Switzerland – Swissmedic mandates nitrosamine risk assessments in some applications

The Swiss Agency for Therapeutic Products (Swissmedic) has updated guidance on nitrosamines to clarify when new authorization applications must include a risk assessment.

Swissmedic added a section on nitrosamine risk assessments for active substances and finished products to its formal requirements guidance. The section features a table that lists compulsory requirements for active substances and finished products, plus exceptions to the rules…