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How To Get A ‘Great Britain’ Drug Approval In 2021

New Guidance Attempts To Explain Complexities Of Post-Brexit Regulation

 
• By Ian Schofield

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.

Roadsign_Gov_Regulations
A raft of new medicine regulations is on the way • Source: Shutterstock

The UK regulatory body, the MHRA, has told pharmaceutical companies that they will have two options if they want to obtain a new “Great Britain marketing authorization” for drugs that have been filed at EU level but are still awaiting a decision when the Brexit transition period expires at the end of this year.

In new guidance issued on 1 September, companies are informed that they can choose between an MHRA assessment that is separate from, but parallel with, the ongoing EU evaluation process,...

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