Table 1.
Characteristics of the 161 novel medicines approved by the EMA between 2001 and 2010, including the prevalence of post-market safety events stratified by key medicine and application characteristics
| Characteristics | n (%) | Post-market safety event (%) |
|---|---|---|
| Overall cohort | 161 (100%) | 49 (30.4%) |
| Year of approval | ||
| 2001–2005 | 61 (37.9%) | 21 (34.4%) |
| 2006–2010 | 100 (62.1%) | 28 (28.0%) |
| Therapeutic type | ||
| Small molecule | 120 (74.5%) | 35 (29.2%) |
| Biologic | 41 (25.5%) | 14 (34.2%) |
| First regulator to approve | ||
| FDA | 102 (63.4%) | 35 (34.3%) |
| EMA | 59 (36.7%) | 14 (23.7%) |
| Expected duration of treatment | ||
| Acute | 26 (16.1%) | 9 (34.6%) |
| Intermediate | 45 (28.0%) | 17 (37.8%) |
| Chronic | 90 (55.9%) | 23 (25.6%) |
| Orphan designation | ||
| Yes | 48 (29.8%) | 14 (29.2%) |
| No | 113 (70.2%) | 35 (31.0%) |
| Accelerated assessment procedure | ||
| Yes | 7 (4.3%) | 0 (0%) |
| No | 154 (95.7%) | 49 (31.8%) |
| Pre-approval safety concern | ||
| Yes | 98 (60.9%) | 35 (35.7%) |
| No | 63 (39.1%) | 14 (22.2%) |