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

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Current effective version

Revision 1 - Adopted guideline

Reference numberCHMP/ICH/126642/08
Published01/12/2011
Effective from01/06/2012
KeywordsGenotoxicity, standard test battery, in vitro test, in vivo test, results interpretation
DescriptionThis 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.


Document history

Revision 1 

Current version

Adopted guideline

In operation: 01/06/2012–present

Superseded documents

Adopted guideline (ICH S2A)


Adopted guideline (ICH S2B)

In operation: 01/04/1996–31/05/2012


In operation: 01/03/1998–31/05/2012


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