Brexit: UK Joining US-Led Project Orbis To Speed Cancer Drug Approvals
Joining the international regulatory collaboration could become a key route for the UK to remain an early and priority market for global launches after the end of the Brexit transition period, says the industry group, BIA.
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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.
Hot on the heels of announcing it was joining Project Orbis, the UK drug regulator, the MHRA, now says it will join another international collaboration that allows drug companies to submit medicines for review by several countries at the same time.
So much will change on the regulatory front next year that the UK drug regulator, the MHRA, has had to issue dozens of new guidance documents to help pharma and biotech firms navigate the new requirements and assessment routes. A key consideration is how the UK will handle centralized EU applications that are still pending on 31 December.