The ICH M7(R2) Guideline on the “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” and the accompanying M7(R2) Addendum “Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes” have reached Step 4 of the ICH Process on 3 April 2023.
In addition, ICH publishes the accompanying “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” Questions and Answers which were adopted on 24 May 2022 to provide additional clarification, promote convergence and improve harmonization of the considerations for assessment and control of DNA reactive (mutagenic) impurities found in ICH M7(R2).
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