BIA responds to Health Secretary announcement that the MHRA will join Project Orbis
The Health Secretary, Matt Hancock MP, has announced today in the House of the Commons that the MHRA (the UK medicine regulator) will join Project Orbis, an initiative led by the USA’s Food and Drug Administration Oncology Centre of Excellence.
Steve Bates OBE, Chief Executive of the 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.”