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

We have adopted this International Scientific Guideline – ICH S2 (R1); EMA/CHMP/ICH/126642/2008

Last updated

About this guideline

Overseas effective date:  June 2012

Replaces: Replaces and combines CPMP/ICH/141/95 (ICH S2A) and CPMP/ICH/174/95 (ICH S2B)

Categories: ICH | Safety

Non-clinical | Toxicology | Genotoxicity

TGA annotations: nil

  • Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.
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For more information see International scientific guidelines adopted in Australia.

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