The purpose of this guideline is to provide a practical framework that can be applied for the identification, categorisation, qualification and control of mutagenic impurities to limit potential carcinogenic risk.


This guideline is intended to complement ICH Q3A(R2), 9 Q3B(R2) (note 1), and ICH M3(R2): non-clinical safety studies for the conduct of human clinical trials and marketing authorisations for pharmaceuticals.


Document details

Download document International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – Step 3
Reference number EMA/CHMP/ICH/83812/2013
Status draft: consultation open
First published 22/02/2013
Last updated 16/05/2013
Consultation start date 22/02/2013
Consultation end date 20/06/2013
Email address for submissions

Posted on the EMA website on 16 May 2013