Tables on assessment times for national variations in 2021

Updated 16 February 2022

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 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
1st quarter 2021
 14 30 -16 498 435 87
2nd quarter 2021
 18 30 -12 405  377 93
3rd quarter 2021
 18 30  -12 406 373 92
4th quarter 2021
 28 30  -2 514 400 78

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 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
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

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 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
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

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 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
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

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 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
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

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 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
1st quarter 2021
 34 60  -26 39 33 85
2nd quarter 2021
 35 60  -25 50  45 90
3rd quarter 2021
 32 60  -28 43  36 84
4th quarter 2021
 24 60  -36 86 80 93

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 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
1st quarter 2021
 160 150  10 114 78 68
2nd quarter 2021
 171 150  21 112 56 50
3rd quarter 2021
 149 150 -1 130 69 53
4th quarter 2021
 191 150  41 72 43 60

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 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
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

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 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
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