Tables on assessment times for new national applications in 2022
Updated 21 April 2023
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 targer in per cent |
| 1st quarter 2021 | 223 | 240 | -17 | 7 | 7 | 100 |
| 2nd quarter 2021 | 240 | 0 | ||||
| 3rd quarter 2021 | 240 | 0 | ||||
| 4th quarter 2021 | 240 | 0 | ||||
| 1st quarter 2022 | 227 | 240 | -13 | 3 | 3 | 100 |
| 2nd quarter 2022 | 215 | 240 | -25 | 2 | 2 | 100 |
| 3rd quarter 2022 | 209 | 240 | -31 | 1 | 1 | 100 |
| 4th quarter 2022 | 240 | 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 targer in per cent |
| 1st quarter 2021 | 223 | 240 | -17 | 7 | 7 | 100 |
| 2nd quarter 2021 | 240 | 0 | ||||
| 3rd quarter 2021 | 240 | 0 | ||||
| 4th quarter 2021 | 240 | 0 | ||||
| 1st quarter 2022 | 22 | 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 |
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 targer in per cent |
| 1st quarter 2021 | 240 | 0 | ||||
| 2nd quarter 2021 | 240 | 0 | ||||
| 3rd quarter 2021 | 240 | 0 | ||||
| 4th quarter 2021 | 240 | 0 | ||||
| 1st quarter 2022 | 224 | 240 | -16 | 1 | 1 | 100 |
| 2nd quarter 2022 | 240 | 0 | ||||
| 3rd quarter 2022 | 240 | 0 | ||||
| 4th quarter 2022 | 240 | 0 |
Table 4. Start-up phase for completed cases
| Start-up phase for completed 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 targer in per cent |
| 1st quarter 2021 | 16 | 30 | -14 | 7 | 7 | 100 |
| 2nd quarter 2021 | 30 | 0 | ||||
| 3rd quarter 2021 | 30 | 0 | ||||
| 4th quarter 2021 | 30 | 0 | ||||
| 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 |
Table 5. Start-up phase for completed cases - Human medicines
| Start-up phase for completed 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 targer in per cent |
| 1st quarter 2021 | 16 | 30 | -14 | 7 | 7 | 100 |
| 2nd quarter 2021 | 30 | 0 | ||||
| 3rd quarter 2021 | 30 | 0 | ||||
| 4th quarter 2021 | 30 | 0 | ||||
| 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 |
Table 6. Start-up phase for completed cases - Veterinary medicines
| Start-up phase for completed 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 targer in per cent |
| 1st quarter 2021 | 30 | 0 | ||||
| 2nd quarter 2021 | 30 | 0 | ||||
| 3rd quarter 2021 | 30 | 0 | ||||
| 4th quarter 2021 | 30 | 0 | ||||
| 1st quarter 2022 | 21 | 30 | -9 | 1 | 1 | 100 |
| 2nd quarter 2022 | 30 | 0 | ||||
| 3rd quarter 2022 | 30 | 0 | ||||
| 4th quarter 2022 | 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 drug IDs |
No. of cases within target | Share of cases within targer in per cent |
| 1st quarter 2021 | 207 | 210 | -3 | 7 | 7 | 100 |
| 2nd quarter 2021 | 210 | 0 | ||||
| 3rd quarter 2021 | 210 | 0 | ||||
| 4th quarter 2021 | 210 | 0 | ||||
| 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 |
Table 8. Assessment time for remaining phases - Human medicines
| Total assessment times for assessment and closing phases - 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 targer in per cent |
| 1st quarter 2021 | 207 | 210 | -3 | 7 | 7 | 100 |
| 2nd quarter 2021 | 210 | 0 | ||||
| 3rd quarter 2021 | 210 | 0 | ||||
| 4th quarter 2021 | 210 | 0 | ||||
| 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 |
Table 9. Assessment time for remaining phases - Veterinary medicines
| Total assessment times for assessment and closing phases - 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 targer in per cent |
| 1st quarter 2021 | 210 | 0 | ||||
| 2nd quarter 2021 | 210 | 0 | ||||
| 3rd quarter 2021 | 210 | 0 | ||||
| 4th quarter 2021 | 210 | 0 | ||||
| 1st quarter 2022 | 203 | 210 | -7 | 1 | 1 | 100 |
| 2nd quarter 2022 | 210 | 0 | ||||
| 3rd quarter 2022 | 210 | 0 | ||||
| 4th quarter 2022 | 210 | 0 |
Table 10. Start-up phase for initiated procedures
| Start-up phase for initiated procedures | 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 targer in per cent |
| 1st quarter 2021 | 19 | 30 | -11 | 5 | 4 | 80 |
| 2nd quarter 2021 | 27 | 30 | -3 | 1 | 1 | 100 |
| 3rd quarter 2021 | 31 | 30 | 1 | 4 | 0 | 0 |
| 4th quarter 2021 | 4 | 30 | -26 | 5 | 5 | 100 |
| 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 |
Table 11. Start-up phase for initiated procedures - Human medicines
| Start-up phases for initiated procedures - 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 targer in per cent |
| 1st quarter 2021 | 24 | 30 | -6 | 4 | 3 | 75 |
| 2nd quarter 2021 | 30 | 0 | ||||
| 3rd quarter 2021 | 31 | 30 | 1 | 4 | 0 | 0 |
| 4th quarter 2021 | 4 | 30 | -26 | 5 | 5 | 100 |
| 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 |
Table 12. Start-up phase for initiated procedures - Veterinary medicines
| Start-up phase for initiated procedures - 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 targer in per cent |
| 1st quarter 2021 | 1 | 30 | -29 | 1 | 1 | 100 |
| 2nd quarter 2021 | 27 | 30 | -3 | 1 | 1 | 100 |
| 3rd quarter 2021 | 30 | 0 | ||||
| 4th quarter 2021 | 30 | 0 | ||||
| 1st quarter 2022 | 30 | 0 | ||||
| 2nd quarter 2022 | 30 | 0 | ||||
| 3rd quarter 2022 | 30 | 0 | ||||
| 4th quarter 2022 | 30 | 0 |