problems found during the implementation of the Chinese Pharmacopoeia to the National Pharmacopoeia Commission in a timely manner. At the same time, we should continue to study and improve drug quality standards and continuously improve drug quality control levels.

10. All provincial drug supervision and administration departments shall cooperate to promote and implement this version of the "Chinese Pharmacopoeia", strengthen supervision and guidance in the implementation of this version of the pharmacopoeia, and promptly collect and feedback related issues and opinions.

11. The National Pharmacopoeia Commission is responsible for organizing and coordinating the publicity and implementation training and technical guidance of this version of the Chinese Pharmacopoeia. It has opened the "Chinese Pharmacopoeia Implementation Column" on the official website to promptly respond to the issues reflected in the implementation.