About this website

All ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025. This date marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU.

Sponsors of clinical trials expected to continue after 30 January 2025 must consider the time required for Member States to complete the authorisation procedure, which can take up to three months. To help streamline the process, Member States will implement, where possible, an expedited procedure for transitioning trials to the CTR. Ongoing clinical trials do not need to be halted or ended during the transition from the previous legal regime, the Clinical Trials Directive (CTD), to the Clinical Trials Regulation.

To help sponsors make the transition, there is guidance available, a best practice guide for sponsors of multinational clinical trials, and additional support materials. Dedicated training activities have also been organised.

The application of the CTR strengthens Europe as an attractive location for clinical research. 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 authorisation of a clinical trial, no matter where they are located and which national competent authority (NCA) or national ethics committee they are dealing with.

The authorisation and oversight of clinical trials is the responsibility of EU / EEA Member States while the European Medicines Agency is responsible for maintaining CTIS. The European Commission oversees the implementation of the Clinical Trials Regulation.

A clinical trial is a study performed to investigate the safety or efficacy of a medicine. For medicines intended for human use, these studies are carried out in people who volunteer.

Clinical trials in the EU and EEA are governed by the Clinical Trials Regulation (Regulation (EU) No 536/2014) which came into application on 31 January 2022. It is part of a broad initiative to transform the EU/EEA clinical trials environment in support of large clinical trials in multiple European countries, to the benefit of medical innovation and patients.

The regulation of clinical trials aims to ensure that the rights, safety and well-being of clinical trial participants are protected and the results of clinical trials are reliable and informative.

• Clinical trial sponsors (usually researchers or companies that oversee a clinical trial and collect and analyse the data) can use this website to apply for permission to run a clinical trial anywhere in the EU/EEA including in multiple countries, provide updates to national regulators about a trial, and submit trial results.
• EU/EEA national regulators can use it to process clinical trial applications collaboratively, request further information, authorise or refuse a trial and oversee an authorised trial.
• Anybody can use it to view information on clinical trials in the EU and EEA from 31 January 2022.

Clinical trial sponsors and EU/EEA national regulators work in the Clinical Trials Information System, the system underpinning this website.

The EU Member States and EEA countries, the European Commission and EMA launched the Clinical Trials Information System on 31 January 2022. On the same day, EMA launched this website. EMA maintains this website in collaboration with the EU Member States and EEA countries, and the European Commission.

CTIS is a registered data provider for the World Health Organization (WHO). Data from authorised trials published on this website is included in the search portal of WHO's International Clinical Trials Registry Platform (ICTRP). This applies to relevant clinical trial data, as required by WHO, which has been published on CTIS since the launch of the system on 31 January 2022.

Publicly accessible registries that are data providers to WHO's ICTRP are accepted by the International Committee of Medical Journal Editors (ICMJE), according to its recommendations.

For more information on the regulation of clinical trials in human medicines, see:

This website supports the business processes of clinical trial sponsors and national regulators throughout the lifecycle of a clinical trial, via the secure Sponsor workspace and Authority workspace Users need to log into these secure workspaces.

Clinical trial sponsors can apply for authorisation to run a clinical trial in up to 30 EEA countries via a single application in this website. They can also carry out tasks including liaising with national regulators while a trial is ongoing and recording the results of the trial.

National regulators can work together using this website on the assessment and authorisation of a clinical trial in several countries.

They can also use this website together with other systems to work together on clinical trial oversight, including monitoring and assessing safety-related data in the context of a clinical trial.

To find detailed information on clinical trials granted or refused permission in the EU and EEA via the Clinical Trial Information System, this website has a search function.

You can view information on individual clinical trials as soon as it becomes available, such as the EU clinical trial number, name and address of the trial sponsor, start and end dates of participant recruitment and of the trial itself.

Further information, including the identity of the investigational medicine and details of the trial design, is also made available via this website, but its publication may be deferred to protect legitimate economic interests.

The Clinical Trials Information System, the system underpinning this website, serves to implement EU pharmaceutical law in the Clinical Trials Regulation (Regulation (EU) No 536/2014). The goal of the Regulation is to create a favourable environment for conducting clinical trials in the EU, to ensure the EU remains an attractive region for clinical research, with the highest standards of safety for participants and transparency of information.

It does this by harmonising the submission, assessment and supervision processes for clinical trials supported by this website. Before the launch of this website, sponsors had to submit clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval to run a clinical trial.

The EU Member States and EEA countries, the European Commission and EMA launched the Clinical Trials Information System on 31 January 2022. On the same day, EMA launched this website. EMA maintains this website in collaboration with the EU Member States and EEA countries, and the European Commission.

The assessment, authorisation and supervision of clinical trials are the responsibilities of EU Member States and EEA countries.

All ongoing clinical trials in the European Union (EU) must be transitioned to the Clinical Trials Information System (CTIS) by 30 January 2025. This date marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU.

Sponsors of clinical trials under the Clinical Trials Directive expected to continue after 30 January 2025 must consider the time required for Member States to complete the evaluation procedure, which can take up to three months. To help streamline the process, Member States will implement, where possible, an expedited procedure for transitioning trials to the CTR. Ongoing clinical trials do not need to be halted or ended during the transition from the previous legal regime, the Clinical Trials Directive, to the Clinical Trials Regulation.

Learn more about transitional trials from this quick guide for sponsors.

For more information on how to transition your clinical trial, check out the available guidance and training materials.