Publication with Swissmedic involvement on the risk assessment of nitrosamine impurities

Scientific article on the development and application of the "Carcinogenic Potency Categorisation Approach" (CPCA) published


With the involvement of experts from Swissmedic, an international working group of representatives of regulatory authorities compiled data and principles that led to the development of a model for the risk assessment of nitrosamines based on chemical structural characteristics. This was published in a scientific journal.

The article describes the principles of the Carcinogenic Potency Categorisation Approach (CPCA) published at the end of 2023. The method makes it possible to standardise the definition of acceptable intakes (AI) for medicinal products, including complex chemical nitrosamine impurities, specifically nitrosamine drug substance-related impurities" (NDSRI). This speeds up safety assessments of nitrosamine impurities.

The open-access scientific publication also uses sample molecules to illustrate how the CPCA is used to determine acceptable intakes for nitrosamine impurities. This allows industry and manufacturing experts in particular to understand the classification into different risk classes.

Not least, understanding the method enables constructive participation in its further development. In conjunction with other measures, the approach should also help to reduce or avoid animal experiments to assess the carcinogenic potential of nitrosamine impurities.