Tables on assessment times for new national applications
Updated 02 April 2014
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 2012 | 147 | 240 | -93 | 2 | 2 | 100 |
| 2nd quarter 2012 | 219 | 240 | -21 | 8 | 7 | 88 |
| 3rd quarter 2012 | 188 | 240 | -52 | 3 | 3 | 100 |
| 4th quarter 2012 | 199 | 40 | -41 | 4 | 3 | 75 |
| 1st quarter 2013 | 204 | 240 | -36 | 7 | 7 | 100 |
| 2nd quarter 2013 | 213 | 240 | -27 | 10 | 8 | 80 |
| 3rd quarter 2013 | 212 | 240 | -28 | 4 | 4 | 100 |
| 4th quarter 2013 | 200 | 240 | -40 | 9 | 9 | 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 2012 | 147 | 240 | -93 | 2 | 2 | 100 |
| 2nd quarter 2012 | 213 | 240 | -27 | 6 | 5 | 83 |
| 3rd quarter 2012 | 219 | 240 | -21 | 2 | 2 | 100 |
| 4th quarter 2012 | 199 | 240 | -41 | 4 | 3 | 75 |
| 1st quarter 2013 | 197 | 240 | -43 | 5 | 5 | 100 |
| 2nd quarter 2013 | 217 | 240 | -23 | 8 | 6 | 75 |
| 3rd quarter 2013 |
212 | 240 | -28 | 4 | 4 | 100 |
| 4th quarter 2013 | 221 | 240 | -19 | 3 | 3 | 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 2012 | 240 | 0 | ||||
| 2nd quarter 2012 | 235 | 240 | -5 | 2 | 2 | 100 |
| 3rd quarter 2012 | 126 | 240 | -114 | 1 | 1 | 100 |
| 4th quarter 2012 | 240 | -240 | 0 | |||
| 1st quarter 2013 | 220 | 240 | -20 | 2 | 2 | 100 |
| 2nd quarter 2013 | 198 | 240 | -42 | 2 | 2 | 100 |
| 3rd quarter 2013 |
240 | -240 | 0 | |||
| 4th quarter 2013 | 189 | 240 | -51 | 6 | 6 | 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 2012 | 39 | 30 | 9 | 2 | 0 | 0 |
| 2nd quarter 2012 | 36 | 30 | 6 | 8 | 2 | 25 |
| 3rd quarter 2012 | 17 | 30 | 13 | 3 | 3 | 100 |
| 4th quarter 2012 | 15 | 30 | -15 | 4 | 3 | 75 |
| 1st quarter 2013 | 21 | 30 | -9 | 7 | 4 | 57 |
| 2nd quarter 2013 | 21 | 30 | -9 | 10 | 9 | 90 |
| 3rd quarter 2013 |
13 | 30 | -17 | 4 | 4 | 100 |
| 4th quarter 2013 | 18 | 30 | -12 | 9 | 8 | 89 |
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 2012 | 39 | 30 | 9 | 2 | 0 | 0 |
| 2nd quarter 2012 | 34 | 30 | 4 | 6 | 2 | 33 |
| 3rd quarter 2012 | 19 | 30 | -11 | 2 | 2 | 100 |
| 4th quarter 2012 | 15 | 30 | -15 | 4 | 3 | 75 |
| 1st quarter 2013 | 21 | 30 | -9 | 5 | 3 | 60 |
| 2nd quarter 2013 | 11 | 30 | -19 | 8 | 8 | 100 |
| 3rd quarter 2013 |
13 | 30 | -17 | 4 | 4 | 100 |
| 4th quarter 2013 | 21 | 30 | -9 | 3 | 2 | 67 |
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 2012 | 30 | 0 | ||||
| 2nd quarter 2012 | 41 | 30 | 11 | 2 | 0 | 0 |
| 3rd quarter 2012 | 14 | 30 | -16 | 1 | 1 | 100 |
| 4th quarter 2012 | 30 | -30 | 0 | |||
| 1st quarter 2013 | 21 | 30 | -9 | 2 | 1 | 50 |
| 2nd quarter 2013 | 29 | 30 | -1 | 2 | 1 | 50 |
| 3rd quarter 2013 | 30 | -30 | 0 | |||
| 4th quarter 2013 | 16 | 30 | -14 | 6 | 6 | 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 2012 | 108 | 210 | -102 | 2 | 2 | 100 |
| 2nd quarter 2012 | 183 | 210 | -27 | 8 | 7 | 88 |
| 3rd quarter 2012 | 170 | 210 | -40 | 3 | 3 | 10 |
| 4th quarter 2012 | 184 | 210 | -26 | 4 | 4 | 100 |
| 1st quarter 2013 | 183 | 210 | -27 | 7 | 7 | 100 |
| 2nd quarter 2013 | 199 | 210 | -11 | 10 | 6 | 60 |
| 3rd quarter 2013 | 199 | 210 | -11 | 4 | 4 | 100 |
| 4th quarter 2013 | 182 | 210 | -28 | 9 | 7 | 78 |
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 2012 | 108 | 210 | -102 | 2 | 2 | 100 |
| 2nd quarter 2012 | 179 | 210 | -31 | 6 | 5 | 83 |
| 3rd quarter 2012 | 200 | 210 | -10 | 2 | 2 | 100 |
| 4th quarter 2012 | 184 | 210 | -26 | 4 | 4 | 100 |
| 1st quarter 2013 | 177 | 210 | -33 | 5 | 5 | 100 |
| 2nd quarter 2013 | 207 | 210 | -3 | 8 | 4 | 50 |
| 3rd quarter 2013 | 199 | 210 | -11 | 4 | 4 | 100 |
| 4th quarter 2013 | 199 | 210 | -11 | 3 | 3 | 100 |
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 2012 | 210 | 0 | ||||
| 2nd quarter 2012 | 194 | 210 | -16 | 2 | 2 | 100 |
| 3rd quarter 2012 | 112 | 210 | -98 | 1 | 1 | 100 |
| 4th quarter 2012 | 210 | -210 | 0 | |||
| 1st quarter 2013 | 200 | 210 | -10 | 2 | 2 | 100 |
| 2nd quarter 2013 | 169 | 210 | -41 | 2 | 2 | 100 |
| 3rd quarter 2013 | 210 | -210 | 0 | |||
| 4th quarter 2013 | 173 | 210 | -37 | 6 | 4 | 67 |
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 2012 | 16 | 30 | -14 | 7 | 7 | 100 |
| 2nd quarter 2012 | 13 | 30 | -17 | 9 | 7 | 78 |
| 3rd quarter 2012 | 2 | 30 | -28 | 2 | 2 | 100 |
| 4th quarter 2012 | 9 | 30 | -21 | 13 | 13 | 100 |
| 1st quarter 2013 | 23 | 30 | -7 | 4 | 4 | 100 |
| 2nd quarter 2013 | 26 | 30 | -4 | 5 | 3 | 60 |
| 3rd quarter 2013 | 20 | 30 | -10 | 7 | 6 | 86 |
| 4th quarter 2013 | 24 | 30 | -6 | 9 | 6 | 67 |
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 2012 | 19 | 30 | -11 | 5 | 5 | 100 |
| 2nd quarter 2012 | 7 | 30 | -23 | 5 | 5 | 100 |
| 3rd quarter 2012 | 2 | 30 | -28 | 2 | 2 | 100 |
| 4th quarter 2012 | 4 | 30 | -26 | 9 | 9 | 100 |
| 1st quarter 2013 | 30 | 30 | 0 | 3 | 3 | 100 |
| 2nd quarter 2013 | 37 | 30 | 7 | 2 | 1 | 50 |
| 3rd quarter 2013 | 10 | 30 | -20 | 3 | 3 | 100 |
| 4th quarter 2013 | 28 | 30 | -2 | 3 | 2 | 67 |
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 2012 | 10 | 30 | -20 | 2 | 2 | 100 |
| 2nd quarter 2012 | 20 | 30 | -10 | 4 | 2 | 50 |
| 3rd quarter 2012 | 30 | 0 | ||||
| 4th quarter 2012 | 22 | 30 | -8 | 4 | 4 | 100 |
| 1st quarter 2013 | 0 | 30 | -30 | 1 | 1 | 100 |
| 2nd quarter 2013 | 18 | 30 | -12 | 3 | 2 | 67 |
| 3rd quarter 2013 | 28 | 30 | -2 | 4 | 3 | 75 |
| 4th quarter 2013 | 22 | 30 | -8 | 6 | 4 | 67 |