New UK Drug Assessment Routes Among Latest Measures For No-Deal Brexit
Executive SummaryThe 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.
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Regulations that would allow the UK MHRA to work as a standalone regulator in the event of a no-deal Brexit have been laid before parliament. They cover a host of areas including new drug approval procedures, conversion of existing EU marketing authorizations into UK ones, pediatric and orphan exclusivities, imported medicines, and regulatory fees.
The BioIndustry Association wants the government to rule out a “no-deal” Brexit, saying it would be bad for patients and the life sciences sector.