• E5 Ethnic Factors

    Code Document Title Previously coded
    • Finalised Guideline:
      February 1998

      Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in February 1998. This document addresses the intrinsic characteristics of the drug recipient and extrinsic characteristics associated with environment and culture that could affect the results of clinical studies carried out in regions and describes the concept of the "bridging study" that a new region may request to determine whether data from another region are applicable to its population.

      Implementation :

      Step 5

      :

      EC, EuropeAdopted by CPMP, March 1998, issued as CPMP/ICH/289/95

      :

      MHLW/PMDA, Japan Adopted August 1998, PMSB/ELD Notification No. 672, PMSB Notification No. 739

      :

      FDA, US Published in the Federal Register, 10 June 1998, Vol. 63, No. 111, p. 31790

      :

      Health Canada, Canada Implemented 18 December 2015, File #: 15-113552-719.

      :

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