Piloting of the EU Regulation on Clinical Trials ends in Finland
Fimea and Tukija started in November 2020 the piloting of the new clinical trials assessment process in accordance with the EU Regulation.
Now the project has reached the final stage. The deadline for submission of applications regarding new clinical trials and substantial modifications in the pilot project is September 27, 2021.
Sponsors may express their interest in participating the pilot in the cover letter accompanying the advance notification filed with Tukija or via email (info(at)tukija.fi).
More information on participating in the pilot and other instructions can be found at https://www.fimea.fi/web/en/supervision/clinical_drug_trials/euregulation.