The Clinical Trials Regulation (CTR; EU No 536/2014) will replace the EU Clinical Trial Directive (2001/20/EC) and is set to take effect on 31 January 2022. This new regulation harmonizes the application and supervision of clinical trials in the EU by utilizing a new centralized online portal called the Clinical Trials Information System (CTIS).
The CTIS will be the single-entry point for submitting clinical trial applications and information in the EU, facilitating collaboration and information sharing between sponsors and regulators. Clinical trial information, such as overviews of the study design and results, will also be available to the public.
Together with CTIS, the CTR will increase efficiency, consistency and transparency throughout the clinical trial process across EU member states. This will not only make the EU more attractive for clinical research, but will ultimately increase the quality and safety of clinical trials.
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