CRED 8 Presentations
01/07/2024
Probability of Success Jan 2016 – Jan 2020
Type
(n) 331
Success
All
88% 97 % 94 % 84 %
Generics
84 32
Biosimilars
Full MAA (excluding generics and biosimilars)
215
With ODD
62
83 % 84 %
Without ODD
153
The Organisation for Professionals in Regulatory Affairs
Data from EMA Annual Report and CHMP Highlights
19
Impact of Orphan Drug Designation 157 Orphan Designations with outcome 2000 – 2013
The Organisation for Professionals in Regulatory Affairs
20
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