Tables on assessment times for national variations

Updated 02 February 2016

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 2014 31 30 1 1032 653 63
2nd quarter 2014 21 30 -9 1349 1080 80
3rd quarter 2014 33 30 3 673 422 63
4th quarter 2014
 26 30 -4 593 452 76
1st quarter 2015
 54 30 24 835 546 65
2nd quarter 2015
 30 30 0 950 782 82
3rd quarter 2015  33 30  3 805 615 76
4th quarter 2015  27 30 -3 739 634 86

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 2014 32 30 2 940 565 60
2nd quarter 2014 17 30 -13 1233 1033 84
3rd quarter 2014 34 30 4 644 394 61
4th quarter 2014
 26 30 -4 528 397 75
1st quarter 2015
 56 30 26 771 492 64
2nd quarter 2015
 32 30 2 796 632 79
3rd quarter 2015  36 30  6 683 498 73
4th quarter 2015  26 30 -4 690 602 87

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 2014 26 30 -4 92 88 96
2nd quarter 2014 60 30 30 116 47 41
3rd quarter 2014 20 30 -10 29 28 97
4th quarter 2014
 28 30 -2 65 55 85
1st quarter 2015
 28 30 -2 64 54 84
2nd quarter 2015
 19 30 -11 154 150 97
3rd quarter 2015  18  30  -12  122  117  96 
4th quarter 2015  31  30 1 49 32 65

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 2014 50 60 -10 852 684 80
2nd quarter 2014 62 60 2 758 538 71
3rd quarter 2014 56 60 -4 559 432 77
4th quarter 2014
 44 60 -16 567 478 84
1st quarter 2015
 48 60 -12 771 648 84
2nd quarter 2015
 44 60 -16 469 378 81
3rd quarter 2015  49 60  -11 546 481 88
4th quarter 2015  37 60 -23 656 570 87

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 2014 50 60 -10 778 636 82
2nd quarter 2014 64 60 4 640 443 69
3rd quarter 2014 75 60 15 497 387 78
4th quarter 2014
 45 60 -15 504 423 84
1st quarter 2015
 45 60 -15 711 601 85
2nd quarter 2015
 45 60 -15 436 346 79
3rd quarter 2015  51 60  -9  502 439 87
4th quarter 2015  37 60 -23 631 554 88

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 2014 51 60 -9 74 48 65
2nd quarter 2014 54 60 -6 118 96 81
3rd quarter 2014 41 60 -19 62 45 73
4th quarter 2014
 35 60 -25 63 55 87
1st quarter 2015
 74 60 14 60 47 78
2nd quarter 2015
 25 60 -35 33 32 97
3rd quarter 2015  25  60  -35  44  42  95 
4th quarter 2015  34 60 -26 25 16 64

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 2014 206 150 56 314 183 58
2nd quarter 2014 228 150 78 275 82 30
3rd quarter 2014 213 150 63 363 179 49
4th quarter 2014
 298 150 148 219 74 34
1st quarter 2015
 198 150 48 211 113 54
2nd quarter 2015
 243 150 93 206 94 46
3rd quarter 2015  153  150  3  219  133  61 
4th quarter 2015  105  150 -45 245 194 79

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 2014 204 150 54 295 181 61
2nd quarter 2014 218 150 68 242 76 31
3rd quarter 2014 196 150 46 335 178 53
4th quarter 2014
 298 150 148 211 71 34
1st quarter 2015
 202 150 52 198 102 52
2nd quarter 2015
 244 150 94 200 90 45
3rd quarter 2015  149  150  -1  209  128  61 
4th quarter 2015  97  150 -53 234 193 82

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 2014 246 150 96 19 2 11
2nd quarter 2014 295 150 145 33 6 18
3rd quarter 2014 424 150 274 28 1 4
4th quarter 2014
 302 150 152 8 3 38
1st quarter 2015
 140 150 -10 13 11 85
2nd quarter 2015
 196 150 46 6 4 67
3rd quarter 2015  229  150  79  10  5  50 
4th quarter 2015  282 150 132 11 1 9