How To Get A ‘Great Britain’ Drug Approval In 2021
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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The UK MHRA has updated its guidance on how it plans to regulate medicines and healthcare products if the UK leaves the EU without a deal. Among many other things, it includes the promise of free scientific advice for SMEs and details on how marketing applications for centrally authorized products will be converted into UK ones in the event of a hard Brexit.
Two new projects have begun, one on standardizing the assessment of immune responses in individuals vaccinated in clinical trials, the other to improve understanding of potential immunity in patients who have been infected with SARS-CoV-2.