EMA review, manufacturer response and regulatory review times for 161 novel medicines approved by the EMA between 2001 and 2010, overall and stratified by whether there was a post-market safety event as well as regulatory review time stratified by key medicine and application characteristics
| Median (interquartile range), days | P value | |||
|---|---|---|---|---|
| All medicines | Medicines with safety events | Medicines with no safety event | ||
| EMA review time | 337 (276–406) | 348 (312–401) | 331 (267–412) | P = 0.23 |
| Manufacturer response time | 219 (208–237) | 219 (206–233) | 219 (209–240) | P = 0.93 |
| Regulatory review time | 1143 (70–173) | 117 (86–170) | 112 (61–174) | P = 0.57 |
| Regulatory review time, stratified by key medicine and application characteristics | ||||
| Accelerated assessment pathway | ||||
| Yes (n = 7) | 183 (176–253) | NA | 183 (176–253) | NA |
| No (n = 154) | 341 (295–414) | 348 (313–401) | 337 (288–419) | P = 0.79 |
| Designated by EMA as orphan drug at approval | ||||
| Yes (n = 48) | 348 (274–456) | 337 (274–367) | 359 (269–491) | P = 0.28 |
| No (n = 113) | 337 (276–404) | 349 (316–428) | 330 (267–401) | P = 0.08 |
| Approved in 2005 or later, after implementation of EMA’s risk management plan | ||||
| Yes (n = 100) | 331 (294–399) | 337 (299–371) | 330 (279–411) | P = 0.84 |
| No (n = 61) | 360 (269–426) | 373 (335–449) | 331 (250–413) | P = 0.19 |
| Therapeutic type | ||||
| Small molecule (n = 120) | 337 (276–412) | 337 (295–380) | 331 (267–430) | P = 0.99 |
| Biologic (n = 41) | 360 (284–431) | 373 (328–485) | 331 (269–393) | P = 0.11 |
| Pre-approval safety concern identified by EMA | ||||
| Yes (n = 98) | 358 (295–424) | 344 (316–395) | 365 (269–449) | P = 0.82 |
| No (n = 63) | 330 (268–395) | 365 (276–445) | 329 (267–393) | P = 0.24 |
| Approved by the FDA prior to EMA approval | ||||
| Yes (n = 102) | 334 (268–408) | 358 (316–418) | 329 (267–405) | P = 0.13 |
| No (n = 59) | 360 (302–405) | 341 (306–380) | 367 (292–419) | P = 0.56 |
| Medication’s expected duration of treatment | ||||
| Acute (n = 26) | 334 (290–393) | 380 (343–448) | 315 (268–387) | P = 0.03 |
| Intermediate (n = 45) | 331 (258–393) | 331 (240–366) | 334 (267–412) | P = 0.34 |
| Chronic (n = 90) | 348 (293–439) | 358 (316–428) | 337 (269–449) | P = 0.45 |
EMA, European Medicines Agency; FDA, Food and Drug Administration; NA, not applicable.
*P value for difference in median regulatory review time between medicines for which there was and was not a post-market safety event.
†P for interaction test = 0.04.
‡P for interaction test > 0.10.
§Not applicable because no medicines approved via the accelerated assessment pathway were found to have post-market safety events.