• Clinical Safety E1 - E2F

    Code Document Title Previously coded
    • E2FDevelopment Safety Update Report

      Finalised Guideline:
      August 2010

      E2F
      Concept Paper
      Business Plan
      DSUR Examples Commercial Sponsors
      DSUR Examples non-Commercial Sponsors
      Presentation on E2F
      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

      EU:

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

      MHLW:

      To be notified

      FDA:

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