BRIEF—UK MHRA will join Project Orbis

The UK’s Health Secretary, Matt Hancock, announced on Monday at Conservative Party conference that the Medicines and Healthcare products Regulatory Agency (MHRA) will join Project Orbis, an initiative led by the USA’s Food and Drug Administration Oncology Center of Excellence.

Steve Bates, chief executive of the BioIndustry Association (BIA), said: “This is a welcome move enabling the UK to join an international framework to provide concurrent submission and regulatory review of oncology products, which may allow UK patients with cancer to receive earlier access to medicines in future.

“At present Project Orbis includes the American, Canadian and Australian regulators which the UK will join.

“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.”