Swissmedic is shortening the procedural time limits for applications for additional indications according to Orbis type A and fast-track Orbis type B.
This change is part of the continuous further development of the Project Orbis procedure and should help further enhance the attractiveness of the international procedures. The new time limits will expedite the processing of applications for additional indications for Orbis type A and fast-track Orbis type B procedures, thereby giving patients faster access to innovative medicinal products.
Swissmedic has revised the guidance document Time limits for authorisation applications accordingly. The new time limits for applications for additional indications in Orbis type A and fast-track Orbis type B come into effect on 1 June 2025.