• Q6A- Q6B Specifications

    Code Document Title Previously coded
    • Finalised Guideline:
      October 1999

      Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in October 1999. This addresses the process of selecting tests and methods and setting specifications for the testing of drug substances and dosage forms. Account has been taken of the considerable guidance and background information which are present in existing regional documents.

      Implementation :

      Step 5

      :

      EC, EuropeAdopted by CPMP, November 1999, issued as CPMP/ICH/367/96

      :

      MHLW/PMDA, Japan Adopted May 2001, PMSB/ELD Notification No. 568

      :

      FDA, US Published in the Federal Register, 29 December 2000, Vol. 65, No. 251, p. 83041-63

      :

      Health Canada, Canada Implemented 29 January 2016 File #: 16-100136-12

      :

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