7 February 2013

The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 2 of the ICH Process in February 2013 and now enters the consultation period (Step 3).

This new Guideline is proposed to offer guidance on analysis of structure activity relationships (SAR) for genotoxicity. Furthermore, it is intended to resolve questions such as whether impurities with similar alerts that potentially have similar mechanism of action should not be combined in calculating a Threshold of Toxicological (TCC) and whether the TTC may differ based on differences in the approved duration of use.

The draft Guideline is now available for download under the Multidisciplinary Guideline page.

You are invited to provide comments on the draft Guideline by e-mailing the ICH Secretariat. More details under the Open Consultation page.

Note that stakeholders from EU, US and Japan are encouraged to submit their comments to their respective Regulatory Authorities.