ICH M7 Guideline entering implementation period (Step 5)

The ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 4 of the ICH Process in November 2013 and is now entering the implementation period (Step 5). The final draft is being recommended for adoption to the regulatory bodies of the three ICH regions European Union, Japan and the USA.

The purpose of this new ICH Guideline is to offer guidance on analysis of structure activity relationships (SAR) for genotoxicity. It is also intended to resolve highly complex 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 Concern (TTC) and whether the TTC may differ based on differences in the approved duration of use.

The document is applicable for new drug substances and new drug products during their clinical development and subsequent applications for marketing. Due to the complexity of the guideline, implementation of M7 in the respective national rules and regulationsis not expected prior to 18 months after ICH publication.However, there are some exceptions like: For conducting the Ames test, the specifications of M7 need to be applied immediately.