Assessment times for new national applications for the licensing of medicinal products - 2026
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:
Completed cases
• Total assessment time
For Q2 2026, we make the following observations:
In 2026, we have completed 4 cases, of which 4 cases (100 %) were completed within the performance requirement of 240 days. In 2025, 60 % of all cases where finished within the performance requirement. It is expected that all cases completed in 2026 will finish within the performance requirement.
Total assessment times for completed cases
Status for 2026 as at end-June 2026: 4 cases for medicine have been completed, all cases for human medicines.
Total for human medicines
• 100 % of the cases finished within the performance requirement's maximum of 240 days (228 days on average).
Chart 1. Assessment times for completed cases
There were no completed cases in Q1 2025, Q3 2025 and Q2 2026
See table 1-3 for completed cases
|
Table 1. Total time for completed cases |
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|
|
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 |
|||||
|
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 |
|
1st quarter 2026 |
226 |
240 |
-14 |
4 |
4 |
100 |
|
2nd quarter 2026 |
|
240 |
|
0 |
|
|
|
Table 2. Total time for completed cases - Human medicines |
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|
|
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 |
|||||
|
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 |
|
1st quarter 2026 |
226 |
240 |
-14 |
4 |
4 |
100 |
|
2nd quarter 2026 |
|
240 |
|
0 |
|
|
|
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 |
|||||
|
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 |
|
1st quarter 2026 |
|
240 |
|
0 |
|
|
|
2nd quarter 2026 |
|
240 |
|
0 |
|
|
The total assessment time is measured against the target time of 240 days for 2026 from the date on which we receive the application until the date of determination (grant or refusal), excluding any clock-stop days.
For further information, please contact Send an email.