15 December 2025
Swissmedic: Change to Review Practice for Specific Medicinal Products
Swissmedic is adapting its review practice for new applications for medicinal products containing paclitaxel as paclitaxel albumin in line with a new product-specific guideline issued by the European Medicines Agency (EMA), which will enter into force on 1 January 2026. Swissmedic is already applying the principles of this guideline, allowing a clinical bioequivalence study to be waived where robust analytical comparative data demonstrate quality and equivalence.
For more information, see here.
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