Application procedure for clinical drug trials will change
From 31 January 2023, all applications for clinical drug trials will be submitted through the Clinical Trials Information System (CTIS) of the European Medicines Agency (EMA).
This change is based on the 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.
A three-year transition period to CTIS
CTR sets a three-year transition period to use CTIS. The transition period for new applications will end on 30 January 2023 at 4:15 pm. From 31 January 2023, all applications for new academic and commercial clinical drug trials in the EU and EEA must be submitted through CTIS under CTR.
Between 31 January 2022 and 30 January 2023, the sponsors of clinical drug trials can choose whether to submit applications for clinical drug trials through national application procedures under the Clinical Trials Directive 2001/20/EC (CTD) or via CTIS under CTR.
From 31 January 2025, any ongoing drug trials approved under CTD will need to comply with CTR and be transferred to CTIS by 30 January 2025.
EudraCT not used for trials approved under CTR
From 31 January 2023, new EudraCT numbers and new applications for trials in the EU/EEA cannot be created in EudraCT. Until 31 January 2025, applications for trials under CTD can be modified for trials created before 31 January 2023.
CTIS training by Fimea and Tukija
Together, Fimea and the National Committee on Medical Research Ethics (Tukija) have and will arrange webinars on CTR and CTIS. The next training session is on 18 January 2023. We will provide more information closer to the event.
- Marita Kailajärvi, Senior Medical Officer, tel. 02952 23355
- Paula Koivumäki Clinical Trials Coordinator, tel. 0295223343