Answer： In the answer to the "Common General Technical Questions" released by CDE, On January 26, 2021, the following response was given to the scope of submission for DSUR: "Typical situations - clinical trials that require submission of clinical trial applications, supplementary applications, review applications, drug marketing license applications, re registration applications, and other approvals/notifications that clearly permit the conduct of clinical trials (i.e., conducted in accordance with the" approval "). Phase IV trials that are carried out in accordance with the marketing license approval documents (including those that the applicant believes need to be registered on the" Drug Clinical Trial Registration and Information Disclosure Platform ") Typical cases where registration is required and the applicant plans to use the test results as feedback on approval issues or as part of subsequent submissions - in principle, it is not necessary to submit them for chemical generic drug consistency evaluation. For BE trials conducted in the form of filing, it is not necessary to submit them in principle. The BE trial of chemical generic drugs conducted solely through registration is not within the scope of mandatory submission in principle. However, if the requirements of Article 48 of the Good Clinical Practice for Drug Trials are met, the applicant may consider submitting a DSUR to the Drug Review Center.