How To Get A ‘Great Britain’ Drug Approval In 2021
New Guidance Attempts To Explain Complexities Of Post-Brexit Regulation
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.
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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.
England’s health technology appraisal body, NICE, and the UK medicines regulator, the MHRA, are working together to align their process timelines so that access to medicines is “maintained and enhanced.”
The UK’s approach to pharmacovigilance system requirements in the post-Brexit transition period will allow companies to leverage some of the existing structures put in place for EU systems.