On 31 January 2023, the use of Clinical Trials Information System (“CTIS”) will become mandatory for all clinical trial sponsors submitting initial applications for the approval of their clinical trials in the European Economic Area (“EEA”). This means that, as of that date, all new applications for the approval of clinical trials must be submitted and reviewed in accordance with the Clinical Trials Regulation (“CTR”).
The CTIS is the centralized EU portal and database established by the CTR as the single electronic entry point for sponsors to submit documentation and data relating to clinical trials. This includes applications for approval of clinical trials, clinical data records, safety reporting, corrective measures, modifications, additional information requested by the reporting Member State and notifications. The purpose of a common entry point for submission of documentation related to clinical trials was to streamline and facilitate the exchange of information among the competent authorities of EEA countries and between clinical trial sponsors and the competent authorities of EEA countries, harmonize application procedures and oversight and assessment processes and enhance transparency in relation to clinical trial data.
For practical information on the use of CTIS, the EMA has developed a CTIS Sponsor Handbook to support clinical trial sponsors in navigating the submission of information related to their clinical trials to CTIS.