ICH E2F Development safety update report - Scientific guideline
Table of contents
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
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ICH guideline E2F on development safety update report - Step 5 (PDF/352.87 KB)
Adopted
First published: 30/09/2010
Last updated: 30/09/2010
Legal effective date: 01/09/2011
EMA/CHMP/ICH/309348/2008 -
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ICH: E 2 F: Development safety update report - Step 3 (PDF/216.41 KB)
Adopted
First published: 01/06/2008
Last updated: 18/10/2010
Legal effective date: 01/09/2011
EMA/CHMP/ICH/309348/2008