Development of the Clinical Trials Information System

The European Union (EU) Member States and European Economic Area (EEA) countries, European Commission and European Medicines Agency (EMA) launched the Clinical Trials Information System (CTIS) on 31 January 2022. 

At the same time, EMA launched a searchable public website enabling anybody to view information on clinical trials in the EU and EEA contained in the CTIS database.

CTIS serves to implement EU pharmaceutical law set out in the Clinical Trials Regulation (Regulation (EU) No 536/2014).

A risk mitigation plan is available to help CTIS users carry out regular activities within the system in different risk scenarios.

EMA monitors its implementation to ensure:

• early identification, classification and assessment of risks;
• coordinated, rapid and effective response;
• user compliance with the Clinical Trials Regulation.

The Agency published the CTIS risk mitigation plan in February 2023. For its set up, EMA worked together with Members States and the European Commission.

For more information:

• Clinical Trials Regulation
• Clinical Trials Information System
• Clinical Trials website

The Clinical Trials Regulation requires all information stored in the CTIS database to be publicly available, unless exempted to protect the following:

• Personal data
• Commercially confidential information (in particular the marketing-authorisation status of a medicine, unless there is an overriding public interest)
• Confidential communication between EU Member States during evaluations
• Supervision of clinical trials by EU Member States

The EMA Management Board endorsed two EMA documents in 2015 that provide further detail on exemptions: 

In March 2022, the 'CTIS highlights' newsletter became the 'Clinical Trials highlights' newsletter. It will continue to cover CTIS but will also include topics such as the business change programme ACT EU. 

EMA's ‘CTIS newsflash’ contains short updates on system usage, key facts and figures, hints to help users with specific features and links to reference materials, following the launch of CTIS on 31 January 2022.

To receive the newsletter directly by email, please contact ct.newslettersubscriptions@ema.europa.eu.

The three most recent issues are available below. For previous issues, see:

• Newsletters

During the development of CTIS, EMA provided regular progress updates to its Management Board. For further details, see Highlights of EMA Management Board meetings. 

EMA originally published the CTIS functional specifications in December 2014, following a public consultation, to be formally audited in line with the Clinical Trials Regulation.

An initial go-live in December 2015 was postponed due to technical difficulties with the development of the IT system. 

In March 2019, the IT supplier submitted a revised project plan and EMA revised the CTIS project methodology and delivery plan. 

From June 2019, the development of CTIS followed an agile framework and iterative delivery model, with functionalities delivered in short development cycles and an improved stakeholder engagement model. 

In April 2021, EMA's Management Board confirmed that the system met the agreed requirements following an independent audit of CTIS. 

On 31 July 2021, the European Commission confirmed 31 January 2022 as the date of entry into application of the Clinical Trials Regulation and the go-live of CTIS, by publishing a notice in the Official Journal of the European Union. 

EMA worked towards go-live on 31 January 2022 by focusing on the following areas:

• Findings of the independent system audit
• Improving usability, quality and stability
• Knowledge transfer to prepare users and their organisations

More details are available in the documents below. 

EMA continues to regularly engage with external stakeholders on CTIS development and change management matters, before and after go-live, under the stakeholder engagement model in place since 2019. 

Nominated experts representing national competent authorities, ethics committees, clinical trial sponsors, healthcare professionals, patients and the general public were able to test, review, select and verify CTIS functionalities.

During development, EMA consulted EU Member States, the European Commission and stakeholders representing clinical-trial sponsors (including micro, small and medium-sized enterprises (SMEs) and academic organisations), healthcare professionals and patient groups on its proposals, including on:

• the draft functional specifications in 2014;
• implementing the transparency rules in 2015. 

More background information is available in the documents below.

The European Commission published guidance documents for public consultation in 2016. For more information, see:

• Risk proportionate approaches in clinical trials
• Summary of Clinical Trial Results for laypersons
• Definition of investigational medicinal products and use of auxiliary medicinal products
• Ethical considerations for clinical trials on medicinal products conducted with minors
• European Commission: Clinical trials - Major developments