At a meeting with the Oncology Center of Excellence (OCE) of the FDA, the American regulatory authority, Swissmedic discussed how it can collaborate on parallel reviews for oncology products. Together with the other members of the ACSS Consortium, i.e. the Australian Therapeutic Goods Agency (TGA), Health Canada (HC) and the Health Sciences Authority (HSA), Swissmedic is taking part in Project Orbis, a pilot project designed to give patients in multiple countries the fastest possible access to innovative cancer treatments.
Pilot project for parallel reviews for the authorisation of innovative cancer drugs
In mid-February 2020, Swissmedic representatives and an FDA delegation headed by Dr Richard Pazdur, Director of the OCE, discussed how Swissmedic can be incorporated in Project Orbis. The aim of the international collaboration is to review applications for innovative first authorisations or indication extensions for oncology products in parallel so that these medicinal products can be made available sooner to patients outside the USA.
Swissmedic supports the initiative in accordance with its strategic objectives for the period 2019–2022. Together with the Australian Therapeutic Goods Agency (TGA), Health Canada (HC) and the Health Sciences Authority (HSA) in Singapore, Swissmedic is taking part in a pilot trial. So far two applications for new indications for existing authorised oncology products have been approved transnationally in connection with Project Orbis by the FDA, TGA and HC. The plan for the future will be to review applications for the authorisation of new active substances (NAS) as well as new indications.
On conclusion of the pilot phase, the situation can be evaluated to determine whether Swissmedic can continue this collaboration on Project Orbis permanently. During the pilot phase, Swissmedic ensures that all authorisation applications are processed within the specified timelines.
On 17 September 2019, the FDA presented a project named Orbis for accelerating the authorisation process for new cancer drugs worldwide. The Oncology Center of Excellence (OCE) is responsible for this initiative. The aim is to give patients faster access to innovative treatments through the simultaneous submission and review of authorisation applications in the participating countries.