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ICH guideline E2F on development safety update report

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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.

country worldwide. The start of the annual period for the DSUR is the month and date of the DIBD. When the sponsor’s first clinical trial is conducted in a country without a formal authorisation process, the sponsor should designate an appropriate date linked to the commencement of the first clinical trial.

  Worldwide

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