Tables on assessment times for new national applications
19 July 2019,
Updated 05 March 2021
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 2018 | 240 | 0 | ||||
2nd quarter 2018 | 218 | 240 | -22 | 9 | 8 | 89 |
3rd quarter 2018 | 237 | 240 | -3 | 2 | 1 | 50 |
4th quarter 2018 | 211 | 240 | -29 | 3 | 3 | 100 |
1st quarter 2019 | 128 | 240 | -112 | 1 | 1 | 100 |
2nd quarter 2019 |
215 | 240 | -25 | 1 | 1 | 100 |
3rd quarter 2019 |
193 | 240 | -47 | 5 | 5 | 100 |
4th quarter 2019 |
184 | 240 | -56 | 5 | 5 | 100 |
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 2018 | 240 | 0 | ||||
2nd quarter 2018 | 218 | 240 | -22 | 9 | 8 | 89 |
3rd quarter 2018 |
237 | 240 | -3 | 2 | 1 | 50 |
4th quarter 2018 |
211 | 240 | -29 | 3 | 3 | 100 |
1st quarter 2019 | 128 | 240 | -112 | 1 | 1 | 100 |
2nd quarter 2019 |
215 | 240 | -25 | 1 | 1 | 100 |
3rd quarter 2019 |
193 | 240 | -47 | 5 | 5 | 100 |
4th quarter 2019 |
202 | 240 | -38 | 4 | 4 | 100 |
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 2018 | 240 | 0 | ||||
2nd quarter 2018 | 240 | 0 | ||||
3rd quarter 2018 |
240 | 0 | ||||
4th quarter 2018 |
240 | 0 | ||||
1st quarter 2019 |
240 | 0 | ||||
2nd quarter 2019 |
240 | 0 | ||||
3rd quarter 2019 |
240 | 0 | ||||
4th quarter 2019 |
111 | 240 | -29 | 1 | 1 | 100 |
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 2018 | 30 | 0 | ||||
2nd quarter 2018 | 15 | 30 | -15 | 9 | 8 | 89 |
3rd quarter 2018 |
87 | 30 | 57 | 2 | 1 | 50 |
4th quarter 2018 |
2 | 30 | -28 | 3 | 3 | 100 |
1st quarter 2019 |
27 | 30 | -3 | 1 | 1 | 100 |
2nd quarter 2019 |
10 | 30 | -20 | 1 | 1 | 100 |
3rd quarter 2019 |
7 | 30 | -23 | 5 | 5 | 100 |
4th quarter 2019 |
8 | 30 | -22 | 5 | 5 | 100 |
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 2018 | 30 | 0 | ||||
2nd quarter 2018 | 15 | 30 | -15 | 9 | 8 | 89 |
3rd quarter 2018 |
87 | 30 | 57 | 2 | 1 | 50 |
4th quarter 2018 |
2 | 30 | -28 | 3 | 3 | 100 |
1st quarter 2019 |
27 | 30 | -3 | 1 | 1 | 100 |
2nd quarter 2019 |
10 | 30 | -20 | 1 | 1 | 100 |
3rd quarter 2019 |
7 | 30 | -23 | 5 | 5 | 100 |
4th quarter 2019 |
9 | 30 | -21 | 4 | 4 | 100 |
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 2018 | 30 | 0 | ||||
2nd quarter 2018 | 30 | 0 | ||||
3rd quarter 2018 |
30 | 0 | ||||
4th quarter 2018 |
30 | 0 | ||||
1st quarter 2019 |
30 | 0 | ||||
2nd quarter 2019 |
30 | 0 | ||||
3rd quarter 2019 |
30 | 0 | ||||
4th quarter 2019 |
6 | 30 | -24 | 1 | 1 | 100 |
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 2018 | 210 | 0 | ||||
2nd quarter 2018 | 202 | 210 | -8 | 9 | 7 | 78 |
3rd quarter 2018 |
150 | 210 | -60 | 2 | 2 | 100 |
4th quarter 2018 |
209 | 210 | -1 | 3 | 3 | 100 |
1st quarter 2019 |
101 | 210 | -109 | 1 | 1 | 100 |
2nd quarter 2019 |
205 | 210 | -5 | 1 | 1 | 100 |
3rd quarter 2019 |
186 | 210 | -24 | 5 | 4 | 80 |
4th quarter 2019 |
175 | 210 | -35 | 5 | 4 | 80 |
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 2018 | 210 | 0 | ||||
2nd quarter 2018 | 202 | 210 | -8 | 9 | 7 | 78 |
3rd quarter 2018 |
150 | 210 | -60 | 2 | 2 | 100 |
4th quarter 2018 |
209 | 210 | -1 | 3 | 3 | 100 |
1st quarter 2019 |
101 | 210 | -109 | 1 | 1 | 100 |
2nd quarter 2019 |
205 | 210 | -5 | 1 | 1 | 100 |
3rd quarter 2019 |
186 | 210 | -24 | 5 | 4 | 80 |
4th quarter 2019 |
183 | 210 | -17 | 4 | 3 | 75 |
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 2018 | 210 | 0 | ||||
2nd quarter 2018 | 210 | 0 | ||||
3rd quarter 2018 |
210 | 0 | ||||
4th quarter 2018 |
210 | 0 | ||||
1st quarter 2019 |
210 | 0 | ||||
2nd quarter 2019 |
210 | 0 | ||||
3rd quarter 2019 |
210 | 0 | ||||
4th quarter 2019 |
105 | 210 | -105 | 1 | 1 | 100 |
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 2018 | 2 | 30 | -28 | 3 | 3 | 100 |
2nd quarter 2018 | 6 | 30 | -24 | 6 | 6 | 100 |
3rd quarter 2018 |
17 | 30 | -13 | 6 | 5 | 83 |
4th quarter 2018 |
30 | 30 | 0 | 1 | 1 | 100 |
1st quarter 2019 |
14 | 30 | -16 | 7 | 7 | 100 |
2nd quarter 2019 |
10 | 30 | -20 | 3 | 3 | 100 |
3rd quarter 2019 |
30 | 30 | 0 | 2 | 2 | 100 |
4th quarter 2019 |
6 | 30 | -24 | 4 | 4 | 100 |
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 2018 | 2 | 30 | -28 | 3 | 3 | 100 |
2nd quarter 2018 | 7 | 30 | -23 | 5 | 5 | 100 |
3rd quarter 2018 |
17 | 30 | -13 | 6 | 5 | 83 |
4th quarter 2018 |
30 | 30 | 0 | 1 | 1 | 100 |
1st quarter 2019 |
15 | 30 | -15 | 6 | 6 | 100 |
2nd quarter 2019 |
10 | 30 | -20 | 3 | 3 | 100 |
3rd quarter 2019 |
30 | 30 | 0 | 2 | 2 | 100 |
4th quarter 2019 |
6 | 30 | -24 | 4 | 4 | 100 |
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 2018 | 30 | 0 | ||||
2nd quarter 2018 | 0 | 30 | -30 | 1 | 1 | 100 |
3rd quarter 2018 |
30 | 0 | ||||
4th quarter 2018 |
30 | 0 | ||||
1st quarter 2019 |
6 | 30 | -24 | 1 | 1 | 100 |
2nd quarter 2019 |
30 | 0 | ||||
3rd quarter 2019 |
30 | 0 | ||||
4th quarter 2019 |
30 | 0 |