Swissmedic: Specialist Group for Nitrosamine Issues
On 1 July 2023, the new "Nitrosamines Specialist Group" of the Swiss regulatory agency Swissmedic started its work, as announced in May. The group is divided into a coordination office and a centre of expertise for all issues regarding nitrosamines.
The coordination office emerged from a former task force on the subject. It is the central and single point of contact.
The centre of expertise is formed out of members from various different specialist divisions and is meant
- to provide a technical assessment with regard to physico-chemical and toxicological evaluations of nitrosamines,
- to coordinate the exchange of information between manufacturers and international partner authorities, and
- to represent the agency in international panels.
With the introduction of the expert group, Swissmedic is strengthening its focus on the ongoing issues surrounding nitrosamines and is promoting both exchange and cooperation at international level, as well as the coordination of the risk-benefit analyses in the case of new authorisations and in the case of market surveillance.
Source:
Swissmedic: Nitrosamine impurities
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