Answer： The main purpose of DSUR is for drug registration applicants (hereinafter referred to as applicants, including applicants) to conduct a comprehensive and in-depth annual review and evaluation of safety information related to drugs (whether on the market or not) collected during the reporting period. According to the common general technical issues regarding information disclosure on the CDE website, China has specific regulations on the scope of DSUR submission: clinical trial applications, supplementary applications, reexamination applications, drug marketing license applications, re registration applications, and other approved clinical trials (i.e. conducted in accordance with the "approval documents"), The Phase IV trial conducted in accordance with the marketing approval documents (including the applicant's belief that it is necessary to register on the "Drug Clinical Trial Registration and Information Disclosure Platform", and the applicant's plan to use the trial results as feedback on approval issues or as part of subsequent submissions), the above are several typical cases where DSUR needs to be submitted. In principle, BE experiments conducted in the form of registration for the consistency evaluation of chemical generic drugs do not need to be submitted. 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. Article 48 of the Quality Management Standards for Clinical Trials of Drugs: Applicants shall report adverse drug reactions in accordance with the requirements and time limits. （1） After receiving safety related information from any source, the applicant should immediately analyze and evaluate it, including severity, correlation with the investigational drug, and whether it is an expected event. The applicant shall promptly report suspicious and unexpected serious adverse reactions to all researchers participating in clinical trials, clinical trial institutions, and ethics committees; Applicants should report suspicious and unexpected serious adverse reactions to the drug regulatory department and the health regulatory department. （2） The safety update report provided by the sponsor during drug development should include an assessment of the risks and benefits of clinical trials, and relevant information should be communicated to all researchers participating in clinical trials, clinical trial institutions, and ethics committees. In summary, tests conducted through approval documents require submission of DSUR; For BE trials conducted through filing, in principle, there is no need to submit a DSUR. If serious unexpected adverse reactions occur during the trial, a DSUR can be considered to be submitted to the drug approval center. Reference: 1) Notice of the Drug Review Center of the State Food and Drug Administration on the Release of the "Management Standards for Safety Update Reports during Research and Development (Trial)" (No. 7 of 2020) 2) Drug Review Center of the State Food and Drug Administration - Information Disclosure - Common General Technical Issues 3) Announcement of the National Health Commission of the State Food and Drug Administration on the Release of the Quality Management Standards for Clinical Trials of Drugs (No. 57 of 2020)