The Oncology Center of Excellence (OCE) of the U.S. Food and Drug Administration (FDA) launched an initiative under the name “Project Orbis” in September 2019 to accelerate the authorisation process for promising new cancer therapies worldwide.
Under Project Orbis, pharmaceutical companies can submit their authorisation applications to both the FDA and other participating international regulatory authorities at the same time. The relevant applications (type A and certain type B applications) are assessed in parallel by the relevant regulatory authorities in collaboration with the FDA.
The regulatory authorities in the following countries are currently involved in Project Orbis:
- Australia (TGA)
- Brazil (ANVISA)
- Canada (Health Canada)
- Israel (MOH)
- Singapore (HSA)
- Switzerland (Swissmedic)
- United Kingdom (MHRA)
Swissmedic supports Project Orbis in keeping with its strategic objectives. In this way, Swiss cancer patients too can be given faster access to innovative treatments.