FDA Adopts Final ICH M7(R1) Mutagenic Carcinogen Guideline

Potential or actual impurities in drugs should be studied for their mutagenic properties, according to a revision to an ICH guideline addendum on mutagenic carcinogens, now adopted by the FDA.

Finalized by the ICH in May 2017, the M7(R1) guideline examines acceptable levels of impurities in DNA-reactive substances that could potentially cause damage or increase the risk of cancer when present at low levels.

Assessing impurities involves identifying those that have already been identified — to consider their mutagenic potential — and assessing impurities that could potentially be present in the final substance to determine whether further analysis is necessary. This can include impurities in starting materials, reagents and intermediates, in the route of synthesis from starting material to drug substance.