• E3 Clinical Study Reports

    Code Document Title Previously coded
    • Finalised Q&As:
      July 2012

      Description :

      Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the E3 Guideline have resulted in the need for some clarification. This supplementary Questions and Answers document intends to clarify key issues.

      In July 2012, minor typographical errors were corrected in the Answer to Question 6 and the document was renamed R1.

      Implementation :

      Step 5

      EC :

      Transmission to CHMP and release for information, July 2012, issued as EMA/CHMP/ICH/435606/2012

      MHLW/PMDA :

      Adopted 18 October 2012, PFSB/ELD Administrative Notice

      FDA :

      Posted on FDA website on 25 January 2013

      Health Canada :

      Implemented 18 December 2015, File #: 15-113539-305

      Swissmedic :

      Please refer to the press release on Swissmedic’s website for information on implementation