Assessment times for new national applications for the licensing of medicinal products 2017
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
Initiated cases with a completed start-up phase
- Assessment times of these cases
In 2017, we have completed 24 cases, of which 19 cases (79 %) where completed within the performance requirement of 240 days. In 2015, 64 % of all cases where finished within the performance requirement, while in 2016 77 % of all cases where finished within the performance requirements.
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 2017 as at end-December 2017: 24 cases have been completed, 20 cases for human medicines and 4 cases for veterinary medicines.
Total for human and veterinary medicines:
- 79 % of the cases finished within the performance requirement's maximum of 240 days (220 days on average).
- 71 % of the cases finished within the performance requirement's maximum of 30 days in the start-up phase (27 days on average).
- 79 % of the cases finished within the performance requirement's maximum of 210 days in the assessment and closing phases (194 days on average).
Human medicines:
- 80 % of the cases finished within the performance requirement's maximum of 240 days (218 days on average).
- 70 % of the cases finished within the performance requirement's maximum of 30 days in the start-up phase (25 days on average).
- 75 % of the cases finished within the performance requirement's maximum of 210 days in the assessment and closing phases (193 days on average).
Veterinary medicines:
- 75 % of the cases finished within the performance requirement's maximum of 240 days (231 days on average).
- 75 % of the cases finished within the performance requirement's maximum of 30 days in the start-up phase (37 days on average).
- 100 % of the cases finished within the performance requirement's maximum of 210 days in the assessment and closing phases (195 days on average).
See table 1-9 for completed cases
The total assessment time is measured against the target time of 240 days for 2017 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 2017 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 2017 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 2017 as at end-December 2017:
- Total for human and veterinary medicines: 100 % of the cases finished within the performance requirement's maximum of 30 days (8 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: There are no completed cases for Veterinary Medicines in 2017
Chart 2. Assessment times for initiated procedures
View table 10-12 for cases with an initiated procedure
The reason for that the aim of 30 days is not met in Q4 2016, is that one application unfortunately was not processed correctly and therefore delayed.
The assessment time is measured against the target time of 30 days for 2017 from the date when we receive the application until the procedure start date (day 0).