UK Presents New Licensing Pathway For Innovative Drugs
MHRA To Be ‘Enabling Regulator’
A “powerful new vision” for the post-Brexit UK regulatory framework was unveiled at a conference organized by the BioIndustry Association and the medicines regulator, the MHRA.
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A new licensing route is to be introduced by the UK MHRA next year for products that meet specific criteria, such as treating life threatening conditions or rare diseases and where there is a significant patient need. At a webinar this week, an MHRA medical assessor looked at the requirements that products will have to meet to enter the new pathway.
The UK medicines regulator has a “unique opportunity” to evaluate the systems it operates and to “do things differently", according to its long-term interim head, June Raine.
Under EU rules, once a medicinal product has been placed on the market in a country of the EEA – the EU plus Iceland, Liechtenstein and Norway