Project Orbis – Process for efficient submission and assessment of innovative oncology medicines

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.

The participation terms and processes have been set out in the Guidance document Project Orbis, which entered into force on 1 March 2021. The forms New authorisation of human medicinal products and Variations and extensions were updated at the same time, meaning that applicants can readily submit the consent declarations required for the exchange of information with the FDA and other partner authorities. The FDA is responsible for overall coordination of the selection of applications. Initial enquiries should be sent to the FDA.

Supplementary information

Swissmedic has been involved in Project Orbis since 2020, initially as part of a pilot project. Following evaluation of the experience gained, Swissmedic decided in 2021 to participate in Project Orbis on a permanent basis.

Last modification 06.06.2024

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