Human regulatory

Development of the Clinical Trials Information System

Table of contents

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.

Transparency requirements

The Clinical Trials Regulation requires 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 documents in 2015 that provide further detail on exemptions: 

Update: EMA has revised its transparency rules 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.

The revised rules will apply once they have been implemented in CTIS, which is expected in the second quarter of 2024. The PDF icon appendix on disclosure rules  continues to apply until the revised rules are implemented.

EMA's Management Board adopted the revised CTIS transparency rules in October 2023. 

They were available for public consultation between May and June 2023.  

For more information, see:

Progress updates

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

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

Development timeline

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 date was published in December 2015 but this date 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. 

    Stakeholder engagement and consultation

    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.

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