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

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

Document history - Superseded documents

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

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

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

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