Swissmedic permanently involved in Project Orbis
19 February 2021 – In September 2019, the Oncology Center of Excellence (OCE) of the U.S. Food and Drug Administration (FDA) launched a project called Orbis to accelerate the approval process for new cancer therapies worldwide. In this project, pharmaceutical companies can simultaneously submit their authorisation applications to other participating international regulatory authorities in addition to the FDA. The applications are examined by these authorities in cooperation – and in parallel – with the FDA so that the time frame for a possible authorisation is shortened. Swissmedic already took part in the project by way of a pilot study in 2020. Having evaluated the experience gained, Swissmedic has now decided to participate in Project Orbis on a permanent basis.
For more information, see here.