Prices of clinical trials to be lowered in special cases

Fimea and Tukija have made a decision on the cases in which the fees for clinical trials can be adjusted or waived. The decisions are based on section 4 of the Decree on fees (194/2024), which entered into force on 1 May 2024.  Lower fees shall be charged depending how much the material which is submitted to the Clinical Trials Information System (CTIS) portal causes evaluation or administrative work for the authorities.

Waiving the fee is possible if the trial application expires for technical reasons, such as an interruption in the operation of the CTIS portal. In this case, the new application must be uploaded to the portal within one month.  The process must continue from the previous stage without adding new or further modified documents that were not included when the application expired.
Lowering the fee is possible in the following cases:

- The assessment of a significant change in Part I does not apply to Finland at all, and Finland is a member state concerned (MSC). Typical examples of this are patient facing documents in a foreign language related to the endpoints of the trial in Part I. Tukija does not assess the application. Fimea makes a decision also in these cases. 

•    The invoice sum is EUR 300 (normal fee EUR 1,400)

- The assessment of a significant change in Part I does not apply to Finland at all but Finland is a reporting member state (RMS). Typical examples of this are patient facing documents in a foreign language related to the endpoints of the trial in Part I. Tukija does not assess the application. Fimea makes a decision also in these cases and carries out the evaluation process in the portal.

•    The invoice sum is EUR 500 (normal fee EUR 2200)

- The evaluation of Part I is not included in Tukija’s tasks. These include significant modifications in labelling or in the evaluation of quality documentation only (IMPD-Q). However, the assessment of the application is the responsibility of Fimea.

•    When Finland is a reporting member state (RMS), the invoice sum is EUR 1,800 (normal fee EUR 2,200)
•    When Finland is a member state concerned (MSC), the invoice sum is EUR 1,000 (normal fee EUR 1,400)