Valentina Ciurlia -

As of 31st January, 2022, the Clinical Trials Information System (CTIS) has gone live and thus the Clinical Trials Regulation EU/536/2014 (CTR) has become officially applicable.

The CTIS is the centralised EU online portal and database for regulatory submissions, authorisations and supervision of clinical trials across the EU/EEA.

With CTIS, clinical trial sponsors can:

  • Apply for a clinical trial in up to 30 EU/EEA countries with a single application
  • Facilitate involvement of trial participants by allowing easy expansion of trials to other EU/EEA countries
  • Collaborate across borders for better results and knowledge sharing
  • Ensure the EU/EEA remains an attractive location for clinical research investment
  • Fulfil all clinical trial publication requirements with no additional effort

Users with EMA accounts have a default role that will allow them to access CTIS and perform a limited number of activities. To perform additional actions relating to the CTs and, in accordance with their responsibilities, they need to be assigned specific roles by user administrators. This supports the proper management and oversight of the users using the system

CTIS has a total of 48 roles across the sponsor and authority workspaces including administrator and business roles.

There are two main approaches to manage a CTA in the CTIS:

Organisation centric approach:

  • it is intended for big organisations managing a high number of users and CTs.
  • It requires a formal registration process as the high-level administrator needs to be validated by EMA and appointed in the EMA Account Management portal.
  • It creates the opportunity to manage access and roles across trials

Trial-centric approach

  • it is expected to be used by non-commercial sponsors managing a small number of users and CTs.
  • It is the default approach if the organisation for which a CTA is created does not have a high-level administrator registered.

This increases the agility when submitting a CTA or when managing a small number of users.

Sponsors have a one-year grace period before they must submit all new clinical trial applications through this system. Starting from January 2025, all new and ongoing trials must go through CTIS.

Regulatory Pharma Net is ready to provide full support for the submission of Clinical Trial Applications and relevant amendments through the EU portal CTIS.

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