Europe – Euro Roundup

The UK is set to join the US Food and Drug Administration’s (FDA) 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 authorization. Each agency issued its own label after collaboratively reviewing the application.

The UK decided to join the project as the Medicines and Healthcare products Regulatory Agency (MHRA) will lose the ability to collaborate with EU countries on drug assessments next year. MHRA’s participation will potentially accelerate access to some cancer drugs in the UK by allowing companies to gain approval while targeting the far larger US market.

“Since nearly all innovative oncology products are launched in the USA, this new regulatory path may become a key route by which the UK remains an early and priority market for global launches, after the end of the transition period,” said Steve Bates, chief executive officer of the UK Bioindustry Association…