ICH M7(R2) Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

We have adopted this International Scientific Guideline - ICH M7 (R2); EMA/CHMP/ICH/83812/2013

Last updated

17 July 2024

About this guideline

Adopted by the TGA: 26 June 2024

Overseas effective date: 30 September 2023

Replaces: ICH M7 (R1); EMA/CHMP/ICH/83812/2013 (adopted by the TGA on 20 February 2020).

Categories: ICH | Multidisciplinary

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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