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Swiss Agency Firms Up Role In Multi-Country Drug Review Scheme

New Guidance Explains Workings Of Project Orbis

 
• By Ian Schofield

Experience gained from pilot participation has convinced the Swiss medicines agency that the collaborative cancer drug review initiative is the way forward.

Coordination, knowledge sharing.
Key regulators are taking part in a collaborative review initiative coordinated by the US FDA • Source: Shutterstock

Switzerland’s drugs regulator has decided to make permanent its participation in Project Orbis, the global initiative that allows simultaneous reviews of new cancer drugs by selected medicines agencies. Swissmedic has also published guidance explaining how the application and review process works.

Project Orbis was launched in September 2019 by the Oncology Center of Excellence of the US Food and Drug Administration to accelerate the approval process for cancer therapies worldwide

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