The ICH has published a draft guideline for comment on the determination and the control of DNA reactive (mutagenic) impurities in medicinal products. The guideline is entitled: "M7: Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk".
Guidelines on genotoxic impurities already exist. For example:
Unfortunately, all these regulations are inconsistent. They partly describe different approaches to the assessment of the genotoxic potential of impurities, or only give unprecise recommendations. There exists no regulation of the topic in the Japanese economic area.
Facing this unsatisfactory situation, the ICH has elaborated a guideline which should provide support and concrete specifications, and - among other things - should clarifiy the following points:
The draft guideline deals with these questions and gives recommendations to them. The topic of changes with regard to the API, the finished product and the clinical applications after post approval changes is mainly discussed. A detailed discussion about control strategies in the context of life-cycle management is also precisely described.
The scope of this guideline covers new APIs and medicinal products during their clinical development. In cases of post approval submissions the guideline can only be used where:
The guideline doesn't apply to:
The draft of the "M7" Guideline was published for comment on 7 February 2013 on the ICH website as a "Step 2 Document". No consultation deadline has been determined yet.