Thursday, August 24, 2017 4:32:41 AM
Below, 2017 figures. I didn't do other year figures because it's a lot of work.
Average # of Days Between CHMP Recommendation and EMA Approval: 64
Average # of Days Between CHMP Recommendation and EMA Approval (without extreme 90+ days): 58
Minimum Days between CHMP recommendation and EMA approval: 34
Maximum Days (not including 80+ days) between CHMP recommendation and EMA approvals: 78
Maximum Days: 296
Total # of drug approvals in 2017: 56
# of Days that took over 67: 8
# of Days that took under 67: 48
# of Days equal to 67: 0
Breakdown of approval days between CHMP recommendation and EMA/EC (European Commission) approval
# of Days under 30: 0
# of Days 30-39: 1
# of Days 40-49: 6
# of Days 50-59: 19
# of Days 60-69: 22
# of Days 70-79: 5
# of Days 80 and over: 3
# of days of the week count EMA approved a drug in 2017
Mon: 19
Tues: 2
Wed: 17
Thur: 9
Fri: 9
Fact #1: If a drug is refused/not recommended by the CHMP, the company can submit new data and/or request the CHMP redo the review. A reasonable number goes through subsequent times. Some do not.
Fact #2: Of all the drugs which were refused by the European Commission (EC), all were also refused or not recommended by CHMP. To put it in other words, every single drug recommended by the CHMP has been authorized to market by the EC
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