Summary
This is a machine-generated summary.
(1) The State Food and Drug Administration has issued a notice regarding the implementation of the 2025 edition of the Chinese Pharmacopoeia (hereinafter referred to as the Chinese Pharmacopoeia). The 2025 edition of the Chinese Pharmacopoeia was promulgated by the State Food and Drug Administration and the National Health Commission on February 29, 2025, and will take effect on October 1, 2025. The following are the details regarding the implementation of the new edition:
(2) 1. According to the Drug Management Law, all drugs must comply with national drug standards. The Chinese Pharmacopoeia is an essential component of national drug standards, which must be followed by all units involved in the development, production (importation), marketing, and use of drugs.
(3) 2. The Chinese Pharmacopoeia consists of prefaces, species texts, general technical requirements, and guiding principles. From the implementation date, all drug registration holders and manufacturers of marketed drugs must comply with this notice and the relevant requirements of the new edition of the Chinese Pharmacopoeia, with guiding principles being recommended technical requirements.
(4) 3. From the implementation date, all species that were previously included in previous editions of the Pharmacopoeia or local department standards, but are included in the new edition, will have the corresponding previous editions and local department standards abolished. If a species is not included in the new edition, the previous edition and local department standard will still be followed, but must meet the relevant general technical requirements of the new edition. Species that have been withdrawn from the market after evaluation will also have their corresponding previous editions and local department standards abolished.
(5) 4. After the new edition of the Pharmacopoeia is promulgated, drug registration holders must conduct relevant comparative research work to assess whether the drug registration standards comply with the new edition of the Pharmacopoeia. If a drug registration standard needs to be changed, the drug registration holder must submit a supplementary application, report, or record before the implementation date of the new edition, and implement the changes according to the relevant regulations.
(6) 5. If the drug registration standard includes more or different test items than those specified in the Pharmacopoeia, or if the quality indicators are stricter than those specified in the Pharmacopoeia, the registration standard should be implemented in conjunction with the corresponding items and indicators of the Pharmacopoeia. If the registration standard includes fewer test items than those specified in the Pharmacopoeia, or if the quality indicators are lower than those specified in the Pharmacopoeia, the Pharmacopoeia standards should be implemented.
(7) 6. If a change is made to the prescription, production process, raw materials, excipients, packaging materials, or containers that come into direct contact with the drug, the drug registration holder and manufacturer must conduct thorough research and verification according to the requirements of the Drug Registration Management Regulations, the Regulations on the Management of Changes to Registered Drugs (Trial), and other relevant technical guidance principles and pharmaceutical production quality management standards, and obtain approval, record, or report according to the relevant change categories.
(8) 7. Due to the special nature of solubility and release rate in quality control, if the registration standard of a generic drug approved for quality and efficacy consistency evaluation differs from the Chinese Pharmacopoeia, the registered standard should be followed.
(9) 8. For drugs with revised common names in the new edition of the Pharmacopoeia, the revised name should be used, and the original name can be used as a former name for a transitional period until the next edition of the Pharmacopoeia is implemented.
(10) 9. From the implementation date of the new edition of the Pharmacopoeia, all new drug registration applications must comply with the relevant requirements of the new edition. For registration applications that have been accepted but not completed before the implementation date, the drug regulatory departments should conduct the relevant evaluation and approval according to the new edition of the Pharmacopoeia. If additional technical data is required, it should be submitted at one time.
(11) 10. All provincial drug regulatory departments should provide guidance and supervision on the implementation of the new edition of the Pharmacopoeia, collect and feedback relevant problems and opinions, and provide training and technical guidance on the new edition.
(12) 11. The National Pharmacopoeia Committee is responsible for organizing and coordinating the training and technical guidance work of the new edition of the Pharmacopoeia, and setting up a "Chinese Pharmacopoeia Implementation Column" on its official website to answer questions and problems that arise during implementation.