REGULATORY

ICH M7 Guideline Reaches Step 4; MHLW to Issue Notification

July 22, 2014
The Ministry of Health, Labor and Welfare (MHLW) announced on July 17 that the ICH M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk reached Step 4 of the ICH Process…

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