Unlike nitrosamines with a simple structure, there are no specific experimental data on NDRSIs that would enable determination of the carcinogenic potential. For this reason, the Carcinogenic Potency Categorization Approach (CPCA) was developed. Based on a structural comparison with nitrosamines with known carcinogenic potential, risks can be identified and, on the basis of the chemical structure, safe intakes can be defined. The total points are calculated on a decision tree, which then results in the risk category for the relevant substance.
Swissmedic is prioritising measures for the CPCA categories that have the highest potential risks to patient safety: Marketing authorisation holders must identify preparations with the potential to form NDSRIs in CPCA categories 1 and 2 by 31 January 2024.
Preparations from CPCA categories 1 or 2 must be analysed using validated and sufficiently sensitive methods. The results of these tests must be provided to Swissmedic by 30 September 2024.
Q&A is also updated.
As required for marketed products, confirmatory testing data are expected if N-Nitroso derivatives of the API (i.e. the directly nitrosylated API) of CPCA Cat.1 or 2 can theoretically form. However, if experimental evidence shows that the N-Nitroso derivative of the API is unlikely to form, the MAH/applicant should contact Swissmedic to clarify if analytical data are required.