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EMA: Scientific guideline: ICH guideline E2F: Note for guidance on development safety update reports: Step 4

19.10.2010
The Development Safety Update Report (DSUR) proposed in this guideline is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study) among the ICH regions. US and EU regulators consider that the DSUR, submitted annually, would meet national and regional requirements currently met by the US IND Annual Report and the EU Annual Safety Report, respectively, and can therefore take the place of these existing reports.1 This guideline defines the recommended content and format of a DSUR and provides an outline of points to be considered in its preparation and submission.