ICH E2F Development safety update report

Current effective version

PDF icon<b>Adopted guideline</b>

Reference numberCHMP/ICH/309348/08
Published01/09/2011
Effective from01/09/2011
KeywordsDevelopment 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
DescriptionThis 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.


Document history

First version

Current version

PDF iconAdopted guideline


PDF iconDraft guideline

In operation: 01/11/2010–present


Published: 01/06/2008

How useful was this page?

Add your rating
Average
1 rating