Tables on assessment times for new national applications

Updated 06 February 2019

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 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
1st quarter 2018    240    0     
2nd quarter 2018  218  240  -22  9  8  89 
3rd quarter 2018 237 240 -3 2 1 50
4th quarter 2018 211 240 -29 3 3 100

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 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
1st quarter 2018    240    0     
2nd quarter 2018  218  240  -22  9  8  89 
3rd quarter 2018
 237 240 -3 2 1 50
4th quarter 2018
 211 240 -29 3 3 100

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 2017   240   0     
2nd quarter 2017 269 240 29 2 1 50
3rd quarter 2017   240   0     
4th quarter 2017 193 240 -47 2 2 100
1st quarter 2018    240    0     
2nd quarter 2018    240    0     
3rd quarter 2018
240   0    
4th quarter 2018
   240   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 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
1st quarter 2018    30    0     
2nd quarter 2018  15  30  -15  9  8  89 
3rd quarter 2018
 87 30 57 2 1 50
4th quarter 2018
 2 30 -28 3 3 100

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 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
1st quarter 2018    30    0     
2nd quarter 2018  15  30  -15  9  8  89 
3rd quarter 2018
 87 30 57 2 1 50
4th quarter 2018
 2 30 -28 3 3 100

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 2017   30   0     
2nd quarter 2017 66 30 36 2 1 50
3rd quarter 2017   30   0    
4th quarter 2017 7 30 -23 2 2 100
1st quarter 2018    30    0     
2nd quarter 2018    30    0     
3rd quarter 2018
   30   0    
4th quarter 2018
   30   0    

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 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
1st quarter 2018    210    0     
2nd quarter 2018  202  210  -8  9  7  78 
3rd quarter 2018
 150 210 -60 2 2 100
4th quarter 2018
 209 210 -1 3 3 100

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 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
1st quarter 2018    210    0     
2nd quarter 2018  202  210  -8  9  7  78 
3rd quarter 2018
 150 210 -60 2 2 100
4th quarter 2018
 209 210 -1 3 3 100

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 2017   210   0     
2nd quarter 2017 203 210 -7 2 2 100
3rd quarter 2017   210   0     
4th quarter 2017 186 210 -24 2 2 100
1st quarter 2018    210    0     
2nd quarter 2018   210    0     
3rd quarter 2018
   210   0    
4th quarter 2018
   210   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 2017 4 30 -26 2 2 100
2nd quarter 2017 10 30 -20 5 5 100
3rd quarter 2017   30   0     
4th quarter 2017 1 30 -29 1 1 100
1st quarter 2018  2  30  -28  3  3  100 
2nd quarter 2018  6  30  -24  6  6  100 
3rd quarter 2018
 17 30 -13 6 5 83
4th quarter 2018
 30 30 0 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 2017 4 30 -26 2 2 100
2nd quarter 2017 10 30 -20 5 5 100
3rd quarter 2017   30   0     
4th quarter 2017 1 30 -29 1 1 100
1st quarter 2018  2  30  -28  3  3  100 
2nd quarter 2018  7  30  -23  5  5  100 
3rd quarter 2018
 17  30 -13 6 5 83
4th quarter 2018
 30 30 0 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 2017   30   0     
2nd quarter 2017
30   0     
3rd quarter 2017   30   0     
4th quarter 2017   30   0     
1st quarter 2018    30    0     
2nd quarter 2018  0  30  -30  1  1  100 
3rd quarter 2018
   30   0    
4th quarter 2018
   30   0