The EMA’s Management Board, on April 2021 confirmed that the Clinical Trials Information System (CTIS) is fully functional and meets the agreed functional specifications. Following this, the European Commission issued a Commission Decision which specifies that the entry into application of the Clinical Trials Regulation (CTR) and hence the go-live date for the CTIS will be on 31 January 2022.
The CTR establishes a harmonized approach to submission, assessment, and authorisation of clinical trial applications as well as reporting and supervision of clinical trials with the implementation of consistent rules throughout the Member States. These processes are to be supported by an EU portal and EU database which will ensure a single-entry point with a workflow with monitoring and decision-making by the relevant parties.
The Clinical Trials Information System (CTIS) includes three main components that fulfill the needs of its different users:
- Submission workspace
- Authority workspace
- Public website
The system also includes an Application Programming Interface (API) for the clinical trials EUPD (CTAPI) for Member States.
If you want to learn more about the CTIS Go-Live Planning and its key areas, here you can read the full document from the European Medicines Agency.