10 July 2015

The Addendum of the ICH M7 Guideline reached Step 2b of the ICH Process in June 2015 and now enters the consultation period (Step 3).

The M7 Addendum has been developed to complement the harmonised ICH M7 Guideline, which was finalised in June 2014, and to provide useful information regarding the acceptable limits of known mutagenic impurities/carcinogenic and supporting monographs.

The draft M7 Addendum can be downloaded on the Multidisciplinary Guideline page on the ICH website (Draft Addendum document). 

You are invited to provide comments on the draft M7 Addendum by e-mailing the ICH Secretariat. More details under the Open Consultation page.

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