The new Clinical Trials Regulation (Regulation (EU) No 536/2014) entered into application on 31 January 2022, repealing the Clinical Trials Directive (EC) No. 2001/20/EC and national implementing legislation in the EU Member States.
The Clinical Trials Regulation (CTR) harmonizes and streamlines the submission, assessment and supervision processes for clinical trials in the EU through the Clinical Trials Information System (CTIS).
The Clinical Trials Information System (CTIS) was launched on 31 January 2022, by the European Medicines Agency (EMA), and will be the single-entry point for submitting clinical trial information in the EU and the EEA (Iceland, Liechtenstein and Norway).
With the CTIS, clinical trial sponsors can apply for authorizations in up to 30 EU/EEA countries at the same time and with the same documentation.
CTIS is structured in:
- Two restricted and secured workspaces: Sponsor and Authority, only accessible to registered users
- A searchable database, accessible to the general public
The CTIS portal increases the transparency of information on clinical trials.
The Clinical Trials Regulation (CTR) foresees a 3-year transition period to CTIS, from 2022 to 2025:
- From 31 January 2022 to 30 January 2023: clinical trial sponsors could choose whether to submit their clinical trial applications under the Clinical Trial Directive 2001/20/EC through national submission processes, or under the CTR via CTIS.
- From 31 January 2023: All new clinical trial applications in the EU/EEA must be submitted in accordance with the CTR through CTIS.
- For trials authorized under the Clinical Trial Directive, sponsors can continue to submit substantial amendment following the principles of the Clinical Trial Directive.
- From 31 January 2025: all ongoing trials that were approved under the Clinical Trials Directive will fall under the Clinical Trials Regulation and will have to be transferred to CTIS.
Clinical trials are authorized at national level in the European Union EU/EEA. The Competent Authorities rely on the results of clinical trials carried out by pharmaceutical companies to reach their opinions on the authorisation of medicines.
In November 2022, ninety-nine (99) initial clinical trial applications were submitted to CTIS.
Note: Clinical trial: a study performed to investigate the safety or efficacy of a medicine. For human medicines, these studies are carried out in human volunteers.
Links:
- Clinical Trials website
- Clinical Trials Information System (CTIS) - Sponsor Handbook (v. 3.01, 20 December 2022)
- FAQs: Transition of trials from EudraCT to CTIS - CTIS Training Programme - Module 23 (version 1.3, January 2023)
- Sponsors' guide: Transition of trials from EudraCT to CTIS - CTIS Training Programme - Module 23 (version 1.3, January 2023)
Sources:
https://www.ema.europa.eu/en