New Decree on fees chargeable for clinical trials under the EU Clinical Trials Regulation to enter into force on 1 May 2024

The Ministry of Social Affairs and Health has adopted a Decree on fees chargeable for trials (194/2024) in accordance with the EU Clinical Trials Regulation (536/2014). The Decree applies to the fees charged for applications to clinical trials on medicinal products intended for human use under the EU Clinical Trials Regulation. The Decree on fees chargeable will enter into force on 1 May 2024, and it will apply to research applications submitted to the authorities via the CTIS portal on the date when the Decree enters into force or after this.

As before, no fees will be charged for researcher-driven drug trials, under the terms specified in the decree on fees. New services subject to a fee have been added including the transfer of a study in accordance with the Directive to comply with the EU Regulation (a so-called transition study) and the assessment of the Annual Safety Report in accordance with the EU Regulation when Finland is a SaMS (safety assessing member state).

As a result of the application of the EU’s Clinical Trials Regulation, the evaluation cooperation between the National Committee on Medical Research Ethics Tukija and the Finnish Medicines Agency Fimea has changed. One fee will be charged for the ethical and scientific evaluation of the trials referred to in the Clinical Trials Regulation, which will be divided between Fimea and Tukija.
The fees for variation applications for drug trials under the Directive remain unchanged, as the amendments entered into force on 1 January 2024.

Fimea's expenditure is mainly covered by fees generated by supervisory and service activities. The fees charged for the activities and services correspond to the costs incurred to the government for producing them.

Read more:

Chargeable fees for trials under the EU Clinical Trials Regulation (536/2014) (194/2024) (pdf, in Finnish)

Explanatory memorandum (pdf, in Finnish)

Trials under the EU Regulation

Transition of clinical trials