CTIS for authorities

The Clinical Trials Information System (CTIS) offers a secure workspace to support EU Member States, EEA countries and the European Commission in overseeing the conduct of clinical trials in the European Union (EU) and European Economic Area (EEA).

Target CTIS authority workspace users

  • National competent authorities of EU Member States and EEA countries
  • Ethics committees of EU Member States and EEA countries (national processes regarding access to CTIS for ethics committees may vary)
  • European Commission


  • Manage registered users and user roles
  • View clinical trial application dossiers
  • Manage tasks related to the assessment of clinical trials
  • Collaborate within and between Member States
  • Receive alerts and notifications for ongoing trials
  • Download documents submitted by clinical trial sponsors
  • Record inspections of sites and clinical trials
  • Conduct union controls

Getting started

Log in

Check with your organisation’s master trainer for CTIS whether you need to use the secure workspace. If you do, you can log in using your EMA account. If you have access to any EMA-hosted websites or online applications, you already have an EMA account and you should use the same credentials.

How to register

If you do not have an EMA account, you need to create an EMA account. Once your account is registered, you should ask your organisation’s administrator to assign you the roles and permissions you need to view and collaborate on clinical trial dossiers.

Training materials

Training and supporting materials are available for authority users on how to use the Clinical Trials Information System authority secure workspace.


Guidance and Q&As

Find questions and answers on how to use CTIS.

User support service

If you cannot find an answer to your question in the guidance and Q&As, please contact the User support service.

Website outages and system releases

See when this website and CTIS will be unavailable due to maintenance and upgrades, as well as an overview of system releases.