Tables on assessment times for national variations

Table 1. Type IA notifications - Human medicines
Total assessment time for type IA variations - HUM Average assessment time Target days Difference between assessment time and target days No. of cases measured No. of cases within target Share of cases within target in per cent
No. of drug IDs
4th quarter 2022 84 30 54 536 230 43
1st quarter 2023 58 30 28 342 262 77
2nd quarter 2023 31 30 1 253 210 83
3rd quarter 2023 270 30 240 834 246 29
4th quarter 2023 34 30 4 234 188 80
1st quarter 2024 20 30 -10 947 928 98
2nd quarter 2024 15 30 -15 237 211 89
3rd quarter 2024 22 30 -8 415 393 95

 

Table 2. Type IA, VNRA notifications - Veterinary medicines
Total assessment time for type IA/VNRA variations - VET Average assessment time Target days Difference between assessment time and target days No. of cases measured No. of cases within target Share of cases within target in per cent
No. of drug IDs
4th quarter 2022 29 30 -1 21 16 76
1st quarter 2023 21 30 -9 92 89 97
2nd quarter 2023 21 30 -9 68 68 100
3rd quarter 2023 72 30 42 77 46 60
4th quarter 2023 33 30 3 72 62 86
1st quarter 2024 20 30 -10 66 53 80
2nd quarter 2024 11 30 -19 43 40 93
3rd quarter 2024 69 30 39 76 35 46

 

Table 3. Type IB variations - Human medicines
Total assessment time for type IB variations - HUM Average assessment time Target days Difference between assessment time and target days No. of cases measured No. of cases within target Share of cases within target in per cent
No. of drug IDs
4th quarter 2022 77 60 17 401 267 67
1st quarter 2023 60 60 0 486 347 71
2nd quarter 2023 54 60 -6 297 201 68
3rd quarter 2023 69 60 9 396 278 70
4th quarter 2023 59 60 -1 477 353 74
1st quarter 2024 40 60 -20 339 290 86
2nd quarter 2024 50 60 -10 421 341 81
3rd quarter 2024 60 60 0 255 226 89

 

Table 4. Type IB, VRA reduced variations - Veterinary medicines
Total assessment time for type IB/VRA reduced variations - VET Average assessment time Target days Difference between assessment time and target days No. of cases measured No. of cases within target Share of cases within target in per cent
No. of drug IDs
4th quarter 2022 19 60 -41 118 111 94
1st quarter 2023 28 60 -32 35 33 94
2nd quarter 2023 94 60 34 19 10 53
3rd quarter 2023 24 60 -36 9 8 89
4th quarter 2023 17 60 -43 12 11 92
1st quarter 2024 29 60 -31 17 15 88
2nd quarter 2024 24 60 -36 14 14 100
3rd quarter 2024 41 60 -19 4 3 75

 

Table 5. Type II variations - Human medicines
Total assessment time for type II variations - HUM Average assessment time Target days Difference between assessment time and target days No. of cases measured No. of cases within target Share of cases within target in per cent
No. of drug IDs
4th quarter 2022 180 150 30 79 40 51
1st quarter 2023 239 150 89 140 56 40
2nd quarter 2023 325 150 175 106 32 30
3rd quarter 2023 274 150 124 132 48 36
4th quarter 2023 285 150 135 206 53 26
1st quarter 2024 230 150 80 130 64 49
2nd quarter 2024 154 150 4 239 147 62
3rd quarter 2024 198 150 48 164 118 72

 

Table 6. Type II, VRA standard variations - Veterinary medicines
Total assessment time for type II/VRA standard variations - VET Average assessment time Target days Difference between assessment time and target days No. of cases measured No. of cases within target Share of cases within target in per cent
No. of drug IDs
4th quarter 2022 147 150 -3 4 3 75
1st quarter 2023 322 150 172 4 2 50
2nd quarter 2023 346 150 196 10 1 10
3rd quarter 2023 158 150 8 5 4 80
4th quarter 2023 201 150 51 7 2 29
1st quarter 2024 110 150 -40 6 5 83
2nd quarter 2024 159 150 9 9 5 56
3rd quarter 2024 156 150 6 12 8 67