Fimea has defined further measures for non-transferred clinical trials

According to Directive 2001/20/EC, ongoing clinical trials must be transitioned to the CTIS portal in accordance with the EU Regulation (536/2014). The aim is for the trials to have been uploaded to the portal by 16 October 2024. The final deadline for the official approval of the transitions is 30 January 2025. An active trial (i.e. a trial that must be transitioned) refers to a trial in which there is ongoing treatment or follow-up of participants is utilising other data than register data. 

An attempt is being made to contact researchers through different channels. If the researcher cannot be reached through the personal email address reported to the authority, the next step is to contact the wellbeing services county’s research services. 

If the trial can not be transitioned, it becomes unlawful from 31 January 2025 and the authority will interrupt the trial. 

At the end of the transition period, Fimea will request an opinion from the sponsor and/or the researcher before the trial is discontinued. The opinion must be delivered within seven days. Thereafter, in accordance with Article 77 of EU Regulation 536/2014, the competent authorities of the EU Member States and the Commission will also be notified of the interruption.

If you wish to re-start the trial, a completely new application is required and will be evaluated as such in the CTIS portal. In this respect, it should be noted that the requirements of what should be included in the trial application differ from the previous EU directive.  
 

Read more about transitions:

Transition of clinical trials