Tables on assessment times for new national applications in 2023
Updated 04 March 2024
Table 1. Total time for completed cases
| Total assessment times for closed cases | Average assessment time | Target days for full/abridged applications | Difference between assessment time and target days | No. of cases measured No. of drug Ids |
No. of cases within target | Share of cases within target in per cent |
| 4th quarter 2021 | 227 | 240 | -13 | 3 | 3 | 100 |
| 1st quarter 2022 | 215 | 240 | -25 | 2 | 2 | 100 |
| 2nd quarter 2022 | 209 | 240 | -31 | 1 | 1 | 100 |
| 3rd quarter 2022 | 240 | 0 | ||||
| 4th quarter 2022 | 143 | 240 | -97 | 2 | 2 | 100 |
| 1st quarter 2023 | 289 | 240 | 49 | 1 | 0 | 0 |
| 2nd quarter 2023 | 391 | 240 | 151 | 5 | 1 | 20 |
| 3rd quarter 2023 | 422 | 240 | 182 | 1 | 0 | 0 |
Table 2. Total time for completed cases - Human medicines
| Total assessment times for closed cases - HUM | Average assessment time | Target days for full/abridged applications | Difference between assessment time and target days | No. of cases measured No. of drug Ids |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2022 | 229 | 240 | -11 | 2 | 2 | 100 |
| 2nd quarter 2022 | 215 | 240 | -25 | 2 | 2 |
100
|
| 3rd quarter 2022 | 209 | 240 | -31 | 1 | 1 | 100 |
| 4th quarter 2022 | 240 | 0 | ||||
| 1st quarter 2023 | 143 | 240 | -97 | 2 | 2 | 100 |
| 2nd quarter 2023 | 240 | 0 | ||||
| 3rd quarter 2023 | 431 | 240 | 191 | 4 | 0 | 0 |
| 4th quarter 2023 | 422 | 240 | 182 | 1 | 0 | 0 |
Table 3. Total time for completed cases - Veterinary medicines
| Total assessment times for closed cases - VET | Average assessment time | Target days for full/abridged applications | Difference between assessment time and target days | No. of cases measured No. of drug Ids |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2022 | 224 | 240 | -16 | 1 | 1 | 100 |
| 2nd quarter 2022 | 240 | 0 | ||||
| 3rd quarter 2022 | 240 | 0 | ||||
| 4th quarter 2022 | 240 | 0 | ||||
| 1st quarter 2023 | 240 | 0 | ||||
| 2nd quarter 2023 | 289 | 240 | 49 | 1 | 0 | 0 |
| 3rd quarter 2023 | 234 | 240 | -6 | 1 | 1 | 100 |
| 4th quarter 2023 | 240 | 0 |
Table 4. Start-up phase for completed cases
| Start-up phase for completed cases | Average assessment time | Target days | Difference between assessment time and target days | No. of cases measured No. of drug Ids |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2022 | 12 | 30 | -18 | 3 | 3 | 100 |
| 2nd quarter 2022 | 14 | 30 | -16 | 2 | 2 | 100 |
| 3rd quarter 2022 | 32 | 30 | 2 | 1 | 0 | 0 |
| 4th quarter 2022 | 30 | 0 | ||||
| 1st quarter 2023 | 3 | 30 | -27 | 2 | 2 | 100 |
| 2nd quarter 2023 | 1 | 30 | -29 | 1 | 1 | 100 |
| 3rd quarter 2023 | 25 | 30 | -5 | 5 | 2 | 40 |
| 4th quarter 2023 | 114 | 30 | 84 | 1 | 0 | 0 |
Table 5. Start-up phase for completed cases - Human medicines
| Start-up phase for completed cases - HUM | Average assessment time | Target days | Difference between assessment time and target days | No. of cases measured No. of drug Ids |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2022 | 7 | 30 | -23 | 2 | 2 | 100 |
| 2nd quarter 2022 | 14 | 30 | -16 | 2 | 2 | 100 |
| 3rd quarter 2022 | 32 | 30 | 2 | 1 | 0 | 0 |
| 4th quarter 2022 | 30 | 0 | ||||
| 1st quarter 2023 | 3 | 30 | -27 | 2 | 2 | 100 |
| 2nd quarter 2023 | 30 | 0 | ||||
| 3rd quarter 2023 | 24 | 30 | -6 | 4 | 1 | 25 |
| 4th quarter 2023 | 114 | 30 | 84 | 1 | 0 | 0 |
Table 6. Start-up phase for completed cases - Veterinary medicines
| Start-up phase for completed cases - VET | Average assessment time | Target days | Difference between assessment time and target days | No. of cases measured No. of drug Ids |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2022 | 21 | 30 | -9 | 1 | 1 | 100 |
| 2nd quarter 2022 | 30 | 0 | ||||
| 3rd quarter 2022 | 30 | 0 | ||||
| 4th quarter 2022 | 30 | 0 | ||||
| 1st quarter 2023 | 30 | 0 | ||||
| 2nd quarter 2023 | 1 | 30 | -29 | 1 | 1 | 100 |
| 3rd quarter 2023 | 27 | 30 | -3 | 1 | 1 | 100 |
| 4th quarter 2023 | 30 | 0 |
Table 7. Assessment time for remaining phases
| Total assessment times for assessment and closing phase | Average assessment time | Target days for full/abridged applications | Difference between assessment time and target days | No. of cases measured | No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2022 | 216 | 210 | 6 | 3 | 1 | 33 |
| 2nd quarter 2022 | 201 | 210 | -9 | 2 | 2 | 100 |
| 3rd quarter 2022 | 177 | 210 | -33 | 1 | 1 | 100 |
| 4th quarter 2022 | 210 | 0 | ||||
| 1st quarter 2023 | 140 | 210 | -70 | 2 | 2 | 100 |
| 2nd quarter 2023 | 288 | 210 | 78 | 1 | 0 | 0 |
| 3rd quarter 2023 | 367 | 210 | 157 | 5 | 1 | 20 |
| 4th quarter 2023 | 308 | 210 | 98 | 1 | 0 | 0 |
Table 8. Assessment time for remaining phases - Human medicines
| Total assessment times for assessment and closing phase - HUM | Average assessment time | Target days for full/abridged applications | Difference between assessment time and target days | No. of cases measured | No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2022 | 222 | 210 | 12 | 2 | 0 | 0 |
| 2nd quarter 2022 | 201 | 210 | -9 | 2 | 2 | 2 |
| 3rd quarter 2022 | 177 | 210 | -33 | 1 | 1 | 1 |
| 4th quarter 2022 | 210 | 0 | ||||
| 1st quarter 2023 | 140 | 210 | -70 | 2 | 2 | 100 |
| 2nd quarter 2023 | 210 | 0 | ||||
| 3rd quarter 2023 | 407 | 210 | 197 | 4 | 0 | 0 |
| 4th quarter 2023 | 308 | 210 | 98 | 1 | 0 | 0 |
Table 9. Assessment time for remaining phases - Veterinary medicines
| Total assessment times for assessment and closing phase - VET | Average assessment time | Target days for full/abridged applications | Difference between assessment time and target days | No. of cases measured | No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2022 | 203 | 210 | -7 | 1 | 1 | 100 |
| 2nd quarter 2022 | 210 | 0 | ||||
| 3rd quarter 2022 | 210 | 0 | ||||
| 4th quarter 2022 | 210 | 0 | ||||
| 1st quarter 2023 | 210 | 0 | ||||
| 2nd quarter 2023 | 288 | 210 | 78 | 1 | 0 | 0 |
| 3rd quarter 2023 | 207 | 210 | -3 | 1 | 1 | 100 |
| 4th quarter 2023 | 210 | 0 |
Table 10. Start-up phase for initiated procedures
| Start-up phase for initiated procedures | Average assessment time | Target days | Difference between assessment time and target days | No. of cases measured No. of drug Ids |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2022 | 30 | 0 | ||||
| 2nd quarter 2022 | 30 | 0 | ||||
| 3rd quarter 2022 | 28 | 30 | -2 | 8 | 6 | 75 |
| 4th quarter 2022 | 75 | 30 | 45 | 1 | 0 | 0 |
| 1st quarter 2023 | 32 | 30 | 2 | 1 | 0 | 0 |
| 2nd quarter 2023 | 30 | 0 | ||||
| 3rd quarter 2023 | 38 | 30 | 8 | 1 | 0 | 0 |
| 4th quarter 2023 | 25 | 30 | -5 | 1 | 1 | 100 |
Table 11. Start-up phase for initiated procedures - Human medicines
| Start-up phase for initiated procedures - HUM | Average assessment time | Target days | Difference between assessment time and target days | No. of cases measured No. of drug Ids |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2022 | 30 | 0 | ||||
| 2nd quarter 2022 | 30 | 0 | ||||
| 3rd quarter 2022 | 28 | 30 | -2 | 8 | 6 | 75 |
| 4th quarter 2022 | 75 | 30 | 45 | 1 | 0 | 0 |
| 1st quarter 2023 | 32 | 30 | 2 | 1 | 0 | 0 |
| 2nd quarter 2023 | 30 | 0 | ||||
| 3rd quarter 2023 | 38 | 30 | 8 | 1 | 0 | 0 |
| 4th quarter 2023 | 25 | 30 | -5 | 1 | 1 | 100 |
Table 12. Start-up phase for initiated procedures - Veterinary medicines
| Start-up phase for initiated procedures - VET | Average assessment time | Target days | Difference between assessment time and target days | No. of cases measured No. of drug Ids |
No. of cases within target | Share of cases within target in per cent |
| 1st quarter 2022 | 30 | 0 | ||||
| 2nd quarter 2022 | 30 | 0 | ||||
| 3rd quarter 2022 | 30 | 0 | ||||
| 4th quarter 2022 | 30 | 0 | ||||
| 1st quarter 2023 | 30 | 0 | ||||
| 2nd quarter 2023 | 30 | 0 | ||||
| 3rd quarter 2023 | 30 | 0 | ||||
| 4th quarter 2023 | 30 | 0 |