In brief

Starting from 31 January 2023, the Clinical Trial Information System (CTIS), provided for in Art. 80 of Regulation EU 536/2014, will become the single point of access for the submission, authorization and supervision of clinical trial applications in the EU and the European Economic Area (EEA) countries.

Key takeaways

The single portal was launched on 31 January 2022, initiating the one-year transition period during which sponsors could choose whether to submit a clinical trial application according to the Clinical Trials Directive or through the single portal. As of 31 January 2023, submission of clinical trial applications through the single portal will become mandatory.

Benefits expected from the use of the single portal are both for sponsors and other organizations involved in conducting clinical trials, which will be able to apply for a single authorization to conduct a clinical trial or manage a clinical trial already ongoing in the EU or EEA, and for national competent authorities and ethics committees of Member States, given that the single portal allows for coordinated assessment and supervision of individual clinical trials.

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Roberto Cursano leads the Rome Healthcare and Life Sciences practice.


Riccardo Ovidi can be reached at