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0902 BtS13 China Japan iterate
BioCentury

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China and Japan raise the bar on expedited approvals, adding time limits

Iterating on FDA, EMA expedited approvals with stricter requirements for postmarket data submissions

China and Japan have iterated on FDA, EMA expedited approvals with stricter requirements for postmarket data submissions.

Sep 2, 2021 | 1:21 PM GMT

China and Japan have taken the expedited drug approval pathways in the U.S. and Europe, and tightened one of the loosest provisions: the time taken to deliver data from the postmarket confirmatory trials.

Though the median time is about three years for converting accelerated and conditional approval pathways to full approvals in the U.S. and Europe, the elapsed time has ranged from less than a year to over 10.

The variability, plus inconsistency from FDA in requiring the data, and companies in providing

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