The Clinical Trial Regulation (CTR) is a regulation of the European Union (EU) that sets out the rules for the conduct of clinical trials of medicinal products for human use.
The regulation was adopted in 2014 and entered into application on 31 January 2022.
The CTR aims to simplify and harmonize the procedures for conducting clinical trials in the EU, while ensuring the safety and protection of trial participants and maintaining the reliability and robustness of trial data.
It establishes a single authorization procedure for conducting clinical trials in the EU, with the European Medicines Agency (EMA) as the central regulatory body responsible for the authorization and oversight of clinical trials.
Under the CTR, sponsors of clinical trials must submit a clinical trial application to the EMA, which will review the application and provide a decision on whether to grant authorization for the trial.
The CTR also sets out requirements for the conduct of clinical trials, including the informed consent of trial participants, the use of appropriate study designs and statistical methods, and the reporting of trial results.
The CTR is an important piece of EU pharmaceutical legislation, as it aims to improve the efficiency and competitiveness of the EU pharmaceutical industry while ensuring the highest standards of safety and protection for patients involved in clinical trials.
