Tables on assessment times for national variations in 2022
Updated 24 April 2023
Table 1. Type 1A notifications - Human medicines
| Total assessment time for type IA variations | Average assessment time | Target days | Difference between assessment times 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 2021 |
13 | 30 | -17 | 463 | 404 | 87 |
| 2nd quarter 2021 |
18 | 30 | -12 | 393 | 366 | 93 |
| 3rd quarter 2021 |
19 | 30 | -11 | 384 | 351 | 91 |
| 4th quarter 2021 |
30 | 30 | 0 | 481 | 367 | 76 |
| 1st quarter 2022 | 30 | 30 | 0 | 267 | 246 | 92 |
| 2nd quarter 2022 | 11 | 30 | -19 | 292 | 285 | 98 |
| 3rd quarter 2022 | 37 | 30 | 7 | 259 | 236 | 91 |
| 4th quarter 2022 | 84 | 30 | 54 | 536 | 230 | 43 |
Table 2. Type 1A notifications - Veterinary medicines
| Total assessment time for type IA/VNRA variations - VET |
Average assessment time | Target days | Difference between assessment times 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 2021 | 20 | 30 | -10 | 35 | 31 | 89 |
| 2nd quarter 2021 |
15 | 30 | -15 | 12 | 11 | 92 |
| 3rd quarter 2021 |
6 | 30 | -24 | 22 | 22 | 100 |
| 4th quarter 2021 |
10 | 30 | -20 | 33 | 33 | 100 |
| 1st quarter 2022 | 19 | 30 | -11 | 56 | 54 | 96 |
| 2nd quarter 2022 | 21 | 30 | -9 | 54 | 48 | 89 |
| 3rd quarter 2022 | 99 | 30 | 69 | 24 | 18 | 75 |
| 4th quarter 2022 | 29 | 30 | -1 | 21 | 16 | 76 |
Table 3. Type IB notifications - Human medicines
| Total assessment time for type IB variations | Average assessment time | Target days | Difference between assessment times 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 2021 |
31 | 60 | -29 | 390 | 356 | 91 |
| 2nd quarter 2021 |
38 | 60 | -22 | 379 | 318 | 84 |
| 3rd quarter 2021 |
37 | 60 | -23 | 539 | 437 | 81 |
| 4th quarter 2021 |
54 | 60 | -6 | 506 | 385 | 76 |
| 1st quarter 2022 | 85 | 60 | 25 | 288 | 164 | 57 |
| 2nd quarter 2022 | 36 | 60 | -24 | 360 | 323 | 90 |
| 3rd quarter 2022 | 68 | 60 | 8 | 315 | 224 | 71 |
| 4th quarter 2022 | 77 | 60 | 17 | 401 | 267 | 67 |
Table 4. Type IB variations - Veterinary medicines
| Total assessment time for type IB/VRA reduced variations - VET |
Average assessment time | Target days | Difference between assessment times 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 2021 |
31 | 60 | -29 | 351 | 323 | 92 |
| 2nd quarter 2021 |
39 | 60 | -21 | 329 | 273 | 83 |
| 3rd quarter 2021 |
38 | 60 | -22 | 496 | 401 | 81 |
| 4th quarter 2021 |
61 | 60 | 1 | 420 | 305 | 73 |
| 1st quarter 2022 | 77 | 60 | 17 | 47 | 28 | 60 |
| 2nd quarter 2022 | 82 | 60 | 22 | 46 | 28 | 61 |
| 3rd quarter 2022 | 84 | 60 | 24 | 17 | 11 | 65 |
| 4th quarter 2022 | 19 | 60 | -41 | 118 | 111 | 94 |
Table 5. Type II variations - Veterinary medicines
| Total assessment time for type IB variations | Average assessment time | Target days | Difference between assessment times 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 2021 |
160 | 150 | 10 | 106 | 74 | 70 |
| 2nd quarter 2021 |
180 | 150 | 30 | 103 | 47 | 46 |
| 3rd quarter 2021 |
146 | 150 | -4 | 127 | 69 | 54 |
| 4th quarter 2021 |
177 | 150 | 27 | 61 | 38 | 62 |
| 1st quarter 2022 | 192 | 150 | 42 | 31 | 8 | 26 |
| 2nd quarter 2022 | 167 | 150 | 17 | 84 | 53 | 63 |
| 3rd quarter 2022 | 199 | 150 | 49 | 80 | 42 | 53 |
| 4th quarter 2022 | 180 | 150 | 30 | 79 | 40 | 51 |
Table 6. Type II variations - Veterinary medicines
| Total assessment time for type II variations | Average assessment time | Target days | Difference between assessment times 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 2021 |
154 | 150 | 4 | 8 | 4 | 50 |
| 2nd quarter 2021 |
67 | 150 | -83 | 9 | 9 | 100 |
| 3rd quarter 2021 |
275 | 150 | 125 | 3 | 0 | 0 |
| 4th quarter 2021 |
270 | 150 | 120 | 11 | 5 | 45 |
| 1st quarter 2022 | 156 | 150 | 6 | 5 | 1 | 20 |
| 2nd quarter 2022 | 86 | 150 | -64 | 3 | 3 | 100 |
| 3rd quarter 2022 | 196 | 150 | 46 | 19 | 2 | 11 |
| 4th quarter 2022 | 147 | 150 | -3 | 4 | 3 | 75 |