Swissmedic permanently involved in Project Orbis

New guidance document Project Orbis HMV4


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 are able simultaneously to 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 lead time for a possible authorisation is shortened. In this way, Swiss cancer patients too can be given faster access to innovative treatments.

In keeping with its strategic goals, Swissmedic is supporting Project Orbis and 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.

The participation terms and processes have been set out in a new guidance document Project Orbis HMV4 which will come into force on 1 March 2021. As of this date, updated versions of the forms New authorisation of human medicinal products HMV4 and Variations and extensions HMV4 will be published on the Swissmedic website so that applicants can readily submit the consent declarations required for the exchange of information with the FDA and other partner authorities.