ICH Moves Genotoxic Impurities Guideline to Consultation

July 13, 2015
BioPharm International Editors

The International Conference on Harmonization has moved ICH M7(R1) Addendum to 3 of the ICH process.


The International Conference on Harmonization (ICH) has moved the ICH M7(R1) Addendum to the consultation period of the ICH process. The addendum, which was finalized in June 2014, summarizes commonly found mutagenic impurities in drug synthesis. Comments on the draft addendum can be emailed to the ICH Secretariat. ICH recommends that stakeholders from the European Union, United States, Japan, Canada, and Switzerland submit their comments to their respective regulatory authorities.

The addendum to M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk provides acceptable limits of known mutagenic impurities and supporting monographs. The addendum includes compounds “in which the primary method used to derive acceptable intakes for carcinogens with a likely mutagenic mode of action is the ‘default approach’ from ICH M7 of linear extrapolation from the calculated cancer potency estimate, the TD50. Compounds are also included which highlight alternative principles to deriving compound-specific intakes.”

Source: ICH