(No.80 of 2020)
The 2020 edition of People's Republic of China (PRC) Pharmacopoeia (hereinafter referred to as China Pharmacopoeia) has been issued by Announcement No.78 of the National Health and Wellness Committee of the State Pharmaceutical Products Administration in 2020, and will be implemented as of February 30, 2020. The relevant matters concerning the implementation of this edition of China Pharmacopoeia are hereby announced as follows:
1. According to the provisions of the Drug Administration Law, drugs should meet the national drug standards. China Pharmacopoeia is an important part of national drug standards, and it is a legal technical standard that relevant units such as drug development, production (import), management, use, supervision and management should follow.
Two, "China Pharmacopoeia" is mainly composed of examples, 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 China Pharmacopoeia.
Three, since the date of implementation, where the original collection in the calendar version of the Pharmacopoeia, bureau (department) promulgated standards of varieties, this edition of the China Pharmacopoeia collection of the corresponding calendar version of the Pharmacopoeia, bureau (department) promulgated standards shall be abolished at the same time; If this edition of China Pharmacopoeia is not included, the corresponding calendar edition of Pharmacopoeia and the standards issued by the bureau (department) shall still be implemented, but it shall meet the relevant general technical requirements of this edition of China Pharmacopoeia. Varieties that have been cancelled or cancelled after listing shall be abolished according to the corresponding calendar edition of Pharmacopoeia and the standards issued by the bureau (department).
The quality standards of specifications and preparation methods of traditional Chinese medicine preparations not included in the text of this edition of China Pharmacopoeia shall be implemented according to the relevant requirements of the same variety in this edition of China Pharmacopoeia, and the specifications and preparation methods shall be implemented according to the original approval number respectively.
Four, the acceptance test items in the drug registration standards are more than or different from the provisions of the Pharmacopoeia, or the quality indicators are stricter than the requirements of the Pharmacopoeia. On the basis of the implementation of the requirements of the Pharmacopoeia, the registration standards of the corresponding items and indicators should be implemented at the same time.
If the drug registration standard contains less inspection items than the Pharmacopoeia or the quality index is lower than the requirements of the Pharmacopoeia, the provisions of the Pharmacopoeia shall apply.
Five, due to the particularity of dissolution, release and other items in quality control, in accordance with the requirements of the consistency evaluation of generic drug quality and efficacy, the registration standard of generic drugs is different from that of China Pharmacopoeia, and the state drug supervision and administration department shall explain it in the conclusion of examination and approval, and the applicant shall put forward suggestions for revising the national drug standard to the State Pharmacopoeia Committee within three months after the corresponding registration application is approved. Before the revision of China Pharmacopoeia, it can be implemented according to the approved drug registration standards.
Six, in order to meet the requirements of this edition of China Pharmacopoeia, such as involving changes in drug prescriptions, production processes and raw material sources, drug marketing license holders and production enterprises should fully study and verify in accordance with the requirements of the Measures for the Administration of Drug Registration, Change Research and Good Manufacturing Practices and other related technical guidelines, and implement or report the changes according to the corresponding categories after approval.
Seven, this edition of "China Pharmacopoeia" has been revised generic names of drugs, should use the name specified in this edition of "China Pharmacopoeia", and its original name can be used as a transitional name.
Eight, this edition of "China Pharmacopoeia" from the date of implementation, to apply for drug registration, the corresponding application materials should meet the relevant requirements of this edition of "China Pharmacopoeia".
The application for registration that has been accepted before the implementation date of this edition of China Pharmacopoeia and has not yet completed the technical review shall be reviewed and approved by the pharmaceutical supervisory and administrative department according to the relevant requirements of this edition of China Pharmacopoeia from the implementation date of this edition of China Pharmacopoeia, and the applicant who needs to supplement the technical information shall complete the submission at one time.
After the release of this edition of China Pharmacopoeia and before the implementation date, the drugs approved for marketing according to the relevant requirements of the original Pharmacopoeia standards shall meet the relevant requirements of this edition of China Pharmacopoeia within 6 months after approval.
Nine, drug marketing license holders, production enterprises and drug registration applicants should actively make preparations for the implementation of this edition of China Pharmacopoeia, and report the problems found in the implementation of China Pharmacopoeia to the State Pharmacopoeia Committee in a timely manner. At the same time, we should continue to study and improve drug quality standards, and constantly improve the level of drug quality control.
Ten, the provincial drug supervision and management departments should cooperate with the publicity and implementation of the 2020 edition of China Pharmacopoeia, strengthen supervision and guidance on the implementation of this edition of Pharmacopoeia, timely collect and feedback related questions and opinions.
Eleven, the National Pharmacopoeia Committee is responsible for the unified organization and coordination of the 2020 edition of the China Pharmacopoeia publicity and training and technical guidance, in official website to open up the "2020 edition of the China Pharmacopoeia executive column", timely answer the questions reflected in the implementation.
It is hereby announced.