Tables on assessment times for national variations 2020
Updated 17 March 2021
Table 1. Type 1A notifications
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 2019 | 12 | 30 | -18 | 530 | 521 | 98 |
2nd quarter 2019 | 11 | 30 | -19 | 455 | 449 | 99 |
3rd quarter 2019 |
6 | 30 | -24 | 3961 | 3929 | 99 |
4th quarter 2019 |
12 | 30 | -18 | 376 | 361 | 96 |
1st quarter 2020 |
66 | 30 | 36 | 335 | 275 | 82 |
2nd quarter 2020 |
15 | 30 | -15 | 640 | 509 | 80 |
3rd quarter 2020 |
12 | 30 | -18 | 338 | 332 | 98 |
4th quarter 2020 |
10 | 30 | -20 | 362 | 348 | 96 |
Table 2. 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 2019 |
12 | 30 | -18 | 441 | 433 | 98 |
2nd quarter 2019 |
10 | 30 | -20 | 389 | 383 | 98 |
3rd quarter 2019 |
6 | 30 | -24 | 3921 | 3889 | 99 |
4th quarter 2019 |
13 | 30 | -17 | 321 | 306 | 95 |
1st quarter 2020 |
70 | 30 | 40 | 313 | 253 | 81 |
2nd quarter 2020 |
15 | 30 | -15 | 618 | 488 | 79 |
3rd quarter 2020 |
12 | 30 | -18 | 324 | 318 | 98 |
4th quarter 2020 |
10 | 30 | -20 | 335 | 322 | 96 |
Table 3. Type 1A notifications - Veterinary 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 2019 |
12 | 30 | -18 | 89 | 88 | 99 |
2nd quarter 2019 |
14 | 30 | -16 | 66 | 66 | 100 |
3rd quarter 2019 |
16 | 30 | -14 | 40 | 40 | 100 |
4th quarter 2019 |
7 | 30 | -23 | 55 | 55 | 100 |
1st quarter 2020 | 8 | 30 | -22 | 22 | 22 | 100 |
2nd quarter 2020 |
10 | 30 | -20 | 22 | 21 | 95 |
3rd quarter 2020 |
8 | 30 | -22 | 14 | 14 | 100 |
4th quarter 2020 |
8 | 30 | -22 | 27 | 26 | 96 |
Table 4. Type IB notifications
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 2019 |
20 | 60 | -40 | 611 | 593 | 97 |
2nd quarter 2019 |
23 | 60 | -37 | 580 | 563 | 97 |
3rd quarter 2019 |
24 | 60 | -36 | 610 | 575 | 94 |
4th quarter 2019 |
30 | 60 | -30 | 575 | 534 | 93 |
1st quarter 2020 |
22 | 60 | -38 | 643 | 613 | 95 |
2nd quarter 2020 |
32 | 60 | -28 | 411 | 381 | 93 |
3rd quarter 2020 |
28 | 60 | -32 | 507 | 489 | 96 |
4th quarter 2020 |
23 | 60 | -37 | 541 | 489 | 90 |
Table 5. 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 2019 |
20 | 60 | -40 | 559 | 541 | 97 |
2nd quarter 2019 |
23 | 60 | -37 | 564 | 548 | 97 |
3rd quarter 2019 |
24 | 60 | -36 | 577 | 544 | 94 |
4th quarter 2019 |
31 | 60 | -29 | 512 | 471 | 92 |
1st quarter 2020 |
21 | 60 | -39 | 588 | 561 | 95 |
2nd quarter 2020 |
32 | 60 | -28 | 385 | 355 | 92 |
3rd quarter 2020 |
29 | 60 | -31 | 385 | 367 | 95 |
4th quarter 2020 |
22 | 60 | -38 | 508 | 458 | 90 |
Table 6. Type IB notifications - 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 2019 |
20 | 60 | -40 | 52 | 52 | 100 |
2nd quarter 2019 |
26 | 60 | -34 | 16 | 15 | 94 |
3rd quarter 2019 |
22 | 60 | -38 | 33 | 31 | 94 |
4th quarter 2019 |
23 | 60 | -37 | 63 | 63 | 100 |
1st quarter 2020 |
31 | 60 | -29 | 55 | 52 | 95 |
2nd quarter 2020 |
24 | 60 | -36 | 26 | 26 | 100 |
3rd quarter 2020 |
23 | 60 | -37 | 122 | 122 | 100 |
4th quarter 2020 |
29 | 60 | -31 | 33 | 31 | 94 |
Table 7. Type II notifications
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 2019 |
95 | 150 | -55 | 188 | 178 | 95 |
2nd quarter 2019 |
81 | 150 | -69 | 79 | 75 | 95 |
3rd quarter 2019 |
98 | 150 | -52 | 100 | 95 | 95 |
4th quarter 2019 |
86 | 150 | -64 | 101 | 86 | 85 |
1st quarter 2020 |
125 | 150 | -25 | 99 | 64 | 65 |
2nd quarter 2020 |
100 | 150 | -50 | 155 | 150 | 97 |
3rd quarter 2020 |
121 | 150 | -29 | 154 | 114 | 74 |
4th quarter 2020 |
93 | 150 | -57 | 104 | 80 | 77 |
Table 8. Type II notifications - Human 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 2019 |
90 | 150 | -60 | 160 | 156 | 98 |
2nd quarter 2019 |
84 | 150 | -66 | 71 | 67 | 94 |
3rd quarter 2019 |
99 | 150 | -51 | 97 | 92 | 95 |
4th quarter 2019 |
84 | 150 | -66 | 95 | 80 | 84 |
1st quarter 2020 |
130 | 150 | -20 | 95 | 60 | 63 |
2nd quarter 2020 |
103 | 150 | -47 | 146 | 141 | 97 |
3rd quarter 2020 |
113 | 150 | -37 | 147 | 112 | 76 |
4th quarter 2020 |
90 | 150 | -60 | 102 | 80 | 78 |
Table 9. Type II notifications - 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 2019 |
127 | 150 | -23 | 28 | 22 | 79 |
2nd quarter 2019 |
57 | 150 | -93 | 8 | 8 | 100 |
3rd quarter 2019 |
67 | 150 | -83 | 3 | 3 | 100 |
4th quarter 2019 |
116 | 150 | -34 | 6 | 6 | 100 |
1st quarter 2020 |
14 | 150 | -136 | 4 | 4 | 100 |
2nd quarter 2020 |
51 | 150 | -99 | 9 | 9 | 100 |
3rd quarter 2020 |
287 | 150 | 137 | 7 | 2 | 29 |
4th quarter 2020 |
286 | 150 | 136 | 2 | 0 | 0 |