• M7 Genotoxic Impurities

    Code Document Title Previously coded
    • Description :

      The ICH M7 Guideline was finalised in 2014 offering 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 Concern (TTC) and whether the TTC may differ based on differences in the approved duration of use.

      To complement this ICH M7 Guideline an Addendum was finalised in 2017 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.

      Implementation :

      Step 5


      EC, EuropeTo be notified

      FDA, US To be notified

      Health Canada, Canada Implemented 15 January 2016, File #: 15-114011-514

      MHLW/PMDA, Japan To be notified

      Swissmedic, Switzerland To be notified