Fimea and Tukija to speed up evaluation of national clinical trials

The Finnish Medicines Agency Fimea and the National Committee on Medical Research Ethics (Tukija) have agreed on an accelerated evaluation procedure for clinical trials when the trial concerns only Finland. The new procedure will be introduced into use on 11 February 2026.

The accelerated evaluation process applies to all national applications, regardless of the phase or sponsor of the study.

The evaluation schedule is fixed and does not change on the basis of possible validation questions. The schedule is calculated from the date on which the clinical trial application is received in the CTIS portal. 

If no requests for additional information or corrections are needed during the evaluation phase, a decision on the trial may be made within 30 calendar days of its submission to the portal. 

- This is an important step in promoting clinical trials in Finland. The model was polished up together with Tukija. It differs from the practices of many other countries in that the calculation of deadlines already begins when the application is received in the portal,” says Kaisa Sunela, Head of Sector for Clinical Trials at Fimea.

In other countries, the calculation of days to the deadline typically does not start until the validation decision is issued.

- The evaluation procedures of the EU Clinical Trials Regulation have developed and have become very smooth over the past four years, so now is a good time to try faster processing of national trials,” says Outi Konttinen, General Secretary of Tukija.

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National clinical trial applications (in Finnish)