Search for:

In brief

Following the extraordinary meeting held on 21 April 2021, the EMA’s Management Board confirmed that the clinical trial EU Portal and Database is now fully functional and on track to go live by 31 January 2022.


In particular, the Portal and the EU Database, on whose full functionality depends the application of Regulation EU No. 536/2014 on clinical trials, represents the key component of the Clinical Trial Information System (CTI), an information system that will be the single entry point for submitting clinical trial applications.

The CTIS will therefore allow sponsors to apply for a clinical trial in all countries of the European Economic Area (EEA) with one application instead of having to apply separately in every country in which a trial is conducted and will also facilitate the recruitment of trial participants by allowing sponsors and researchers to easily expand trials to other EEA countries.

The CTIS, which shall be managed by the EMA, will contain a public website with detailed information on and outcomes of all clinical trials conducted in the EU throughout their lifecycle, thus improving transparency and access to information for patients, healthcare workers and other stakeholders.

Following verification of the full functionality of the EU Portal and Database (on the basis of an independent audit report), the EMA shall inform the Commission, which, once satisfied that the relevant functional specifications have been fulfilled, will publish a notice in the Official Journal of the EU. Six months after the publication of the aforementioned notice, Regulation EU No. 536/2014 shall apply.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

Write A Comment