Thursday, January 11, 2024 10:28:49 AM
For years, the MHRA was in line with the EMA, which has a 210-day accelerated approval process, but some politicians in the UK wanted to show that the MHRA can “lead the world” in rapid approvals after Brexit, so they created the 150-day process (without the 60-day clock-off period). Unfortunately, they didn’t give the MHRA the proper resources or institute the necessary process changes to accomplish this, so it has been unable to meet that 150-day target, and approval timelines have actually been stretched beyond 300 days in many instances, due to staffing and other issues.
So at this point, now that the MHRA has finally hired new assessors and streamlined processes, and regulatory backlogs are being cleared, how fast can the MHRA actually review the application? Can they now assess a high priority application in 150 days total as they once touted? (which would be May)
The MHRA’s Deputy Director, Innovative Medicines, Dr. Shirly Hopper said that many would be happy if they could just meet the 210-day timeline again, which is why I think July seems reasonable, but I certainly leave open the possibility that the MHRA can pull a rabbit out of the hat for Northwest Bio, and approve it more rapidly.
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