EMA consultation: ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk – Q&A
The European Medicines Agency has published for public consultation the ICH guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk - questions & answers. The guideline is available at this link. Since the ICH M7 Guideline was finalized, worldwide experience with implementation of the recommendations for