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Re: ae kusterer post# 659298

Tuesday, 12/26/2023 3:21:20 PM

Tuesday, December 26, 2023 3:21:20 PM

Post# of 708448

Apologies for this question.I have seen the answer posted on ihub in '23. "from the time of an maa filing, what is the mean tine to acceptance? " Also, range, please.



The latest MHRA performance report is here.

The first few slides are just on variations, not new drug approvals.

The New Active Substance (NAS) approval slides start on page 10.

There is no absolute breakdown by each approval, but it is by month. Almost all are over 300 days. And if you go to the next slide that excludes ORBIS you will see that all are over 300 days.

These are the MHRA slides. So if anybody disagrees, take it up with them.

BTW, if you go down to slide 12 you will see the stats on "reliance": approvals. These are when the MHRA rubber stamps an EMA approval. Those are much faster, and what many here assert as the timeline.
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