Today, the new EU Clinical Trials Regulation (Regulation (EU) No 534/2014 – “CTR”) becomes applicable. The CTR introduces a unified regulatory regime that will apply across the EU, with the goals of re-establishing the EU’s competitiveness in the field of scientific research and innovation, ensuring that clinical trial data are reliable and robust, and maintaining high standards of patient safety.
The CTR standardizes the procedures for obtaining approval and conducting clinical trials in the EU, introducing a single Clinical Trials Information System (“CTIS”) as well as other key changes to the regulatory framework established by the 2001 Clinical Trials Directive (“CTD”).
The CTR foresees a three-year transition period. Until 31 January 2023, sponsors may still choose to submit clinical trial applications under either the CTD regime or the CTR regime. Clinical trials which application is submitted under the CTD will continue to be regulated under the CTD until 31 January 2025. From 31 January 2023, submission according to the CTR becomes mandatory and, by 31 January 2025, all ongoing trials approved under the current CTD shall have to switch to the CTR and the CTIS.
Our report published in the European Pharmaceutical Law Review earlier this year provides an overview of the main changes brought by the new regulation which pharmaceutical companies sponsoring clinical trials in the EU and other stakeholders should be aware of.