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Re: hoffmann6383 post# 611132

Tuesday, 07/18/2023 12:21:16 PM

Tuesday, July 18, 2023 12:21:16 PM

Post# of 822029
The most recent version is a bit easier to understand.

MHRA performance review H1 2023

Chart on page 10 is for decisions made by MHRA w/o reliance on CHMP or ORBIS/ACCEES participation. About 400 days from validation to decision.

The charts on page11 is where you see faster times, but that is when they are relying on a CHMP positive decision and no need to do the hard work..

EDIT: BTW, the chart on page 10 also notes that the EMA only approved 2 NAS submission not relying on others in H1. That is solid blue line that shows 1 (the right scale) in both Marck and May and 0 all other months. The "fast" one took about 1 calendar year from validation..
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