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Europe: Swissmedic updates nitrosamine impurity evaluation requirements

2022/09/22  SwissMedic

Swissmedic is harmonising the requirements for dealing with nitrosamine contamination in medicinal products with those in the European environment as far as this is scientifically reasonable and is possible within the provisions of Swiss therapeutic products legislation.

As already detailed in previous publications, Swissmedic is aiming to harmonise requirements with those of the European environment. Since Swissmedic’s publication of 16 April 2021 on nitrosamines, the EMA has published a number of updates to its questions and answers document. Swissmedic is therefore also updating its requirements based on the latest version of this document and adopting major revisions published by the EMA.

Implementation will be carried out within the valid provisions of therapeutic products legislation. Specific requirements of Swiss healthcare may entail deviations from the EMA’s approach. Such deviations or clarifications Swissmedic deems necessary are published in the following table and will be updated on an ongoing basis.

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