Tables on assessment times for new national applications

Updated 16 June 2017

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 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
1st quarter 2016  243 240 3 7 5 71
2nd quarter 2016  225 240 -15 14 8 57
3rd quarter 2016  215 240 -25 8 8 100
4th quarter 2016  194 240 -46 6 6 100

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 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
1st quarter 2016  208 240 -32 5 4 80
2nd quarter 2016  234  240 -6 12 6 50
3rd quarter 2016  215 240 -25 8 8 100
4th quarter 2016  194 240 -46 6 6 100

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 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
1st quarter 2016  328  240 88 2 1 50
2nd quarter 2016  170 240 -70 2 2 100
3rd quarter 2016    240        
4th quarter 2016 
   240        

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 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
1st quarter 2016  17 30 -13 7 6 86
2nd quarter 2016  16 30 -14 14 12 86
3rd quarter 2016 
 3 30 -27 8 8 100
4th quarter 2016 
 6 30 -24 6 6 100

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 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
1st quarter 2016  18  30 -12 5 4 80
2nd quarter 2016  9  30 -21 12 12 100
3rd quarter 2016 
 3 30 -27 8 8 100
4th quarter 2016 
 6 30 -24 6 6 100

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 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
1st quarter 2016  17 30 -13 2 2 100
2nd quarter 2016  60 30 30 2 0 0
3rd quarter 2016 
30        
4th quarter 2016 
   30        

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 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
1st quarter 2016  225 210 15 7 4 57
2nd quarter 2016  209 210 -1 14 8 57
3rd quarter 2016  212 210 2 8 3 38
4th quarter 2016  188 210 -22 6 6 100

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 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
1st quarter 2016  191 210 -19 5 4 80
2nd quarter 2016  225 210 15 12 6 50
3rd quarter 2016 
 212 210 2 8 3 38
4th quarter 2016 
 188 210 -22 6 6 100

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 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
1st quarter 2016  312 210 102 2 0 0
2nd quarter 2016  110 210 -100 2 2 100
3rd quarter 2016 
210        
4th quarter 2016 
   210        

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 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
1st quarter 2016  30 30 0 15 10 67
2nd quarter 2016  11 30 -19 5 4 80
3rd quarter 2016 
 10 30 -20 1 1 100
4th quarter 2016  40 30 10 2 1 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 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
1st quarter 2016  23  30 -7 14 10 71
2nd quarter 2016  15 30 -15 3 2 67
3rd quarter 2016 
30        
4th quarter 2016  40 30 -10 2 1 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 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        
1st quarter 2016  127 30 97 1 0 0
2nd quarter 2016  5 30 -25 2 2 100
3rd quarter 2016  10 30 -20 1 1 100
4th quarter 2016    30