The International Council for Harmonisation (ICH) earlier this week announced the adoption of its M7(R2) guideline that aims to harmonize the framework for assessing and controlling DNA mutagenic impurities in pharmaceuticals as well as an addendum listing the 21 impurities that should be tested along with their daily permissible limits (PDEs). Both were adopted on 3 April.
“The focus of this guideline is on DNA reactive substances that have a potential to directly cause DNA damage when present at low levels leading to mutations and therefore, potentially causing cancer,” ICH wrote. “This type of mutagenic carcinogen is usually detected in a bacterial reverse mutation (mutagenicity) assay.”
The adopted guideline is little changed from the draft, with the addendum incorporating the seven additional DNA reactive compounds that were earlier proposed for inclusion, bringing the total to 21 mutagenic impurities (RELATED: ICH guideline proposes daily limits for seven mutagenic impurities, Regulatory Focus, 8 October 2021)…
