Suisse – Swissmedic updates guidance on temporary medicine authorization to harmonize deadlines

The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on the temporary authorization of human medicinal products.

In the document, Swissmedic outlines the process for seeking temporary authorization, a path to market that allows organizations to sell a medicine for up to two years despite lacking complete documentation. Switzerland uses temporary authorization to accelerate access to treatments for life-threatening diseases, enabling patients to receive therapies while the developer works to meet the full approval requirements.

Swissmedic recently updated its advice on temporary authorizations, publishing version 13.0 of the guidance and revising an associated question-and-answer document. Most of the advice is unchanged, meaning the focus remains on the requirements and submission process for temporary authorization, but Swissmedic has clarified its position on several points…