Table 1 The number of orphan drug designations and approvals in U.S., EU, Japan and China
From: The availability and affordability of orphan drugs for rare diseases in China
Regions (Time range) | Number of orphan drug designations | Number of orphan drug approvals for marketing | Number of unique orphan drugs approved for marketinga (A) | Number of unique orphan drugs marketed in Chinaa (B) | Market availability rate in China [(B)/(A) × 100 %] |
|---|---|---|---|---|---|
U.S. (1983–2012.12.31) | 2741 | 425b | 315 | 119 | 37.8 |
EU (2000–2012.12.31) | 1098 | 65 | 65 | 16 | 24.6 |
Japan (1993–2012.12.31) | 300 | 185c | 145 | 76 | 52.4 |
Total | 4132 | 675 | 525 | 211 | 40.2 |
408a | 165a | 40.4 |