8 March 2024 – In its decision of 29 January 2024, the Federal Administrative Court partially upheld the appeal against the decision taken by Swissmedic against A. AG concerning the authorisation requirements for medicinal products respectively the rejection of an application for authorisation of a medicinal product for the treatment of acne (B.).

The court discussed the authorisation requirements for medicinal products pursuant to Art. 11 et seq. Therapeutic Products Act (TPA) and Art. 9 et seq. Ordinance on Medicinal Products (Arzneimittelverordnung, VAM).

Regarding the complaint that Swissmedic had interpreted the requirements for the clinical trial of B. too strictly, the court concluded that this complaint was partially justified. The court noted that Swissmedic required the appellant to conduct a phase 3 trial to obtain marketing authorisation for B. These studies are complex and expensive and are generally only required for new medicines with a new mechanism of action. However, the court does not consider it justified to require a phase 3 trial for the approval of B. B. contains two active ingredients that are already approved individually for the treatment of acne. Although the combination of these active ingredients is new, there are already several studies demonstrating the efficacy and safety of this combination.

The court therefore concluded that the studies submitted by the appellant were sufficient to demonstrate the efficacy and safety of B. It concluded that Swissmedic had interpreted the requirements for the clinical trial of B. too strictly. The studies submitted by the appellant were sufficient to demonstrate the efficacy and safety of B.

The court therefore concluded that Swissmedic had been wrong to refuse to authorise B. It upheld the appeal in part and instructed Swissmedic to re-examine the appellant's documents and take a revised decision.

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