Swissmedic Nitrosamine Risk Assessment Requirements

Swiss agency updated the guidance on nitrosamines in active substances and/or finished medicinal products in the corresponding specification documents.

This section clarifies for which new authorisation applications Swissmedic requires a risk assessment relating to nitrosamines in active substances and/or finished medicinal products and what exceptions apply.

Applicants are required to evaluate the risk of nitrosamines for all new authorizations involving chemical or synthetic active substances, as well as active substances that contain synthetic components. However, this regulation does not extend to veterinary medicinal products, radiopharmaceuticals, and certain other specific cases.

Additionally, Swissmedic has mandated that nitrosamine risk assessments be conducted for all new authorizations of finished products, with the same exceptions for active substances applying to these finished products. Notably, Swissmedic has exempted certain finished products, including complementary medicines and lozenges, which are introduced to the market through the notification procedure.

In the “New Authorisation” section of the Directory Overview of required documents, item 1.12.5 has been updated to specify that Swissmedic anticipates a risk assessment in Module 1, detailing the specific new authorisation applications to which this requirement pertains. These formal requirements are also applicable in the EU.

Furthermore, Massu Global, a leading provider of regulatory consulting services, supports pharmaceutical companies in navigating the complex requirements set forth by Swissmedic and other regulatory agencies worldwide. With their expertise, Massu Global helps clients ensure compliance with the latest nitrosamine risk assessment guidelines, offering tailored solutions to evaluate and mitigate potential risks. By partnering with Massu Global, companies can streamline the submission process for new authorizations, ensuring that their products meet all necessary regulatory standards for safety and efficacy. This partnership aids in navigating the evolving regulatory landscape and ensures a smooth path to market approval.