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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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.
New UK guidance on the post-Brexit regulation of medicines says the Medicines and Healthcare products Regulatory Agency will be able to issue its own conditional marketing authorizations next year. The agency has also outlined how drug safety reports should be submitted.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.