In brief
With a decision published in the EU Official Journal on 31 July 2021, the European Commission confirmed that the EU Portal and Database have achieved full functionality. This implies that Regulation (EU) No. 536/2014 on clinical trials will be applicable as of 31 January 2022, in accordance with the provisions of Article 99 of the same Regulation.
In depth
The EU Portal and Database represent the key components of the Clinical Trial Information System (CTIS) introduced by Regulation (EU) No. 536/2014, which will be the single entry point for the submission of data and information relating to clinical trials in the EU and in the European Economic Area (EEA).
Moreover, through the CTIS, sponsors will no longer be required to submit separate applications in each EEA country where the trial is conducted, but will be able to apply for a clinical trial authorization in more than one country by submitting one single application. The CTIS will also facilitate the recruitment of trial participants by allowing sponsors and investigators to easily extend trials to other EEA countries and achieve better results through knowledge sharing.
