Application procedure for clinical drug trials will change
From January 31, 2023, all new clinical drug trials will be submitted through the CTIS (Clinical Trials Information System) of the European Medicines Agency EMA.
The change is based on tthe Clinical Trials Regulation (EU) No 536/2014 (CTR), which came into application on 31 January 2022. The Regulation is designed harmonise the processes for application, assessment and supervision of clinical trials in the EU.
Read more on Fimea's website.