• E8 General Considerations for Clinical Trials

    Code Document Title Previously coded
    • Finalised Guideline:
      July 1997

      Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in July 1997. This document sets out the general scientific principles for the conduct, performance and control of clinical trials. The Guideline addresses a wide range of subjects in the design and execution of clinical trials.

      Implementation :

      Step 5

      :

      EC, EuropeAdopted by CPMP, September 1997, issued as CPMP/ICH/291/95

      :

      MHLW/PMDA, Japan Adopted April 1998, PMSB/ELD Notification No. 380

      :

      FDA, US Published in the Federal Register, 17 December 1997, Vol. 62, No. 242, p. 66113

      :

      Health Canada, Canada Implemented 1 May 1998, Catalogue No. H42-2/67-12-1997IN

      :

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