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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Promising cancer medicines will need to be included in the UK’s new licensing pathway for innovative drugs before the UK medicines regulator will agree to their review under the Project Orbis initiative.
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.