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May 29, 2015.
FDA has released guidance on limiting the risk of carcinogenics due to DNA reactive (mutagenic) impurities in pharmaceuticals. The guidance provides a framework for the identification, categorization, qualification, and control of mutagenic impurities. The guidance is meant to complement International Conference on Harmonization’s (ICH) Q3A Impurities in New Drug Substances (Revision 2) and Q3B (R2) Impurities in New Drug Products documents, which address impurities in new drug substances, and M3 (R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals, which discusses safety studies for clinical trials and marketing authorization.
According to the guidance, it “emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk.” The guidance also provides recommendations for assessment and control of mutagenic impurities “that reside or are reasonably expected to reside in final drug substance or product, taking into consideration the intended conditions of human use.”
While intended for new drug substances and new drug products in clinical development, the guidance also applies to postapproval submissions of marketed products and new marketing applications for drug substances in previously approved products. The guidance does not apply to drug substances or products intended for advanced cancer indications defined in ICH S9 or in cases where a substance is genotoxic at therapeutic concentrations and may be associated with an increased cancer risk.