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