In an update posted last week, Swissmedic explained some ways in which its requirements for the control of nitrosamine impurities will differ from the EU approach announced in February.
While Swissmedic will apply the same deadlines for risk evaluations, confirmatory testing and changes to authorizations as the EU, it will not apply the same requirements to new marketing authorization applications for products containing biological active substances. For already authorized biological products, “Swissmedic only expects in-depth investigations if risk factors arise from the ingredients or as a consequence of the manufacturing conditions.”
Contrary to EU requirements, Swissmedic will not require documents to be submitted if no risks are identified in the risk evaluation.
The Swiss agency has also adopted the same limits for nitrosamine impurities as the EU, except in the case of metformin preparations. “For metformin preparations, the conditions imposed by Swissmedic continue to apply until further notice in view of the uncertainty surrounding the causes of NDMA contamination.”....[Swissmedic]