The European Medicines Agency (EMA) has confirmed that the European Union (EU) clinical trial portal and database are fully functional. This sets the stage for the launch of the EU Clinical Trial Information System (CTIS) and the resultant application of the EU Clinical Trial Regulation from 31 January 2022.
This declaration of full functionality by the EMA’s Management Board comes following an independent audit of CTIS. The next step in the project involves the Board informing the European Commission (EC) of this outcome for the EC to independently verify that the features and functionality of the system meet the standards set in the Clinical Trial Regulation. Once satisfied, the EC will publish a notice in the Official Journal of the European Union. This is crucial as the EU Clinical Trial Regulation only applies six months following the date of publication of this EC notice. Since both the EMA and the EC wish that the system goes live on 31 January 2022, it is expected that the Commission notice will be published on 31 July 2021.
The Clinical Trial Regulation has been developed to harmonise the processes of registering and supervising clinical trials throughout the EU. CTIS will streamline these processes by providing a single entry point for EU clinical trial applications. The system has also been designed to benefit all stakeholders. It will allow sponsors, researchers and national competent authorities to communicate within the system to facilitate better knowledge and results sharing and enhance study design. Furthermore, a publicly accessible website within the system will ensure patients and healthcare workers are able to obtain detailed information on all clinical trials conducted in the EU.