Tables on assessment times for new national applications in 2021

Updated 16 February 2022

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 2020 193 240  -47  5  5  100 
2nd quarter 2020
 172 240  -58  2  2  100 
3rd quarter 2020
 239 240  -1  1  1  100 
4th quarter 2020
 210 240  -30  3  3  100 
1st quarter 2021 223 240  -17  7  7  100 
2nd quarter 2021   240    0     
3rd quarter 2021   240    0     
4th quarter 2021   240    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 2020 196 240  -44  4  4  100 
2nd quarter 2020
 172 240  -68  2  2  100 
3rd quarter 2020
 239 240  -1  1  1  100
4th quarter 2020
 210 240 -30  3  3  100 
1st quarter 2021 223 240  -17  7  7  100
2nd quarter 2021   240    0     
3rd quarter 2021   240    0     
4th quarter 2021
240    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 2020
 180 240  -60  1  1  100 
2nd quarter 2020
   240   0     
3rd quarter 2020
   240    0     
4th quarter 2020
   240    0     
1st quarter 2021   240    0     
2nd quarter 2021   240
0     
3rd quarter 2021   240   0     
4th quarter 2021   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 2020
 18 30  -12  5  5  100 
2nd quarter 2020
 14 30  -16  2  2  100 
3rd quarter 2020
 35 30  5  1  0  0 
4th quarter 2020
 2 30  -28  3  3  100 
1st quarter 2021 16 30  -14  7  7  100 
2nd quarter 2021   30    0     
3rd quarter 2021   30    0     
4th quarter 2021   30    0    

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 2020
 22 30  -8  4  4  100 
2nd quarter 2020
 14 30  -16  2  2  100
3rd quarter 2020
 35 30  5  1  0  0 
4th quarter 2020
 2 30  -28  3  3  100
1st quarter 2021 16 30  -14  7  7  100
2nd quarter 2021   30    0     
3rd quarter 2021   30    0     
4th quarter 2021   30   0     

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 2020
 0  30 -30  1  1  100 
2nd quarter 2020
   30   0     
3rd quarter 2020
   30   0     
4th quarter 2020
   30    0     
1st quarter 2021   30    0     
2nd quarter 2021   30   0     
3rd quarter 2021   30   0     
4th quarter 2021   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 2020
 175 210  -35  5  5  100 
2nd quarter 2020 159  210  -51  2  2  100 
3rd quarter 2020
 204 210  -6  1  1  100 
4th quarter 2020
 207 210  -3  3  1  33 
1st quarter 2021 207 210  -3  7  7  100 
2nd quarter 2021   210    0     
3rd quarter 2021   210    0     
4th quarter 2021   210    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 2020
 174 210  -36  4  4  100 
2nd quarter 2020
 159 210  -51  2  2  100
3rd quarter 2020
 204 210  -6  1  1  100 
4th quarter 2020
 207 210  -3  3  1  33 
1st quarter 2021 207 210 -3  7  7  100
2nd quarter 2021   210    0     
3rd quarter 2021   210    0     
4th quarter 2021   210    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 2020
 180  210 -30  1  1  100 
2nd quarter 2020
   210   0     
3rd quarter 2020
   210    0     
4th quarter 2020
   210    0     
1st quarter 2021   210    0    
2nd quarter 2021   210   0     
3rd quarter 2021   210   0     
4th quarter 2021   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 2020
   30    0     
2nd quarter 2020
   30    0     
3rd quarter 2020
 7 30  -23  2  2  100 
4th quarter 2020
 1 30  -29  1  1  100 
1st quarter 2021 19 30  -11  5  4  80 
2nd quarter 2021 27  30 -3  1  1  100 
3rd quarter 2021 31 30  1  4  0  0 
4th quarter 2021 4 30  -26  5  5  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 2020
   30    0     
2nd quarter 2020
   30    0     
3rd quarter 2020
 7 30  -23  2  2  100 
4th quarter 2020
   30    0     
1st quarter 2021 24 30 -6  4  3  75 
2nd quarter 2021   30   0     
3rd quarter 2021 31 30  1  4  0  0 
4th quarter 2021 4  30 -26  5  5  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 2020
   30    0     
2nd quarter 2020
   30   0     
3rd quarter 2020
   30    0     
4th quarter 2020
 1 30  -29  1  1  100 
1st quarter 2021 1 30 -29  1  1 100 
2nd quarter 2021 27  30 -3  1  1 100 
3rd quarter 2021   30   0     
4th quarter 2021   30    0