Notice of the State Food and Drug Administration on the implementation of the Pharmacopoeia of the people's Republic of China (No. 80, 2020)
The 2020 edition of Pharmacopoeia of the people's Republic of China (hereinafter referred to as the "Chinese Pharmacopoeia") has been issued by the State Drug Administration and the state health and Health Commission Announcement No. 78 in 2020, which will be implemented from December 30, 2020. The relevant matters concerning the implementation of this edition of Chinese Pharmacopoeia are hereby announced as follows:
1．According to the drug administration law, drugs should meet the national drug standards. "Chinese Pharmacopoeia" is an important part of national drug standards. It is a legal technical standard that should be followed by relevant units such as drug development, production (import), marketing, use, supervision and management.
2. "Chinese Pharmacopoeia" is mainly composed of general specifications, text of varieties and general technical requirements. From the date of implementation, all drugs produced and marketed shall meet the relevant technical requirements of this edition of Chinese Pharmacopoeia.
3. As of the date of implementation, if the varieties originally included in the Chinese Pharmacopoeia and the standards issued by the Bureau (Ministry) are included in this edition of the Chinese Pharmacopoeia, the corresponding historical edition of the Chinese Pharmacopoeia and the standards issued by the Bureau (Ministry) shall be abolished at the same time; those not included in this edition of the Chinese Pharmacopoeia shall still comply with the relevant general technical requirements of this edition of the Chinese Pharmacopoeia For the varieties that have been cancelled or cancelled after the market evaluation, the corresponding historical Pharmacopoeia and the standards issued by the Bureau (Ministry) shall be abolished.
For the preparation specifications and preparation methods of traditional Chinese medicine not included in the main body of the Chinese pharmacopoeia in this edition, the quality standards shall be implemented according to the relevant requirements of the same varieties in this edition of Chinese Pharmacopoeia, and the specifications and preparation items shall be implemented according to the original approval documents.
4. If the inspection items contained in the drug registration standards are more than or different from those specified in the Pharmacopoeia, or the quality indicators are stricter than the requirements of the Pharmacopoeia, the corresponding items and indicators of the registration standards shall be implemented on the basis of the requirements of the Pharmacopoeia.
If the inspection items contained in the drug registration standards are less than those specified in the pharmacopoeia or the quality indicators are lower than the requirements of the Pharmacopoeia, the Pharmacopoeia shall be implemented. 5. Due to the particularity of dissolution, release and other items in quality control, if the generic drug registration standards approved according to the quality and efficacy consistency evaluation requirements of generic drugs are different from those in the Chinese Pharmacopoeia, the state drug regulatory department shall explain in the approval conclusion, and the applicant shall propose the revision state to the State Pharmacopoeia Committee within three months after the approval of the corresponding registration application Suggestions on the drug standard. Before the revision of Chinese pharmacopoeia is completed, it can be implemented according to the approved drug registration standards.
6. In order to meet the requirements of this edition of the Chinese Pharmacopoeia, in case of changes in drug prescription, production process, raw and auxiliary materials, etc., the drug marketing license holder and the manufacturer shall conduct full research and verification in accordance with the drug registration management measures, the technical guidelines for change research and the drug production quality management specifications, and approve and record according to the corresponding change categories After implementation or report.
7. If the general name of a drug has been revised in this edition of the Chinese Pharmacopoeia, the name specified in this edition of the Chinese Pharmacopoeia shall be used, and the original name may be used as a transitional name.
8. Since the implementation date of this edition of Chinese Pharmacopoeia, the corresponding application materials for drug registration shall meet the relevant requirements of this edition of Chinese Pharmacopoeia.
For registration applications accepted before the implementation date of this edition of Chinese Pharmacopoeia but not yet completed the technical review, the drug regulatory department shall carry out corresponding review and approval in accordance with the relevant requirements of this edition of Chinese Pharmacopoeia from the implementation date of this edition of Chinese Pharmacopoeia. If the applicant needs to supplement technical data, it shall be submitted at one time.
The relevant requirements of Chinese Pharmacopoeia should be met 6 months after the date of approval of this edition of Pharmacopoeia.
9. Drug marketing license holders, manufacturers and drug registration applicants should actively prepare for the implementation of this edition of the Chinese Pharmacopoeia, timely report the problems found in the implementation of the Chinese Pharmacopoeia to the State Pharmacopoeia Committee, and continuously study and improve the drug quality standards and continuously improve the drug quality control level.
10. All provincial drug supervision and administration departments should cooperate with the publicity and implementation of the 2020 edition of Chinese Pharmacopoeia, strengthen the supervision and guidance in the implementation of this edition of Pharmacopoeia, and timely collect and feedback relevant problems and opinions. 11. The State Pharmacopoeia Committee is responsible for the unified organization and coordination of the publicity, implementation, training and technical guidance of the 2020 edition of the Chinese Pharmacopoeia, and opening up an "executive column of the 2020 edition of the Chinese Pharmacopoeia" on the official website, and answering the problems reflected in the implementation in a timely manner.
It is hereby announced.
State Food and Drug Administration
July 3, 2020