How does the process for the clinical trial application request and for the clinical trial notification differ?
Clinical trials involving medicinal products for gene therapy, somatic or xenogeneic cell therapy or medicinal products containing genetically modified organisms, written authorization from Fimea is required before such clinical trial can commence. The amount of payment for an application is 3300 € according to the Ministry of Social Affairs and Health. The processing time for the application is 90 days.
Other clinical trials i.e. trials involving chemical or biological medicinal products, are subject to notification process. If no clarification is requested, the trial may commence without specific permission from Fimea when 60 days have elapsed from commencement of the processing. The amount of payment for a clinical trial notification is 3000 €.
A waiver of processing fee may be requested in respect of a notification
relating to a clinical trial on a medicinal product conducted without outside financing or with financing by a non-profit corporation. For more information, please see Administrative Regulation 8-2019 for clinical trials.