Tables on assessment times for new national applications

Updated 03 February 2016

Table 1. Total time for completed cases

Total assessment times for closed cases Average assessment time Target days for full/abridged applications Difference between assessment time and target days No. of cases measured
No. of drug IDs		 No. of cases within target Share of cases within targer in per cent 
1st quarter 2014 194 240 -46 4 4 100
2nd quarter 2014 215 240 -25 10 9 90
3rd quarter 2014 336 240 96 11 4 36
4th quarter 2014
 234 240 -6 5 3 60
1st quarter 2015
 162 240 -78 18 13 72
2nd quarter 2015
 197 240 -43 6 3 50
3rd quarter 2015 143  240  -97  8  7  88 
4th quarter 2015  337 240 97 4 0 0

Table 2. Total time for completed cases - Human medicines

Total assessment times for closed cases - HUM Average assessment time Target days for full/abridged applications Difference between assessment time and target days No. of cases measured
No. of drug IDs		 No. of cases within target Share of cases within targer in per cent 
1st quarter 2014 213 240 -27 2 2 100
2nd quarter 2014 216 240 -24 7 6 86
3rd quarter 2014 346 240 106 9 3 33
4th quarter 2014  234 240 -6 5 3 60
1st quarter 2015
 131 240 -109 13 10 77
2nd quarter 2015
 131 240 -109 1 1 100
3rd quarter 2015  124  240  -116  7  7  100 
4th quarter 2015  309 240 69 2 0 0

Table 3. Total time for completed cases - Veterinary medicines

Total assessment times for closed cases - VET Average assessment time Target days for full/abridged applications Difference between assessment time and target days No. of cases measured
No. of drug IDs		 No. of cases within target Share of cases within targer in per cent 
1st quarter 2014 222 240 -18 2 1 50
2nd quarter 2014 214 240 -26 3 3 100
3rd quarter 2014 293 240 53 2 1 50
4th quarter 2014
240   0    
1st quarter 2015
 243 240 3 5 3 60
2nd quarter 2015
 210 240 -30 5 2 40
3rd quarter 2015  272  240  32  1  0  0 
4th quarter 2015  365 240  125 2 0 0

Table 4. Start-up phase for completed cases

Start-up phase for completed cases Average assessment time Target days for full/abridged applications Difference between assessment time and target days No. of cases measured
No. of drug IDs		 No. of cases within target Share of cases within targer in per cent 
1st quarter 2014 13 30 -17 4 4 100
2nd quarter 2014 16 30 -14 10 9 90
3rd quarter 2014 30 30 0 11 4 36
4th quarter 2014
 23 30 -7 5 4 80
1st quarter 2015
 26 30 -4 18 10 56
2nd quarter 2015
 15 30 -15 6 5 83
3rd quarter 2015  20  30  -10  8  7  88 
4th quarter 2015  54 30 24 4 3 75

Table 5. Start-up phase for completed cases - Human medicines

Start-up phase for completed cases - HUM Average assessment time Target days for full/abridged applications Difference between assessment time and target days No. of cases measured
No. of drug IDs		 No. of cases within target Share of cases within targer in per cent 
1st quarter 2014 0 30 -30 2 2 100
2nd quarter 2014 22 30 -8 7 6 86
3rd quarter 2014 30 30 0 9 3 33
4th quarter 2014
 23 30 -7 5 4 80
1st quarter 2015
 29 30 -1 13 5 38
2nd quarter 2015
 4 30 -26 1 1 100
3rd quarter 2015  13  30  -17  7  7  100 
4th quarter 2015  19 30 -11 2 2 100

Table 6. Start-up phase for completed cases - Veterinary medicines

Start-up phase for completed cases - VET Average assessment time Target days for full/abridged applications Difference between assessment time and target days No. of cases measured
No. of drug IDs		 No. of cases within target Share of cases within targer in per cent 
1st quarter 2014 27 30 -3 2 2 100
2nd quarter 2014 1 30 -29 3 3 100
3rd quarter 2014 33 30 3 2 1 50
4th quarter 2014
   30   0    
1st quarter 2015
 17 30 -13 5 5 100
2nd quarter 2015
 17 30 -13 5 4 80
3rd quarter 2015  68  30  38  1  0  0 
4th quarter 2015  89 30 59 2 1 50

Table 7. Assessment time for remaining phases

Total assessment times for assessment and closing phase Average assessment time Target days for full/abridged applications Difference between assessment time and target days No. of cases measured
No. of drug IDs		 No. of cases within target Share of cases within targer in per cent 
1st quarter 2014 181 210 -29 4 2 50
2nd quarter 2014 200 210 -10 10 7 70
3rd quarter 2014 306 210 96 11 4 36
4th quarter 2014
 211 210 1 5 4 80
1st quarter 2015
 136 210 -74 18 13 72
2nd quarter 2015
 183 210 -27 6 4 67
3rd quarter 2015  123  210  -87  8  7  88 
4th quarter 2015  283  210 73 4 0 0

Table 8. Assessment time for remaining phases - Human medicines

Total assessment times for assessment and closing phases - HUM Average assessment time Target days for full/abridged applications Difference between assessment time and target days No. of cases measured
No. of drug IDs		 No. of cases within target Share of cases within targer in per cent 
1st quarter 2014 213 210 3 2 0 0
2nd quarter 2014 194 210 -16 7 6 86
3rd quarter 2014 316 210 106 9 3 33
4th quarter 2014
 211 210 1 5 4 80
1st quarter 2015
 101 210 -109 13 10 77
2nd quarter 2015
 127 210 -83 1 1 100
3rd quarter 2015  111  210  -99  7  6  86 
4th quarter 2015  290 210 80 2 0 0

Table 9. Assessment time for remaining phases - Veterinary medicines

Total assessment times for assessment and closing phases - VET Average assessment time Target days for full/abridged applications Difference between assessment time and target days No. of cases measured
No. of drug IDs		 No. of cases within target Share of cases within targer in per cent 
1st quarter 2014 149 210 -61 2 2 100
2nd quarter 2014 213 210 3 3 1 33
3rd quarter 2014 260 210 50 2 1 50
4th quarter 2014
   210   0    
1st quarter 2015
 226 210 16 5 3 60
2nd quarter 2015
 194 210 -16 5 3 60
3rd quarter 2015  204  210  -6  1  1  100 
4th quarter 2015  276 210 66 2 0 0

Table 10. Start-up phase for initiated procedures

Start-up phase for initiated procedures Average assessment time Target days for full/abridged applications Difference between assessment time and target days No. of cases measured
No. of drug IDs		 No. of cases within target Share of cases within targer in per cent 
1st quarter 2014 28 30 -2 3 2 67
2nd quarter 2014 11 30 -19 2 2 100
3rd quarter 2014 22 30 -8 24 22 92
4th quarter 2014
 22 30 -8 6 6 100
1st quarter 2015
 19 30 -11 17 9 53
2nd quarter 2015
 13 30 -17 9 9 100
3rd quarter 2015  19  30  -11  7  5  71 
4th quarter 2015  72 30 42 4 2 50

Table 11. Start-up phase for initiated procedures - Human medicines

Start-up phases for initiated procedures - HUM Average assessment time Target days for full/abridged applications Difference between assessment time and target days No. of cases measured
No. of drug IDs		 No. of cases within target Share of cases within targer in per cent 
1st quarter 2014 28 30 -2 3 2 67
2nd quarter 2014 11 30 -19 2 2 100
3rd quarter 2014 13 30 -17 20 20 100
4th quarter 2014
 20 30 -10 5 5 100
1st quarter 2015
 20 30 -10 16 8 50
2nd quarter 2015
 13 30 -17 9 9 100
3rd quarter 2015  3  30  -27  5  5  100 
4th quarter 2015  72 30 42 4 2 50

Table 12. Start-up phase for initiated procedures - Veterinary medicines

Start-up phase for initiated procedures - VET Average assessment time Target days for full/abridged applications Difference between assessment time and target days No. of cases measured
No. of drug IDs		 No. of cases within target Share of cases within targer in per cent 
1st quarter 2014   30   0    
2nd quarter 2014   30   0    
3rd quarter 2014 63 30 33 4 2 50
4th quarter 2014
 29 30 -1 1 1 100
1st quarter 2015
 0 30 -30 1 1 100
2nd quarter 2015
   30   0    
3rd quarter 2015  60  30  30  2  0  0 
4th quarter 2015    30