ICH S2 (R1) Genotoxicity testing and data interpretation for pharmaceuticals intended for human use - Scientific guideline

This document aims to optimize the standard genetic toxicology battery for prediction of potential human risks. It 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. This guidance does not apply to biologics.

Keywords: Genotoxicity, standard test battery, in vitro test, in vivo test, results interpretation

Current effective version

ICH guideline S2 (R1) on genotoxicity testing and data interpretation for pharmaceuticals intended for human use - Step 5

AdoptedLegal effective date: 01/06/2012Reference Number: EMA/CHMP/ICH/126642/2008

Document history - Superseded documents

S 2 A: Note for guidance on genotoxicity: Specific aspects of regulatory genotoxicity tests for pharmaceuticals

AdoptedLegal effective date: 01/04/1996Reference Number: CPMP/ICH/141/95

S 2 B: Note for guidance on genotoxicity: A standard battery for genotoxicity testing of pharmaceuticals

AdoptedLegal effective date: 01/03/1998Reference Number: CPMP/ICH/174/95