8 October 2020 - The UK is set to join the US FDA's Project Orbis at the start of next year, Health Secretary Matt Hancock said during a speech on how the UK will approach the licensing of medicines after it leaves the European Union.

FDA set up Project Orbis to facilitate concurrent submission and review of cancer drugs among a pool of international regulators.

The US agency worked with its peers in Australia and Canada to review Eisai’s Lenvima in combination with Keytruda last year, marking the first time Project Orbis had been used to support an authorisation. Each agency issued its own label after collaboratively reviewing the application.

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