CTIS serves to implement EU pharmaceutical law in the Clinical Trials Regulation (Regulation (EU) No 536/2014).
The European Medicines Agency (EMA) maintains CTIS and the public website, together with the EU Member States, EEA countries and European Commission.
CTIS supports interactions between clinical trial sponsors (researchers or companies that run a clinical trial and collect and analyse the data) and regulatory authorities in the EU Member States and EEA countries, throughout the lifecycle of a clinical trial.
Anybody can view information held in CTIS on clinical trials in the EU and EEA, by using the searchable public website.
Access the public information and secure workspaces in CTIS:
For more information on the legal framework, see:
The public website has a search function which anybody can use to find detailed information on clinical trials from 31 January 2022, based on the information contained in the Clinical Trials Information System (CTIS).
Search for information in CTIS via the link below:
Via this website, anybody can view information on individual clinical trials as soon as it becomes available, such as the following:
Information on individual clinical trials initiated before 31 January 2023 under the Clinical Trials Directive is available:
The Clinical Trials Regulation requires information stored in the CTIS database to be publicly available, unless exempted to protect the following:
A clinical trial map is available to help patients and healthcare professionals locate clinical trials conducted in their area. It also enables searches by medical condition.
Its search function supports queries in lay language.
CTIS launched the clinical trial map in March 2025. This is in line with the Accelerating Clinical Trials in the European Union (ACT EU) initiative workplan for 2025-2026.
The trial map is available on the CTIS public portal:
For more information, see:
CTIS supports the business processes of clinical trial sponsors and national regulators via secure workspaces.
Access the sponsor workspace in CTIS:
Clinical trial sponsors can use CTIS to apply for authorisation to run a clinical trial in up to 30 EEA countries via a single online application.
They can also carry out tasks including liaising with national regulators while a trial is ongoing and recording clinical trial results.
National regulators can use CTIS to collaborate on the evaluation and authorisation of a clinical trial in several EU/EEA countries.
They can also use it alongside other systems to work together on clinical trial oversight, including monitoring and assessing safety-related data in the context of a clinical trial.
The sponsor workspace is a single online portal for clinical trial sponsors and other organisations involved in running clinical trials to apply to carry out a trial in the EU Member States and EEA countries, submit data related to a trial and post trial results.
Access the sponsor workspace in CTIS:
It has the following functionalities:
It is for the following target users:
For more information, see the infographic for sponsors:
The authority workspace enables EU Member States, EEA countries and the European Commission to use CTIS to oversee the conduct of clinical trials in the EU/EEA.
Access the sponsor workspace in CTIS:
It has the following functionalities:
It is for the following target users:
Information on clinical trials submitted in CTIS is made available on the CTIS public portal, in line with revised CTIS transparency rules applicable as of June 2024.
Revised transparency rules apply as of 18 June 2024 for publishing information on clinical trials submitted through CTIS.
The revised rules enable easier access to clinical trial information and ensure a balance between transparency and protection of commercially confidential information.
These changes benefit patients, healthcare professionals and clinical trial sponsors.
EMA also launched a new version of the CTIS public portal on 18 June 2024.
EMA's Management Board adopted the revised rules in October 2023.
A quick user guide provides a summary of the revised CTIS transparency rules:
For further details on disclosure rules, protection of personal data and commercially confidential information, see the Accelerating Clinical Trials in the EU (ACT EU) website:
The CTIS Simplification Task Force works to help the Clinical Trials Information System become more efficient and future-proof.
The task force aims to:
The task force focuses on analysing topics prioritised based on user feedback.
It consults stakeholders on a case-by-case basis. This helps reflect their needs in proposals for system modernisation.
The task force expects the proposed changes to be implemented in CTIS from 2026.
In this process, EMA informs stakeholders in advance and offers support via training events and materials.
EMA set up the task force in early 2024 in collaboration with the Heads of Medicines Agencies (HMA) and the European Commission.
For more information, see the document below:
The task force includes members from:
Peter Arlett (EMA) and Marianne Lunzer (CTIS Member State product owner) co-chair the task force.
A joint controllership arrangement describes the processing of personal data in CTIS, in accordance with the General Data Protection Regulation and EU Data Protection Regulation.
A range of actors may need to enter personal data into CTIS as part of clinical trial authorisation and supervision processes, including clinical trial sponsors, marketing authorisation applicants or holders, the European Commission, EMA, EU Member States and EEA countries.
The joint controllership arrangement describes the roles and responsibilities of each party regarding the processing of personal data in CTIS. It sets out the measures they must put in place to ensure that personal data in CTIS is securely processed, and covers how the parties are to handle any personal data breaches.
When accessing CTIS for the first time, CTIS workspace users will be made aware of the contents of the joint controllership arrangement before proceeding.