Wednesday, November 06, 2024 10:17:46 AM
THIS. I have been amused at the charlatans who attempt to denigrate the MHRA as if submitting to them was seeking approval from a second rate health authority. No one should buy the lie that they are held in anything but the highest esteem.
There is nothing wrong with the MHRA wrt the quality of the organization, and I have never heard anybody suggest otherwise.
That it has been slow is a fact. Had they submitted to the FDA in late Dec and been given a priority review the PDUFA date would have been late June. The FDA has been fairly regularly meeting the date, and often ahead of schedule. Resources matter.
The other point is that the UK market is not as large as US or EU, and is challenged by a very tough NICE pricing policy. That does not make it a market that many go to first.
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