The speed at which various therapies progressed through the maa process has been an evolving regulatory condition since Brexit.
First, it was the EMA with its headquarters in England, but by January 2020, yes, the same year Covid dominated the world, and by the end of that year, with the EMA headquarters moved from England, and the UK just getting its sea legs, on December 2, 2020, MHRA approved the first COVID Vaccine over the course of a few months.
During and since that time, MHRA CEO June Raine shepherded the UK through massive transition.
Initially, as Exwannabe loved to point out, it was not a given MHRA would handle independent MAAs for new therapies, that is, until the COVID vaccine approval at the end of 2020, made it clear the MHRA did not intend to be a bystander.
Since that time, the MHRA was inundated with backlogs and overworked employees trying to bust sod and determine ways to reinvent their
Business model. One of the breakthroughs was the International Recognition Program. By fully implementing this at the start of 2024, the MHRA, in the course of this year, worked through massive backlogs to the point where it appears by January or February 2025, they will start hitting target dates for every subcategory of MAAs.
During that time, and particularly over the last few months, MHRA have developed and tweaked a one page performance review so the public can easily see progress from month to month.
People might think such positive change could only be effected with a quasi dictatorship taking over government strings, not in a democracy, but the MHRA stood to prove them wrong.
It may be painful to know that NWBO was placed in a cue like everyone else (excepting the Covid vaccines), and subject to delay like everyone else, but it is nonetheless remarkable the progress made and being completed before, during and after Brexit.
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