CTR and the Clinical Trials Information System (CTIS)

On 31 January 2022, the new Clinical Trial Regulation (CTR) entered into force. The new regulation requires that all clinical trial applications and assessments be managed through a new, unified online portal known as the Clinical Trial Information System (CTIS): CTIS for sponsors - EMA (euclinicaltrials.eu). The CTIS is a one-stop, single point of entry for the submission of clinical trial information in the EU and the European Economic Area (EEA)

Important to note: due to the new regulation entering into force, applications for clinical trials that come under the regulation can no longer be submitted directly to the National Research Ethics Committee for Clinical Trials (NREC-CT) or to the Health Products Regulatory Authority (HPRA). Instead, they must be submitted using the CTIS. Documentation requirements will also change under the CTR. Please see further information on documentation under Part II National Requirements here.

For queries related to the CTIS, please contact the European Medicines Agency.

Submission via CTIS

CTIS contains a 'Sponsor' workspace for clinical trial sponsors and the organisations that work with them; an 'Authority' workspace for EU Member States, EEA countries and the European Commission; as well as a public-facing website.

  1. The 'Sponsor' secure workspace assists clinical trial sponsors in preparing for and compiling clinical trial applications and related documents to submit for assessment.
  2. The 'Authority' secure workspace supports the activities of EU Member States, EEA countries and the European Commission in assessing and overseeing clinical trials.
  3. The public website allows the wider public to access detailed information on all clinical trials conducted in the EU and the EEA (when trials begin to be submitted and approved in CTIS).

Roles and responsibilities

Transition period

Transition to CTIS has taken place over a three-year period, currently in the transition phase.

  • From 31 January 2023: all new clinical trial applications in the EU and EEA must be submitted under the Clinical Trials Regulation through CTIS.
  • From 31 January 2025: trials approved under the Clinical Trials Directive that are still ongoing must be transferred to both the Clinical Trials Regulation and CTIS.

How clinical trials will be processed in CTIS

  • Streamlining the submission process: clinical trial sponsors who wish to gain regulatory approval for a clinical trial in one or more EU Member State and EEA country submit a single clinical trial application form and supporting dossier through CTIS. The submission must also include the public registration of the clinical trial.
  • Supporting end-to-end business processes: CTIS supports the day-to-day business processes of EU Member States, EEA countries and sponsors throughout the lifecycle of a clinical trial by way of providing regulatory oversight of clinical trials and tools for supervision and monitoring.

How to register for CTIS

To access CTIS, clinical trial sponsors must ensure their users have an EMA account.

  • Those that have an existing EMA account i.e. to use Eudravigilance or the substances, products, and organisations database (SPOR) do not need to create a new account.
  • Those that do not have an EMA account can register via EMA Account Management. Clinical trial sponsors may need to complete additional registration steps based on the user management approach they choose for CTIS. The organisation-centric approach allows for the management of users by an administrator at the organisation level rather than at the level of an individual trial. It is intended for organisations that will run several trials in CTIS. To make use of the organisation-centric approach, organisations must ensure they are registered in EMA’s Organisation Management System (OMS), and they must register a CTIS High Level Administrator via EMA Account Management.

Using CTIS as a sponsor

  • As a first step, we recommend clinical trial sponsors consult the sponsor handbook for guidance on preparing for CTIS. Tailored specifically for pharma, research organisations, SMEs and academic sponsors, it covers priority topics for clinical trial sponsors and links to supporting materials.
  • Familiarise with the workings of CTIS by completing the online training programme. It consists of several modules covering the full lifecycle of clinical trial submission.
  • Watch back on this information day that prepares CTIS users for submitting and evaluating clinical trial applications in the system when it goes-live.

Useful links to resources & training materials

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