ICH M7 Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/ICH/83812/2013
Effective from01/02/2018
KeywordsImpurities, genotoxicity, mutagenic, carcinogenic
DescriptionThis guideline emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use.

Document history

Second version
Current version
Adopted guidelinePublished: 21/07/2017
Effective from: 01/02/2018
First versionAdopted guideline
In operation: 01/01/2016–31/01/2018

Superseded version


Adopted guideline

Questions and answers

In operation: 01/01/2007–31/12/2015

Published: 19/10/2010

Related documentApplication of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes - Step 2bPublished: 04/08/2015

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