Saturday, 21 November 2020

ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities


 

The EMA has published a listed of responses received in relation to the draft guidance on DNA reactive (mutagenic) impurities. The full title of the document is “Overview of comments received on ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - questions & answers (EMA/CHMP/ICH/321999/2020).”

 

In relation to the document, mutagenic potential refers to the ability of a compound to induce point mutations (i.e., bacterial reverse mutation assay), while genotoxic potential refers to both mutagenic and clastogenic potential.

 

The document can be accessed here: https://www.ema.europa.eu/en/documents/comments/overview-comments-received-ich-guideline-m7-assessment-control-dna-reactive-mutagenic-impurities/chmp/ich/321999/2020_en.pdf

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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