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‘Innovation Passport’ Necessary For UK Project Orbis Reviews

MHRA Specifies Prerequisites For International Oncology Drug Review Initiative

 
• By Vibha Sharma

Promising cancer medicines will need to be included in the UK’s new licensing pathway for innovative drugs before the UK medicines regulator will agree to their review under the Project Orbis initiative.

Digital illustration of Cancer cell in colour background
Project Orbis Allows Concurrent Review Of Cancer Drugs By International Partners • Source: Shutterstock

Cancer drug manufacturers will have to fulfil certain additional criteria if they want their products to be evaluated by the Medicines and Healthcare products Regulatory Agency under Project Orbis when the UK regulator formally joins the US-led medicines review initiative next year.

Project Orbis allows participating international regulators to simultaneously review promising oncology medicines faster than otherwise possible. Regulators from Australia, Canada, Singapore, Switzerland and Brazil already participate, and the UK will become a partner on 1 January

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