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.
You may also be interested in...
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.
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.
The mRNA-1273.214 vaccine will add to the UK’s armory for protecting people against coronavirus over the coming winter season.