• S2 Genotoxicity Studies

    Code Document Title Previously coded
    • Finalised Guideline:
      November 2011

      Description :

      The tripartite harmonised ICH Guideline was finalised under Step 4 in November 2011. It replaces and combines the ICH S2A and S2B Guidelines:

      S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals; The tripartite harmonised ICH Guideline was finalised under Step 4 in July 1995. This document provided specific guidance and recommendations for in vitro and in vivo tests and on the evaluation of test results. It includes a glossary of terms related to genotoxicity tests to improve consistency in applications.

      S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals; The tripartite harmonised ICH Guideline was finalised under Step 4 in July 1997. This document addressed two fundamental areas of genotoxicity testing: the identification of a standard set of assays to be conducted for registration, and the extent of confirmatory experimentation in any particular genotoxicity assay in the standard battery.

      The purpose of the revision of this combined Guideline is to optimise the standard genetic toxicology battery for prediction of potential human risks, and to provide guidance on interpretation of results, with the ultimate goal of improving risk characterisation for carcinogenic effects that have their basis in changes in the genetic material. The revised guidance describes internationally agreed upon standards for follow-up testing and interpretation of positive results in vitro and in vivo in the standard genetic toxicology battery, including assessment of non-relevant findings.

      Implementation :

      Step 5

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      EC, EuropeAdopted by CHMP, December 2011, issued as EMA/CHMP/ICH/126642/2008

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      MHLW/PMDA, Japan Adopted 20 September 2012, PFSB/ELD Notification No. 0920-2

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      FDA, US Published in the Federal Register, 7 June 2012, Vol. 77, No. 110, p. 33748-9

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      Health Canada, Canada Implemented 21 January 2016, File #: 15-114028-981

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