Transcription of ICH guideline E2F on development safety update report
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ICH guideline E2F on development safety update report
September 2011 EMA/CHMP/ICH/309348/2008 ICH guideline E2F on development safety update report Step 5 Transmission to CHMP June 2008 Adoption by CHMP for release for consultation June 2008 End of consultation (deadline for comments) December 2008 Final adoption by CHMP September 2010 Date for coming into effect September 2011 7 Westferry Circus Canary Wharf London E14 4HB United Kingdom An agency of the European Union Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416 E-mail Website European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged. E2F development of safety update report Table of contents 1. Introduction .. 4 Background .. 4 Objectives .. 4 Scope of the DSUR .. 5 Relation of the DSUR to the periodic safety update report .. 5 Recipients of the DSUR .. 6 2. General principles .. 6 Single DSUR for an active substance .. 6 Periodicity and DSUR data lock point* .. 6 Duration of DSUR submissions.
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 …
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