21 June 2017

The ICH M7(R1) Addendum reached Step 4 of the ICH process in May 2017 and now enters into the implementation period (Step 5).

To complement the harmonised ICH M7 Guideline, an Addendum has been developed to summarise known mutagenic impurities commonly found or used in drug synthesis. The intent of this Addendum is to provide useful information regarding the acceptable limits of known mutagenic impurities/carcinogenic and supporting monographs.

The ICH M7(R1) Guideline (including the adopted Addendum) is available for download on the Multidisciplinary Guidelines page of the ICH website.