• S6 Biotechnological Products

    Code Document Title Previously coded
    • Finalised Guideline:
      June 2011

      Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in July 1997. This document covers the pre-clinical safety testing requirements for biotechnological products. It addresses the use of animal models of disease, determination of when genotoxicity assays and carcinogenicity studies should be performed, and the impact of antibody formation on duration of toxicology studies.

      An addendum was proposed to provide clarification on S6 and an update of the following topics discussed in the original ICH S6 Guideline: species selection, study design, immunogenicity, reproductive and developmental toxicity and assessment of carcinogenic potential. Scientific advances and experience gained since publication of the original ICH S6 Guideline call for this addendum. The harmonised addendum provides further complementary guidance to the S6 Guideline and helps to define the current recommendations and reduce the likelihood that substantial differences will exist among regions.

      The addendum reached Step 4 of the harmonisation process in June 2011 and was integrated as part II in the core Guideline that was then renamed S6(R1).

      Implementation :

      Step 5

      :

      EC, EuropeAdopted by CPMP, September 1997, issued as CPMP/ICH/302/95

      :

      MHLW/PMDA, Japan Adopted February 2000, PAB/PCD Notification No. 326

      :

      FDA, United States Published in the Federal Register, 18 November 1997 , Vol. 62, No. 222, p. 61515

      :

      Health Canada, Canada Implemented 10 February 2003, Catalogue No. H49/-173/2003E

      :

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

      Addendum: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

      Implementation :

      Step 5

      :

      EC, EuropeAdopted by CHMP, July 2011, issued as EMA/CHMP/ICH/731268/1998

      :

      MHLW/PMDA, Japan Adopted March 2012, PFSB/ELD Notification No. 0323-1

      :

      FDA, United States Published in the Federal Register, 18 May 2012, Vol. 77, No. 97, p. 29665-6

      :

      Health Canada, Canada Implemented 22 January 2016, File #: 15-114041-80

      :

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