Welcome to the September 2023 issue of the Clinical Trials Highlights.

The ACT EU website is now live, providing information on the ongoing activities for smarter clinical trials through regulatory, technological and process innovation. The website will be a key resource on clinical trials in the EU for patients, sponsors and regulators. We would be happy to receive any feedback on the website via the available contact form.

One of the priorities of ACT EU is to monitor the implementation of the Clinical Trials Regulation (CTR) and the operation of the related Clinical Trials Information System (CTIS). Since the launch of CTIS on 31 January 2022, over 2100 initial clinical trial applications have been submitted and over 1000 clinical trials have been authorised under the CTR.

Sponsors are already preparing for the next phase of implementation of the CTR. By 30 January 2025, any ongoing trials approved under the previous legal framework, the Clinical Trials Directive, will fall under the CTR. Therefore, any trials will need to be transferred to CTIS and approved by 30 January 2025 if they are ongoing. Sponsors have already submitted over 300 transitional trials to CTIS. 

The European Medicines Regulatory Network continues to support sponsors in the transition of their ongoing trials via dedicated events, training material and guidance documents. Key information and relevant materials are available in a new section of the CTIS website.