The ICH M7 Q&A document on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” reached Step 2b of the ICH Process on 29 June 2020 and now enters the consultation period.
The ICH M7 Q&A document on “Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk” reached Step 2b of the ICH Process on 29 June 2020 and now enters the consultation period.