• E2A - E2F Pharmacovigilance

    Code Document Title Previously coded
    • Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in August 2010.
      The main focus of the DSUR is data from interventional clinical trials (referred to in this document as "clinical trials") of investigational drugs including biologicals, with or without a marketing approval, whether conducted by commercial or non-commercial sponsors.

      Following the completion of the E2F Step 4 Guideline, the E2F EWG developed DSUR Examples for commercial and non-commercial sponsors to help with the use of the E2F Guideline. It should be noted that these documents are only examples and therefore did not go through the formal ICH Step Process.

      Implementation :

      Step 5

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      EC, EuropeAdopted by CHMP, September 2010, issued as EMA/CHMP/ICH/309348/2008

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      MHLW/PMDA, Japan -  Adopted 28 December 2012, PFSB/SD Notification 1228-1

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      FDA, US Published in the Federal Register, 23 August 2011, Vol. 76, No. 163, p. 52667-8

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      Health Canada, Canada Implemented 20 December 2012, File #: 12-122199-139

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      Swissmedic, Switzerland - Refer to the press release on Swissmedic, Switzerland's website