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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.

New safety data related to combination therapies ..... 17. 3.9. Safety findings from non ... reports. 1. This guideline defines the recommended content and format of a DSUR and provides an ... (PSUR) to fulfil national and regional requirements for periodic reporting on the safety of approved . 5. For the purposes of this document, we use the ...

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