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