Tables on assessment times for national variations

Updated 26 May 2015

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 2013 72 20 52 1190 180 15
2nd quarter 2013 62 20 42 944 180 19
3rd quarter 2013 27 20 7 1104 659 60
4th quarter 2013 29 20 9 633 418 66
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

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 2013 70 20 50 1085 155 14
2nd quarter 2013 62 20 42 885 161 18
3rd quarter 2013
 26 20 6 1022 611 60
4th quarter 2013 29 20 9 607 399 66
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

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 2013 91 20 71 105 25 24
2nd quarter 2013 67 20 47 59 19 32
3rd quarter 2013
 30 20 10 82 48 59
4th quarter 2013 37 20 17 26 19 73
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

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 2013 80 95 -15 422 288 68
2nd quarter 2013 106 95 11 343 209 61
3rd quarter 2013
 143 95 48 670 294 44
4th quarter 2013 103 95 8 640 395 62
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

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 2013 86 95 -9 375 245 65
2nd quarter 2013 108 95 13 316 191 60
3rd quarter 2013
 143 95 48 640 281 44
4th quarter 2013 105 95 10 569 349 61
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

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 2013 34 95 -61 47 43 91
2nd quarter 2013 80 95 -15 27 18 67
3rd quarter 2013 136 95 41 30 13 43
4th quarter 2013 93 95 -2 71 46 65
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

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 2013 119 185 -66 245 196 80
2nd quarter 2013 155 185 -30 277 189 68
3rd quarter 2013 253 185 68 425 107 25
4th quarter 2013 187 185 2 249 152 61
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

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 2013 115 185 -70 235 190 81
2nd quarter 2013 149 185 -36 256 180 70
3rd quarter 2013 254 185 69 409 102 25
4th quarter 2013 172 185 -13 229 151 66
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

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 2013 213 185 28 10 6 60
2nd quarter 2013 223 185 38 21 9 43
3rd quarter 2013 232 185 47 16 5 31
4th quarter 2013 358 185 173 20 1 5
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

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