Be careful! Announcement of the State Food and Drug Administration on matters related to the implementation of drug standards in the conformity evaluation of quality and efficacy of generic drugs

In order to promote the consistency evaluation of quality and efficacy of generic drugs and clarify the relationship between generic drug registration standards and national drug standards such as Pharmacopoeia of the people's Republic of China (hereinafter referred to as "Chinese Pharmacopoeia"), we hereby announce the following matters: 1、 In accordance with the relevant provisions of the announcement of the former State Food and Drug Administration on the implementation of the 2015 edition of the Pharmacopoeia of the people's Republic of China (No 105 in 2015), the Chinese pharmacopoeia is the legal technical standard to be followed by the relevant units of drug development, production (import), operation, use, supervision and management, and the inspection items are included in the drug registration standard If the contents are more than (including different from) the provisions of the pharmacopoeia or the quality indexes are stricter than the requirements of the Pharmacopoeia, the corresponding items and indexes of the original registration standard shall be implemented on the basis of the requirements of the Pharmacopoeia 2、 The drug registration standards approved by the drug evaluation center of the State Drug Administration Based on the registration application submitted by the applicant shall comply with the relevant technical requirements of the Chinese Pharmacopoeia 3、 Due to the particularity of dissolution, release and other items in quality control, if the generic registration standard approved according to the quality and efficacy consistency evaluation requirements of generic drugs is different from the national drug standards such as China Pharmacopoeia, the drug evaluation center of the State Drug Administration shall explain it in the evaluation conclusion, and the applicant shall submit it to the national pharmacopoeia committee within three months after the product is approved The national drug standards will be revised After receiving the proposal to revise the national drug standard, the national pharmacopoeia committee shall carry out technical evaluation according to relevant working procedures and decide whether to initiate the corresponding revision of the national drug standard Before the revision of the national drug standards such as the Chinese Pharmacopoeia, the production enterprises may implement the approved drug registration standards It is hereby announced SFDA July 30, 2019