ICH E2F Development safety update report - Scientific guideline

This document proposes a common standard for periodic reporting on drugs under development among the ICH regions - the development safety update report (DSUR). It defines the recommended content and format of a DSUR and provides an outline of points to be considered in its preparation and submission.

Keywords: Development safety update report (DSUR), active substance, periodicity, data lock point, combination therapies, reference safety information, clinical trials, cumulative subject exposure, line listings, new safety data, non-clinical data, literature, lack of efficacy, late-breaking information, benefit-risk

Current effective version

ICH guideline E2F on development safety update report - Step 5

Adopted Reference Number: EMA/CHMP/ICH/309348/2008 Legal effective date: 01/09/2011 Summary:

The DSUR proposed in this guideline is intended to be a common standard for periodic reporting on drugs under development 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. 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.

ICH: E 2 F: Development safety update report - Step 3

Adopted Reference Number: EMA/CHMP/ICH/309348/2008 Legal effective date: 01/09/2011