NMPA Issues Rules for Development Safety Update Reports(DSUR)

On 01 July 2020, China’s NMPA’s Center for  Drug Evaluation(CDE)  has issued administrative rules titled “Management Guidance/Standard for Development Safety Update Report” (No. 7 of 2020).

The rules were established to regulate the creation and management of development safety update reports (DSUR) in line with the requirements established in the new regulations for Drug Registration.

The requirements contained in the Drug Registration Regulation necessitates the applicants for drug registration to submit development safety update reports (DSUR) in a periodic manner to CDE. The scope of the rules covers General Provisions; Basic Principles; Preparation Requirements of DSUR; Submission and Other Requirements.

The annexure of the document contains forms, templates as well as relevant checklists.

The following are the key important changes:-

a) When preparing a DSUR, the applicant should provide the following information under “Region-Specific Information” or in the form of a regional Appendix to the DSUR:
1.Cumulative summary tabulation of serious adverse reactions (SARs);
2.List of subjects who died in China during the reporting period;
3.List of subjects in China who dropped out of the clinical trial due to any adverse event within the reporting period;
4.Summary tabulations of changes to the clinical trial protocol or new clinical findings, non-clinical or pharmaceutical changes or new findings occurring during the reporting period;
5.Overview of the overall investigational plan for the next reporting period.

b) Article 6: The initial submission should be submitted within two months after the first DIBD in China following the China clinical trial is approved, and the subsequent submission period should also be based on DIBD.
C) Article 11: The DSUR is reported in Chinese, the “Line Listing of Serious Adverse Reactions during the Reporting Period” can be reported in either Chinese or English.

More information could be gathered from the following link

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