EU Clinical Trials Regulation will make drug studies more transparent

Drug research in Europe will have more transparency now that the clinical trials information system (CTIS) is fully operational, according to the European Medicines Agency (EMA).

The CTIS has been operational since 2022; however, it only became fully functional last week when the EU Clinical Trials Regulation (CTR) came into effect.

According to an EMA statement on Jan. 31, “From today, all clinical trials in the European Union (EU), including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive, are governed by the Clinical Trials Regulation.

“This marks the end of a three-year transition period, during which more than 5,000 clinical trials were transitioned to the CTR through submission to the CTIS, the single-entry point for sponsors and regulators for the submission and assessment of applications for clinical trials in the EU.”

The CTIS is a searchable database for healthcare professionals, patients, and the general public. The idea is to make the results of clinical trials more transparent, in line with the aims set out in the CTR.

Ongoing studies not already moved to the CTIS may now be subject to “corrective measures,” according to the EMA, which pointed out that transition procedures are no longer available and that instead, sponsors must submit a new application.

Trial destination

Combined the CTR and CTIS will encourage sponsors to run drug studies in the EU according to the EMA, which wrote “The regulation streamlines the processes for the application and supervision of clinical trials, and their public registration.

“All clinical trial sponsors use the same system and follow the same procedures to apply for the authorization of a clinical trial, no matter where they are located and which national competent authority or national ethics committee they are dealing with.”

Unsplash/Alexandre Lallemand