Tables on assessment times for new national applications

Updated 17 March 2021

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 2019 128 240 -112 1 1 100
2nd quarter 2019
 215 240 -25 1 1 100
3rd quarter 2019
 193 240 -47 5 5 100
4th quarter 2019
 184 240 -56 5 5 100
1st quarter 2020 193 240 -47 5 5 100
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

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 2019 128 240 -112 1 1 100
2nd quarter 2019
 215 240 -25 1 1 100
3rd quarter 2019
 193 240 -47 5 5 100
4th quarter 2019
 202 240 -38 4 4 100
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

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 2019
240   0    
2nd quarter 2019
   240   0    
3rd quarter 2019
240   0    
4th quarter 2019
 111 240 -29 1 1 100
1st quarter 2020 180 240 -60 1 1 100
2nd quarter 2020   240   0    
3rd quarter 2020   240   0    
4th quarter 2020   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 2019
 27 30 -3 1 1 100
2nd quarter 2019
 10 30 -20 1 1 100
3rd quarter 2019
 7 30 -23 5 5 100
4th quarter 2019
 8 30 -22 5 5 100
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

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 2019
 27 30 -3 1 1 100
2nd quarter 2019
 10 30 -20 1 1 100
3rd quarter 2019
 7 30 -23 5 5 100
4th quarter 2019
 9 30 -21 4 4 100
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

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 2019
   30   0    
2nd quarter 2019
   30   0    
3rd quarter 2019
   30   0    
4th quarter 2019
 6 30 -24 1 1 100
1st quarter 2020 0 30 -30 1 1 100
2nd quarter 2020   30   0    
3rd quarter 2020   30   0    
4th quarter 2020   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 2019
 101 210 -109 1 1 100
2nd quarter 2019
 205 210 -5 1 1 100
3rd quarter 2019
 186 210 -24 5 4 80
4th quarter 2019
 175 210 -35 5 4 80
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

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 2019
 101 210 -109 1 1 100
2nd quarter 2019
 205 210 -5 1 1 100
3rd quarter 2019
 186 210 -24 5 4 80
4th quarter 2019
 183 210 -17 4 3 75
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

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 2019
   210   0    
2nd quarter 2019
   210   0    
3rd quarter 2019
210   0    
4th quarter 2019
 105 210 -105 1 1 100
1st quarter 2020 180 210 -30 1 1 100
2nd quarter 2020   210   0    
3rd quarter 2020   210   0    
4th quarter 2020   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 2019
 14 30 -16 7 7 100
2nd quarter 2019
 10 30 -20 3 3 100
3rd quarter 2019
 30 30 0 2 2 100
4th quarter 2019
 6 30 -24 4 4 100
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

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 2019
 15 30 -15 6 6 100
2nd quarter 2019
 10 30 -20 3 3 100
3rd quarter 2019
 30 30 0 2 2 100
4th quarter 2019
 6 30 -24 4 4 100
1st quarter 2020
30   0    
2nd quarter 2020   30   0    
3rd quarter 2020 7 30 -23 2 2 100
4th quarter 2020   30   0    

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 2019
 6 30 -24 1 1 100
2nd quarter 2019
   30   0    
3rd quarter 2019
30   0    
4th quarter 2019
30
0    
1st quarter 2020   30   0    
2nd quarter 2020   30   0    
3rd quarter 2020   30   0    
4th quarter 2020 1 30 -29 1 1 100