Development safety update report (DSUR)

In Safety & pharmacovigilance

A DSUR is the annual safety report a sponsor prepares for a product still in development. It brings together the safety findings from the reporting period across all trials of that product and assesses whether the overall risk picture has changed. Its format is set by ICH E2F, so one report can serve multiple regions.

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Educational reference only. Where regional rules differ, follow the regulation and the written procedures that apply where you work.