Nitrosamine impurities in medicinal products: Swissmedic sets up specialist group

“Nitrosamine Specialist Group”: centre of expertise and coordination office for nitrosamine issues


The Swissmedic Management Board decided in May 2023 to set up a “Nitrosamine Specialist Group” from 1 July 2023. The centre of expertise, which comprises members from different specialist divisions, will ensure specialist expertise on physico-chemical and toxicological assessments of nitrosamines, coordinate expert exchange with manufacturers and international partner authorities, and represent Swissmedic in specialist international bodies. The Specialist Group, which emerged from the previous taskforce, is the coordination office and single point of contact for nitrosamine questions.

Since nitrosamine impurities in antihypertensive medications in the sartans substance class became known in July 2018, a Swissmedic working group has been investigating the causes and, together with international partner authorities, been advising what medicinal product manufacturers should do to prevent these potentially carcinogenic impurities.

Thanks to increasingly sensitive analysis methods, nitrosamine impurities have also been identified in other medicinal products and active substances following the sartans, and the affected batches have been recalled. In September 2019, for example, Swissmedic recalled all medicinal products containing the active substance ranitidine, because they contained traces of a nitrosamine above the internationally tolerated safety limit for medicinal products. The therapeutic products authorities in the USA, Canada, Europe, Singapore and Australia have also since expanded their investigations on ranitidine and other potentially affected active substance groups, and ordered batch recalls.

On 15 November 2019, Swissmedic detailed to authorisation holders of human medicinal products the procedure to follow in order to be able to control and limit the concentrations of nitrosamine impurities in medicinal products. In mid-September 2022, Swissmedic provided information on current regulatory and scientific developments. The requirements for dealing with potentially genotoxic impurities in medicinal products have been agreed at international level where this is scientifically expedient and possible within the provisions of the differing therapeutic products legislation between countries.

Through the new Specialist Group, Swissmedic is strengthening the exchange of information and knowledge on the nitrosamine issue in medicinal products, stepping up international collaboration and coordinating benefit-risk analyses for new authorisations or as part of market surveillance.

Nitrosamines occur in food products, cosmetics and everyday objects and can even be formed in the body itself. The traces detected in medicinal products are far lower than the quantities that are consumed in foodstuffs depending on diet. However, the precautionary principle applies: whenever possible, none of these substances, which may be carcinogenic at high concentrations, should be consumed. Batches of medicinal products containing levels of impurities above the international safety limits are therefore regularly recalled worldwide.

Swissmedic has requested that all authorisation holders of medicinal products with chemical-synthetic active substances (APIs) take precautionary measures to reduce the risk of nitrosamine contamination. Impurities that are potentially carcinogenic at high concentrations are to be reduced to an absolute minimum.

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