European Regulation on clinical trials and CTIS

The way in which clinical trials are conducted in the European Union (EU) will fundamentally change with the entry into force of the Regulation on clinical trials [Regulation (EU) No. 536/2014] on 31 January 2022. This Regulation harmonises the processes for submitting, evaluating and monitoring clinical trials in the EU by means of the Clinical Trials Information System.

The CTIS will be the single point of entry for the submission of information on clinical trials in the EU and within the European Economic Area (EEA). The CTIS will include a sponsors’ workspace for clinical trial sponsors and the organisations that cooperate with them, an authority workspace for EU Member States, EEA countries and the European Commission, and a website for the general public.

In the secure workspace for sponsors, clinical trial sponsors will be able to access content which is useful for the preparation and compilation of applications for clinical trials and the related documents for submission.
The secure workspace for authorities will support EU Member States, EEA countries and the European Commission in the evaluation and overseeing of clinical trials.
The public website will provide detailed information on all clinical trials being conducted in the EU and EEA as of the date on which such trials are first entered and approved in the Clinical Trials Information System (CTIS).

The EU Member States and EEA countries will evaluate and oversee clinical trials within the framework of the CTIS, while the EMA will set up and maintain the CTIS. The European Commission will ensure that the Clinical Trials Regulation is properly interpreted and implemented in practice.

Transitional period

The Clinical Trials Regulation provides for a three-year transitional period to move to the Clinical Trials Information System (CTIS).

During the period from 31 January 2022 to 31 January 2023, sponsors of clinical trials can choose to submit their clinical trial applications in accordance with Directive (EC) No 2001/20/CE on clinical trials by making use of national submission processes, or, to use the CTIS as set out in the Regulation.
With effect from 31 January 2023, all new applications for clinical trials in the EU and EEA must be submitted via the CTIS in accordance with the Clinical Trials Regulation.
With effect from 31 January 2025, trials that have been approved in accordance with the Directive on Clinical Trials and that are still in progress will be subject to the terms of the Clinical Trials Regulation and transferred to the CTIS.

As soon as it is operational, EU Member States and EEA countries will have to work within the CTIS once applications have been submitted.

Important note for the attention of clinical trial sponsors

With effect from 31 January 2025, clinical trials authorised in accordance with the Directive on Clinical Trials⁽¹⁾ will be subject to the terms of the Regulation on Clinical Trials(2) and transferred to the Clinical Trials Information System (CTIS).

In this context, the European Medicines Agency has prepared a communication (Pdf, 90 Kb) to remind people of this deadline and explain how to access the various online resources (CTIS guidelines and training modules).

(1) Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the reconciliation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
(2) Regulation (EU) No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC

How will clinical trials be processed in the CTIS?

Clinical trial sponsors who want to obtain regulatory authorisation for a clinical trial in one or more EU Member States and EEA countries will submit a single clinical trial application form and supporting dossier via the Clinical Trials Information System (CTIS). Upon the submission of the single clinical trial application form and supporting dossier, the public registration of the clinical trial will also be provided.

For the Member States of the European Union, the EEA countries and sponsors, the CTIS will support them in their day-to-day operational processes throughout the life cycle of their clinical trials. The CTIS will perform regulatory oversight of clinical trials and provide monitoring and follow-up tools.

How do you register to use the CTIS?

Users must have an EMA account in order to use the CTIS. Users who already have an EMA account, in order to access EudraVigilance for example, or the database for substances, products, organisations and referentials (SPOR), do not need to create a new account. Users who do not already have an EMA account can register on the EMA Account Management platform.

Depending on the user management approach that they choose for the CTIS, organisations may have to carry out additional registration procedures. The organisation-based approach allows users to be managed by an administrator at the organisation level rather than for each individual trial. This is aimed at organisations that will be conducting several trials through the CTIS. Organisations that wish to use the organisation-based approach must ensure that they are registered in the EMA's Organisation Management System (OMS) and must also register a high-level CTIS administrator on the EMA Account Management platform.

How to prepare for the CTIS

The CTIS Sponsor Handbook provides sponsors with all of the information needed to prepare for the CTIS.

Additionally, sponsors can take advantage of the CTIS online training programme. The CTIS training materials catalogue, available on the training programme page on the EMA website, provides an overview of all the training on offer.

Last update 07.01.2026