Information on drug impurities mutagenic potential is often quite limited. Data on mutagenic impurities of drugs developed long time ago is scarce. Nevertheless, modern regulators require mutagenicity studies to be included in registration dossier even if a generic formulation of the widely used drug is undergoing registration. So, pharma industry community has a strong need for guidance on mutagenicity studies and this need is recognized by ICH (International Conference on Harmonization).
To complement the harmonized ICH M7 Guideline (Assessment And Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk), an Addendum has been developed to summarize known mutagenic impurities commonly found or used in drug synthesis.
The ICH M7(R1) Addendum (Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes) reached Step 4 of the ICH process in May 2017 and now enters the implementation period (Step 5). Step 4 stands for the adoption of harmonized guideline with step 5 being final (implementation step).
This addendum should make a preclinical evaluation of different compounds for drug approval application clearer as distinct requirements for different substances are provided in the new addendum.