Swissmedic: Nitrosamine Requirements updated

Recommendation

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Swissmedic's nitrosamine Q&A document "Update of the requirements for dealing with nitrosamine impurities in medicinal products" was updated in January 2024 and is now available in the new version on the Swissmedic website. The updates are marked in red in the text.

In the latest version, the answers to the questions in the section "Marketing authorisation processes" have been updated and presented as follows

Answer to 2 preceding questions:

MAHs/Applicants of all human medicinal products should ensure that the presence of nitrosamines is controlled and kept as low as possible. A risk assessment should be submitted for all medicinal products containing chemically synthesised APIs (see EMA Q&A 7). The risk assessment should include the assessment of NDSRIs. Any identified or known risk will require additional data irrespective of the CPCA category. Acceptable intakes for nitrosamine impurities in generic products will be the same as for the originator. Requirements for nitroso derivatives of APIs of CPCA Cat. 1 and 2 will be communicated in due time. 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.

Furthermore, general information regarding the risk assessment for NDSRIs (Nitrosamine Drug Substance-Related Impurities) is provided again on the Swissmedic website in the "General information" section. This includes, for example, the information that substances with the potential to form NDSRIs of CPCA categories 1 and 2 must be identified by the end of January 2024. Authorisation holders are now required to analyse these substances sufficiently and report the results of these analyses to Swissmedic by the end of September 2024.

The updated Q&A catalogue and the information text for nitrosamines in the "General information" section can be viewed on the Swissmedic website.