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.
Coronavirus Notebook: EMA Probes Janssen Vaccine Blood Clot Reports, UK Advises 12-Week Dosing Gap For Moderna
The AZ vaccine is now under EU scrutiny over capillary leak syndrome, while Valneva has reported positive results with its product. The global COVAX initiative has delivered more than 38 million doses of vaccines to over a hundred countries.