28 November 2011

The ICH S2(R1) Guideline on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use reached Step 4 of the ICH Process in November 2011 and now enters the Implementation phase (Step 5).

This revised guidance replaces and combines the ICH S2A Guideline: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals and the ICH S2B Guideline: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals.

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.

The final Guideline is available for download under the Safety Guideline page.