Clinical Trials Regulation: Safety, transparency and efficiency of clinical trials in Europe
The Clinical Trials Regulation applies to all clinical trials in the EU involving medicines for human use. It came into effect on January 31, 2022, replacing the previous Clinical Trials Directive.
This Regulation's main goal is to simplify the process for sponsors running clinical trials in Europe, while ensuring the highest standards of safety and transparency.
How the Regulation improves clinical trials
Consistency
The process for reviewing new clinical trial applications and overseeing ongoing trials is now the same in all EU countries.
Efficiency
It makes it easier for sponsors to apply to run a clinical trials in Europe by allowing them to submit one application to run trials in multiple countries.
Transparency
The regulation makes clinical trial information available to the public on a dedicated website.
Safety
It ensures high safety standards for all participants in clinical trials.
How CTIS increases efficiency and transparency
The Clinical Trials Information System (CTIS) is an online platform launched on January 31, 2022, under the Clinical Trials Regulation. It simplifies the application and supervision process for clinical trials across the EU.
One application
Sponsors can apply for clinical trial approval in up to 30 European countries with one online application.
Joint review
Regulators in different countries can work together to assess and approve clinical trial applications, making the process faster.
Transparency
A public website where anyone can find information about clinical trials in the EU.
Manage from start to finish
Sponsors can use CTIS to manage every part of a clinical trial, from applying for approval to run the trial, to recording results and responding to regulatory requests.
Find a clinical trial in Ireland
Find information about clinical trials in Ireland and find contact details for the sponsors.
Learn more