Clinical trials: implementation of EU Regulation 536/14 starts

Following Commission Decision (EU) 2021/1240, on 31/07/2021 the notice confirming the achievement of full functionality and compliance of the EU portal and database on clinical trials (the so-called "Clinical Trials Information System" or "CTIS") provided for by the EU Regulation 536/2014 was published in the EU Official Journal.

From 31/01/2022, therefore, the "Clinical Trial Regulation" will finally be applicable in all Member States, given that the Regulation itself, in Article 99, provides for its full effectiveness six months after the publication of the notice of entry into operation of the CTIS by the EU Commission.

In any case, it should be remembered that, also based on what was indicated on 02/08/2021 by AIFA, EU Regulation 536/2014 provides for a transition period of three years. Member States will have to use the clinical trials information system immediately after the launch.

However, until 31/01/2023, applicants will still have the choice of submitting an application for the start of a clinical trial according to the current Directive 2001/20/EC, or according to EU Regulation 536/2014.

Thereafter, the submission of a clinical trial under the Regulation will become mandatory and, by 31/01/2025, all ongoing trials will have to be approved in accordance with the new legal framework.