CTD to CTR: Clinical Trials Regulation: ongoing trials beyond 31 January 2025
If you are running any clinical trials, approved under the Clinical Trials Directive, that will continue to run after 31 January 2025, you will need to comply with the Clinical Trials Regulation (Regulation (EU) No 536/2014) and must ensure you have transitioned the study, with recorded information about the trials on the Clinical Trials Information System (CTIS).
Clinical Trials Regulation – a recap
The Clinical Trials Regulation (CTR) came into force on 31 January 2022 with a transition period to 31 January 2023 for new clinical trials and up to 31 January 2025 for ongoing trials.
The CTR, which replaces the EU Clinical Trials Directive and local implementing legislation, provides the requirements for conducting clinical trials in member states of the European Union (EU).
The Regulation aims to harmonise EU clinical trial requirements and has a single point for communication with the competent authorities and ethics committees in the EU and the European Economic Area (EEA), the Clinical Trials Information System (CTIS), and will introduce:
- A simplified application process
- A streamlined process for review and authorisation
- A category of “low-intervention trials”
- New rules on protection of subjects and informed consent
- Transparency requirements
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The CTIS is the system enabling the implementation of the CTR and is the single-entry point for Clinical Trial Application (CTA) submissions, authorisations and supervision in the EU and EEA. Until 31 January 2025, all new CTAs must be submitted under the CTR in CTIS, and from 1 February 2025, all clinical trials authorised under the Clinical Trials Directive must either have ended or been transitioned to CTR via CTIS.
What you need to do
If you have trials that were approved under the CTD and are likely to continue to run after the 31 January 2025, you will need to comply with the CTR and ensure you have transitioned your study and recorded information about the trials on the Clinical Trials Information System (CTIS).
The team at Boyds has been routinely supporting trial sponsors ahead of the 2025 deadline. Our combined regulatory and clinical operations expertise enables us to complete Parts 1 and 2 of the CTA dossiers in the CTIS ensuring your trials can continue unaffected.
If you need advice or support to ensure you comply with the CTR, or for help with the CTIS, get in touch with a member of the team today.
For further information and a copy of our factsheet, click here.
