In July this year, the State Food and Drug Administration issued a notice on the implementation of the Pharmacopoeia of the people's Republic of China 2020, which is now December 31, 2020, which means that the Pharmacopoeia of the people's Republic of China 2020 has come into effect.
According to the requirements of the announcement of the food and drug administration, there are 11 items that need to be paid attention to in the implementation of the Pharmacopoeia of the people's Republic of China in 2020, as follows:
1、 According to the drug administration law, drugs should meet the national drug standards. The Chinese pharmacopoeia is an important part of the national drug standards. It is a legal technical standard that should be followed by the relevant units of drug development, production (import), operation, use, supervision and management.
2、 Chinese pharmacopoeia is mainly composed of general rules, 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、 From the date of implementation, if the varieties originally included in the previous edition of the Pharmacopoeia and the standards issued by the Bureau (Ministry) are included in this edition of the Chinese Pharmacopoeia, the corresponding previous edition of the Pharmacopoeia and the standards issued by the Bureau (Ministry) will be abolished at the same time; if they are not included in this edition of the Chinese Pharmacopoeia, the corresponding previous edition of the Pharmacopoeia and the standards issued by the Bureau (Ministry) will still be implemented, but they shall meet the relevant general technical requirements of this edition of the Chinese Pharmacopoeia The corresponding Pharmacopoeia and the standards issued by the Bureau (Ministry) will be abolished for the varieties that are cancelled or cancelled in the post market evaluation.
For the preparation specifications and preparation methods of traditional Chinese medicine which are not included in the main text of this edition of Chinese Pharmacopoeia, the quality standards shall be implemented according to the relevant requirements of the same variety in this edition of Chinese Pharmacopoeia, and the specifications and preparation methods shall be implemented according to the original approval documents.
4、 If the test items contained in the drug registration standard are more than or different from those specified in the Pharmacopoeia, or the quality indicators are stricter than those specified in the Pharmacopoeia, the corresponding items and indicators of the registration standard shall be implemented on the basis of the requirements of the Pharmacopoeia.
If the test items contained in the drug registration standard are less than those specified in the Pharmacopoeia, or the quality index is lower than the requirements of the Pharmacopoeia, the provisions of 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 requirements of generic drug quality and efficacy consistency evaluation are different from those in the Chinese Pharmacopoeia, the state drug regulatory department shall explain them in the approval conclusion, and the applicant shall propose amendments to the State Pharmacopoeia Committee within three months after the approval of the corresponding registration application Suggestions on the national drug standards. Before the revision of the Chinese Pharmacopoeia, the approved drug registration standards can be followed.
6、 In order to meet the requirements of this edition of Chinese Pharmacopoeia, in case of changes in drug prescription, production process and source of raw and auxiliary materials, drug marketing license holders and manufacturers shall conduct full research and verification in accordance with the measures for the administration of drug registration, relevant technical guidelines for change research and drug production quality management specifications, and approve and record according to corresponding change categories Report after implementation.
7、 For drugs whose general name has been revised in this edition of Chinese Pharmacopoeia, the name specified in this edition of Chinese Pharmacopoeia should be used, and the original name can be used as a transitional name.
8、 From the date of implementation 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 that have been accepted before the implementation of this edition of Chinese Pharmacopoeia and have not yet completed the technical review, the drug regulatory department shall carry out the corresponding review and approval according to the relevant requirements of this edition of Chinese Pharmacopoeia from the implementation date of this edition of Chinese Pharmacopoeia, and the applicants who need to supplement the technical data shall complete the submission at one time.
Drugs approved for marketing according to the relevant requirements of the original Pharmacopoeia standards after the publication of this edition of Chinese Pharmacopoeia and before the implementation date shall meet the relevant requirements of this edition of Chinese Pharmacopoeia within 6 months after approval.
9、 Drug marketing license holders, manufacturers and drug registration applicants should actively make preparations for the implementation of this edition of the Chinese Pharmacopoeia, and timely report the problems found in the implementation of the Chinese Pharmacopoeia to the State Pharmacopoeia Committee. Meanwhile, they should continue to study and improve drug quality standards, and constantly improve the level of drug quality control.
10、 All provincial drug regulatory 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 Chinese 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, opening up the "executive column of the 2020 edition of the Chinese Pharmacopoeia" on the official website, and timely answering the problems reflected in the implementation.
January 04, 2021
