Tables on assessment times for new national applications

Updated 13 February 2018

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 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
1st quarter 2017 255 240 15 5 3 60
2nd quarter 2017 234 240 -6 9 7 78
3rd quarter 2017 179 240 -61 2 2 100
4th quarter 2017 193 240 -47 8 7 88

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 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
1st quarter 2017 255 240 15 5 3 60
2nd quarter 2017 224 240 -16 7 6 86
3rd quarter 2017 179 240 -61 2 2 100
4th quarter 2017 192 240 -48 6 5 83

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 2016  328  240 88 2 1 50
2nd quarter 2016  170 240 -70 2 2 100
3rd quarter 2016    240        
4th quarter 2016 
   240        
1st quarter 2017   240        
2nd quarter 2017 269 240 29 2 1 50
3rd quarter 2017   240        
4th quarter 2017 193 240 -47 2 2 100

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 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
1st quarter 2017 37 30 7 5 4 80
2nd quarter 2017 33 30 3 9 6 67
3rd quarter 2017 19 30 -11 2 1 50
4th quarter 2017 15 30 -15 8 6 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 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
1st quarter 2017 37 30 7 5 4 80
2nd quarter 2017 23 30 -7 7 5 71
3rd quarter 2017 19 30 -11 2 1 50
4th quarter 2017 18 30 -12 6 4 67

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 2016  17 30 -13 2 2 100
2nd quarter 2016  60 30 30 2 0 0
3rd quarter 2016 
30        
4th quarter 2016 
   30      
1st quarter 2017   30        
2nd quarter 2017 66 30 36 2 1 50
3rd quarter 2017   30        
4th quarter 2017 7 30 -23 2 2 100

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 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
1st quarter 2017 219 210 9 5 4 80
2nd quarter 2017 201 210 -9 9 6 67
3rd quarter 2017 161 210 -49 2 2 100
4th quarter 2017 177 210 -33 8 7 88

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 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
1st quarter 2017 219 210 9 5 4 80
2nd quarter 2017 201 210 -9 7 4 57
3rd quarter 2017 161 210 -49 2 2 100
4th quarter 2017 175 210 -35 6 5 83

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 2016  312 210 102 2 0 0
2nd quarter 2016  110 210 -100 2 2 100
3rd quarter 2016 
210        
4th quarter 2016 
   210        
1st quarter 2017   210        
2nd quarter 2017 203 210 -7 2 2 100
3rd quarter 2017   210        
4th quarter 2017 186 210 -24 2 2 100

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 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
1st quarter 2017 4 30 -26 2 2 100
2nd quarter 2017 10 30 -20 5 5 100
3rd quarter 2017   30        
4th quarter 2017 1 30 -29 1 1 100

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 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
1st quarter 2017 4 30 -26 2 2 100
2nd quarter 2017 10 30 -20 5 5 100
3rd quarter 2017   30        
4th quarter 2017 1 30 -29 1 1 100

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 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        
1st quarter 2017   30        
2nd quarter 2017
30        
3rd quarter 2017   30        
4th quarter 2017   30