In order to promote the quality and efficacy consistency evaluation of generic drugs, and clarify the relationship between generic drug registration standards and national drug standards such as the Pharmacopoeia of the People's Republic of China (hereinafter referred to as the Chinese Pharmacopoeia), the relevant matters are hereby announced as follows:
1. In accordance with the relevant provisions of the former State Food and Drug Administration's Announcement on the Implementation of the 2015 Edition of the Pharmacopoeia of the People's Republic of China (No. 105 of 2015), the Chinese Pharmacopoeia is a drug development, production (import), The statutory technical standards that should be followed by relevant units such as operation, use, supervision and management; if the inspection items contained in the drug registration standards are more than (including different from) the provisions of the pharmacopoeia or the quality indicators are stricter than the requirements of the pharmacopoeia, the corresponding items and indicators of the original registration standards shall be implemented on the basis of the requirements of the pharmacopoeia.
The drug registration standards approved by the Drug Evaluation Center of the State Drug Administration of 2. based on the registration application submitted by the applicant shall implement the relevant technical requirements of the Chinese Pharmacopoeia.
3. due to the particularity of dissolution, release and other items in quality control, the registration standards of generic drugs approved according to the requirements of quality and efficacy consistency evaluation of generic drugs are different from the national drug standards such as the Chinese Pharmacopoeia, the Drug Evaluation Center of the State Drug Administration shall explain it in the evaluation conclusion, and the applicant shall put forward suggestions for revising the national drug standards to the State Pharmacopoeia Commission within three months after the product is approved. After receiving the proposal to revise the national drug standards, the State Pharmacopoeia Committee shall conduct technical evaluation in accordance with the relevant working procedures and decide whether to set up a project to carry out the corresponding revision of the national drug standards. Before the revision of the national drug standards such as the Chinese Pharmacopoeia is completed, the manufacturer may implement the approved drug registration standards.
It is hereby announced.

State Food and Drug Administration
30 July 2019