National clinical trial applications

EN Kansalliset tutkimushakemukset

For national clinical trial applications sent only to Finland, an accelerated evaluation schedule is followed, with a fixed schedule for different phases. The progression of the schedule starts from the arrival of the application in the CTIS portal, and progression is not affected by issues such as questions in the validation phase.

Friday is not recommended as the date of submission of the application. If the application is sent to the portal on a Friday, during a weekend or on a midweek holiday, the delivery date is calculated as the next working day (D0). Application handling fees, obligations and other activities remain the same compared to multinational studies. See "Trial application and modifications".

The day on which the trial application is sent to the portal is counted as day 0. On the third calendar day from day 0, any validation questions posed are sent to the sponsor, and are to be answered in 10 days. The questions in the evaluation phase, from Parts 1 and 2, arrive in 30 calendar days starting from when the application is received within the portal. The sponsor has 12 days to respond, and the authorities have 10 days to evaluate the responses. After this, the decision will be posted in the portal on the subsequent calendar day. If there is a need for questions in the second round, these will be sent if necessary, and the decision schedule will be adjusted accordingly.

Below is a table describing the processing phases for the application sent to the portal, according to what day of the week is in question. Week 1 is the week when the application is submitted. If the sponsor’s response arrives on a midweek holiday, the portal will not delay this. This should be taken into account in the trial application submission schedule.

Phase Monday Tuesday Wednesday  Thursday Friday
Validation questions will follow Week 1, Thursday Week 1, Friday Week 2, Monday Week 2, Monday Week 2, Thursday
Answering the validation questions Week 3, Monday Week 3, Monday Week 3, Thursday Week 3, Thursday Week 4, Monday
Answering the validation questions Week 5, Wednesday   Week 5, Thursday Week 5, Friday Week 6, Monday Week 6, Wednesday
Evaluation questions arrive/ decision if no questions Week 7, Monday Week 7, Tuesday Week 7, Wednesday Week 8, Monday Week 8, Monday
Evaluation questions processed Week 8, Thursday Week 8, Friday Week 9, Monday Week 9, Thursday Week 9, Thursday
Decision if evaluation questions have been sent Week 8, Friday Week 9, Monday Week 9, Tuesday Week 9, Friday Week 9, Friday

Substantial modifications in national application processes

In accordance with the accelerated schedule, the clinical trial applications whose initial assessment has also been accelerated will be processed accordingly--in other words, this accelerated process will apply to applications initiated on 11 February 2026. Other applications will be processed according to the normal CTIS portal schedule. In case of substantial modifications, the progression of the schedules works in the same way with respect to the submission of the substantial modifications application to the portal. The table for initial applications is otherwise valid, but the evaluation questions and the subsequent process take place one week earlier.

The day on which the application is submitted to the portal is counted as day 0. On the third calendar day from day 0, any validation questions posed are sent to the sponsor, and are to be answered in 10 days. The questions in the evaluation phase, from Parts 1 and 2, arrive in 23 calendar days starting from when the application is received within the portal. The sponsor has 12 days to respond, and the authorities have 10 days to evaluate the responses. After this, the decision will be posted in the portal on the subsequent calendar day. If there is a need for questions in the second round, these will be sent if necessary, and the decision schedule will be adjusted accordingly.