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ICH M7 Guideline | Assessment and Control of DNA reactive impurities in pharmaceuticals

August 30, 2023

The European Medicines Agency Committee for Medicinal Products for Human Use published recently a new Question and Answer document, following the publication of Revision 2 of ICH M7 and its addendum on the assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk, with the aim to clarify and address Quality and Safety issues that have been identified from experience through implementation of M7 since its publication in 2014. Clarification on the justification of control strategy for mutagenic impurities in the marketing authorization dossier, organization and depth of information reporting of individual mutagenic impurities, (Q)SAR systems, and other safety-related information are provided.

You can have a look at the complete Q&As document here: ICH M7 Q&As

ICH M7(R2) and its Addendum will come into effect on September 30, 2023.

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