Assessment times for new national applications for the licensing of medicinal products - 2025
The assessment times are divided respectively in human and veterinary medicines. The assessment time of new national applications for the licensing of medicinal products, are calculated in the following way:
- Total assessment time
- Assessment time of the start-up phase.
- Assessment time of remaining phases
- Assessment times of these cases
For Q3 2025, we make the following observations:
In 2025, we have completed 2 cases, of which 0 cases (0 %) were completed within the performance requirement of 240 days. In 2024, 55 % of all cases where finished within the performance requirement. Due to the Covid-19 pandemic, the Danish Medicines Agency did not prioritize the assessments times. The changed prioritization takes effect in the assessment times and will therefore affect compliance until the cases are completed. In is expected that the cases completed in 2026 will finish within the performance requirement.
While focusing on the total assessment time, we make every effort to meet the maximum time allowed in the start-up phase, and Chart 2 below shows the assessment time for cases with a completed start-up phase (i.e. the assessment time is measured from the close of the start-up phase).
Total assessment times for completed cases
Status for 2025 as at end-December 2025: 5 cases for medicine have been completed, 4 cases for human medicines and 1 case for veterinary medicines.
Total for human medicines
- 50 % of the cases finished within the performance requirement's maximum of 240 days (283 days on average).
- 50 % of the cases finished within the performance requirement's maximum of 30 days in the start-up phase (34 days on average).
- 25 % of the cases finished within the performance requirement's maximum of 210 days in the assessment and closing phases (249 days on average).
Total for veterinary medicines
- 100 % of the cases finished within the performance requirement's maximum of 240 days (239 days on average).
- 0 % of the cases finished within the performance requirement's maximum of 30 days in the start-up phase (67 days on average).
100 % of the cases finished within the performance requirement's maximum of 210 days in the assessment and closing phases (172 days on average).
Chart 1. Assessment times for completed cases
There were no completed cases in Q1 2024, Q1 2025 and Q3 2025
See table 1-9 for completed cases
|
Table 1. Total time 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 cases within target |
Share of cases within target in per cent |
|
Total assessment times for closed cases |
No. of drug IDs |
|||||
|
1st quarter 2024 |
|
240 |
|
0 |
|
|
|
2nd quarter 2024 |
266 |
240 |
26 |
4 |
3 |
75 |
|
3rd quarter 2024 |
280 |
240 |
40 |
7 |
1 |
14 |
|
4th quarter 2024 |
265 |
240 |
25 |
9 |
7 |
78 |
|
1st quarter 2025 |
|
240 |
|
0 |
|
|
|
2nd quarter 2025 |
353 |
240 |
113 |
2 |
0 |
0 |
|
3rd quarter 2025 |
|
240 |
|
0 |
|
|
|
4th quarter 2025 |
221 |
240 |
-19 |
3 |
3 |
100 |
|
Table 2. Total time for completed cases - Human medicines |
||||||
|
|
Average assessment time |
Target days for full/abridged applications |
Difference between assessment time and target days |
No. of cases measured |
No. of cases within target |
Share of cases within target in per cent |
|
Total assessment times for closed cases - HUM |
No. of drug IDs |
|||||
|
1st quarter 2024 |
|
240 |
|
0 |
|
|
|
2nd quarter 2024 |
266 |
240 |
26 |
4 |
3 |
75 |
|
3rd quarter 2024 |
280 |
240 |
40 |
7 |
1 |
14 |
|
4th quarter 2024 |
265 |
240 |
25 |
9 |
7 |
78 |
|
1st quarter 2025 |
|
240 |
|
0 |
|
|
|
2nd quarter 2025 |
353 |
240 |
113 |
2 |
0 |
0 |
|
3rd quarter 2025 |
|
240 |
|
0 |
|
|
|
4th quarter 2025 |
213 |
240 |
-27 |
2 |
2 |
100 |
|
Table 3. Total time for completed cases - Veterinary medicines |
||||||
|
|
Average assessment time |
Target days for full/abridged applications |
Difference between assessment time and target days |
No. of cases measured |
No. of cases within target |
Share of cases within target in per cent |
|
Total assessment times for closed cases - VET |
No. of drug IDs |
|||||
|
1st quarter 2024 |
|
240 |
|
0 |
|
|
|
2nd quarter 2024 |
|
240 |
|
0 |
|
|
|
3rd quarter 2024 |
|
240 |
|
0 |
|
|
|
4th quarter 2024 |
|
240 |
|
0 |
|
|
|
1st quarter 2025 |
|
240 |
|
0 |
|
|
|
2nd quarter 2025 |
|
240 |
|
0 |
|
|
|
3rd quarter 2025 |
|
240 |
|
0 |
|
|
|
4th quarter 2025 |
239 |
240 |
-1 |
1 |
1 |
100 |
|
Table 4. Start-up phase for completed cases |
||||||
|
|
Average assessment time |
Target days |
Difference between assessment time and target days |
No. of cases measured |
No. of cases within target |
Share of cases within target in per cent |
|
Start-up phase for completed cases |
No. of drug IDs |
|||||
|
1st quarter 2024 |
|
30 |
|
0 |
|
|
|
2nd quarter 2024 |
32 |
30 |
2 |
4 |
3 |
75 |
|
3rd quarter 2024 |
11 |
30 |
-19 |
7 |
7 |
100 |
|
4th quarter 2024 |
24 |
30 |
-6 |
9 |
6 |
67 |
|
1st quarter 2025 |
|
30 |
|
0 |
|
|
|
2nd quarter 2025 |
57 |
30 |
27 |
2 |
0 |
0 |
|
3rd quarter 2025 |
|
30 |
|
0 |
|
|
|
4th quarter 2025 |
29 |
30 |
-1 |
3 |
3 |
100 |
|
Table 5. Start-up phase for completed cases - Human medicines |
||||||
|
|
Average assessment time |
Target days |
Difference between assessment time and target days |
No. of cases measured |
No. of cases within target |
Share of cases within target in per cent |
|
Start-up phase for completed cases - HUM |
No. of drug IDs |
|||||
|
1st quarter 2024 |
|
30 |
|
0 |
|
|
|
2nd quarter 2024 |
32 |
30 |
2 |
4 |
3 |
75 |
|
3rd quarter 2024 |
11 |
30 |
-19 |
7 |
7 |
100 |
|
4th quarter 2024 |
24 |
30 |
-6 |
9 |
6 |
67 |
|
1st quarter 2025 |
|
30 |
|
0 |
|
|
|
2nd quarter 2025 |
57 |
30 |
27 |
2 |
0 |
0 |
|
3rd quarter 2025 |
|
30 |
|
0 |
|
|
|
4th quarter 2025 |
11 |
30 |
-19 |
2 |
2 |
100 |
|
Table 6. Start-up phase for completed cases - Veterinary medicines |
||||||
|
|
Average assessment time |
Target days |
Difference between assessment time and target days |
No. of cases measured |
No. of cases within target |
Share of cases within target in per cent |
|
Start-up phase for completed cases - VET |
No. of drug IDs |
|||||
|
1st quarter 2024 |
|
30 |
|
0 |
|
|
|
2nd quarter 2024 |
|
30 |
|
0 |
|
|
|
3rd quarter 2024 |
|
30 |
|
0 |
|
|
|
4th quarter 2024 |
|
30 |
|
0 |
|
|
|
1st quarter 2025 |
|
30 |
|
0 |
|
|
|
2nd quarter 2025 |
|
30 |
|
0 |
|
|
|
3rd quarter 2025 |
|
30 |
|
0 |
|
|
|
4th quarter 2025 |
67 |
30 |
37 |
1 |
0 |
0 |
|
Table 7. Assessment time for remaining phases |
||||||
|
|
Average assessment time |
Target days for full/abridged applications |
Difference between assessment time and target days |
No. of cases measured |
No. of cases within target |
Share of cases within target in per cent |
|
Total assessment times for assessment and closing phase |
No. of drug IDs |
|||||
|
1st quarter 2024 |
|
210 |
|
0 |
|
|
|
2nd quarter 2024 |
234 |
210 |
24 |
4 |
3 |
75 |
|
3rd quarter 2024 |
269 |
210 |
59 |
7 |
1 |
14 |
|
4th quarter 2024 |
242 |
210 |
32 |
9 |
1 |
11 |
|
1st quarter 2025 |
|
210 |
|
0 |
|
|
|
2nd quarter 2025 |
296 |
210 |
86 |
2 |
0 |
0 |
|
3rd quarter 2025 |
|
210 |
|
0 |
|
|
|
4th quarter 2025 |
192 |
210 |
-18 |
3 |
3 |
100 |
|
Table 8. Assessment time for remaining phases - Human medicines |
||||||
|
|
Average assessment time |
Target days for full/abridged applications |
Difference between assessment time and target days |
No. of cases measured |
No. of cases within target |
Share of cases within target in per cent |
|
Total assessment times for assessment and closing phase - HUM |
No. of drug IDs |
|||||
|
1st quarter 2024 |
|
210 |
|
0 |
|
|
|
2nd quarter 2024 |
234 |
210 |
24 |
4 |
3 |
75 |
|
3rd quarter 2024 |
269 |
210 |
59 |
7 |
1 |
14 |
|
4th quarter 2024 |
242 |
210 |
32 |
9 |
1 |
11 |
|
1st quarter 2025 |
|
210 |
|
0 |
|
|
|
2nd quarter 2025 |
296 |
210 |
86 |
2 |
0 |
0 |
|
3rd quarter 2025 |
|
210 |
|
0 |
|
|
|
4th quarter 2025 |
202 |
210 |
-8 |
2 |
2 |
100 |
|
Table 9. Assessment time for remaining phases - Veterinary medicines |
||||||
|
|
Average assessment time |
Target days for full/abridged applications |
Difference between assessment time and target days |
No. of cases measured |
No. of cases within target |
Share of cases within target in per cent |
|
Total assessment times for assessment and closing phase - VET |
No. of drug IDs |
|||||
|
1st quarter 2024 |
|
210 |
|
0 |
|
|
|
2nd quarter 2024 |
|
210 |
|
0 |
|
|
|
3rd quarter 2024 |
|
210 |
|
0 |
|
|
|
4th quarter 2024 |
|
210 |
|
0 |
|
|
|
1st quarter 2025 |
|
210 |
|
0 |
|
|
|
2nd quarter 2025 |
|
210 |
|
0 |
|
|
|
3rd quarter 2025 |
|
210 |
|
0 |
|
|
|
4th quarter 2025 |
172 |
210 |
-38 |
1 |
1 |
100 |
The total assessment time is measured against the target time of 240 days for 2025 from the date on which we receive the application until the date of determination (grant or refusal), excluding any clock-stop days.
The assessment time in the start-up phase is measured against the target time of 30 days for 2025 from the date when we receive the application until the procedure start date (day 0).
The assessment time for the remaining phases is measured against the target time of 210 days for 2025 from the procedure start date (day 0) until the date of determination (grant or refusal), excluding any clock-stop days.
Assessment times for initiated cases
Status for 2025 as at end-December 2025: 13 cases for medicine have completed the start-up phase, 12 cases for human medicines and 1 case for veterinary medicines.
- Total for human and veterinary medicines: 100 % of the cases finished within the performance requirement's maximum of 30 days (9 days on average).
- Human medicines: 100 % of the cases finished within the performance requirement's maximum of 30 days (8 days on average).
- Veterinary medicines: 100 % of the cases finished within the performance requirement's maximum of 30 days (23 days on average).
Chart 2. Assessment times for initiated procedures
|
Table 10. Start-up phase for initiated procedures |
||||||
|
|
Average assessment time |
Target days |
Difference between assessment time and target days |
No. of cases measured |
No. of cases within target |
Share of cases within target in per cent |
|
Start-up phase for initiated procedures |
No. of drug IDs |
|||||
|
1st quarter 2024 |
6 |
30 |
-24 |
1 |
1 |
100 |
|
2nd quarter 2024 |
49 |
30 |
19 |
1 |
0 |
0 |
|
3rd quarter 2024 |
56 |
30 |
26 |
4 |
1 |
25 |
|
4th quarter 2024 |
21 |
30 |
-9 |
2 |
2 |
100 |
|
1st quarter 2025 |
28 |
30 |
-2 |
1 |
1 |
100 |
|
2nd quarter 2025 |
8 |
30 |
-22 |
1 |
1 |
100 |
|
3rd quarter 2025 |
7 |
30 |
-23 |
4 |
4 |
100 |
|
4th quarter 2025 |
8 |
30 |
-22 |
7 |
7 |
100 |
|
Table 11. Start-up phase for initiated procedures - Human medicines |
||||||
|
|
Average assessment time |
Target days |
Difference between assessment time and target days |
No. of cases measured |
No. of cases within target |
Share of cases within target in per cent |
|
Start-up phase for initiated procedures - HUM |
No. of drug IDs |
|||||
|
1st quarter 2024 |
6 |
30 |
-24 |
1 |
1 |
100 |
|
2nd quarter 2024 |
49 |
30 |
19 |
1 |
0 |
0 |
|
3rd quarter 2024 |
53 |
30 |
23 |
3 |
1 |
33 |
|
4th quarter 2024 |
21 |
30 |
-9 |
2 |
2 |
100 |
|
1st quarter 2025 |
28 |
30 |
-2 |
1 |
1 |
100 |
|
2nd quarter 2025 |
8 |
30 |
-22 |
1 |
1 |
100 |
|
3rd quarter 2025 |
2 |
30 |
-28 |
3 |
3 |
100 |
|
4th quarter 2025 |
8 |
30 |
-22 |
7 |
7 |
100 |
|
Table 12. Start-up phase for initiated procedures - Veterinary medicines |
||||||
|
|
Average assessment time |
Target days |
Difference between assessment time and target days |
No. of cases measured |
No. of cases within target |
Share of cases within target in per cent |
|
Start-up phase for initiated procedures - VET |
No. of drug IDs |
|||||
|
1st quarter 2024 |
|
30 |
|
0 |
|
|
|
2nd quarter 2024 |
|
30 |
|
0 |
|
|
|
3rd quarter 2024 |
67 |
30 |
37 |
1 |
0 |
0 |
|
4th quarter 2024 |
|
30 |
|
0 |
|
|
|
1st quarter 2025 |
|
30 |
|
0 |
|
|
|
2nd quarter 2025 |
|
30 |
|
0 |
|
|
|
3rd quarter 2025 |
23 |
30 |
-7 |
1 |
1 |
100 |
|
4th quarter 2025 |
|
30 |
|
0 |
|
|
The assessment time is measured against the target time of 30 days for 2025 from the date when we receive the application until the procedure start date (day 0).
For further information, please contact Send an email.