Table 3.
Time needed for each (inter)national regulatory approval.
| Country | VHP | EC | NCA | CCA |
|---|---|---|---|---|
| Estonia | 84 | 44 | 111 | 376 |
| Germany | 84 | 149 | 14 | 74 |
| Greece | 84 | 57 | 99 | 52 |
| Hungary | 84 | 87 | 153 | 768 |
| Italy | 84 | 28 | 163 | 193 |
| Netherlands | – | 110 | 21 | – |
| Norway | – | 136 | 91 | 192 |
| Poland | – | 29 | 88 | 531 |
| United Kingdom | 84 | 119 | 8 | 209 |
| Median (IQR) | – | 87 (37–128) | 91 (16–132) | 201 (104–492) |
Notes: Time is displayed in days. The approval time is the time of the first approval (amendments for adding sites are not included).
EC: ethics committee; NCA: National Competent Authority; CCA: Country Coordinator Agreement; IQR: interquartile range; VHP: voluntary harmonisation procedure.