End of Clinical Trials Regulation Transition

On July 12, Infarmed issued an Informative Note concerning the transition periods of Regulation no. 536/2014, of April 16, regarding medicines for human use (the “Clinical Trials Regulation”).

In essence, as the Portuguese authority on clinical trials, Infarmed reminds that any clinical trials approved under Directive 2001/20/EC, of April 4, 2001 (“Clinical Trials Directive”) that continue running in that date will need to comply with the Clinical Trials Regulation as of January 30, 2025, and their sponsors must ensure that they have recorded information on the clinical trials in the European platform created by the Clinical Trials Regulation (the Clinical Trials Information System, also known as CTIS).

This means that, as of January 30, 2025, all clinical trials carried out on national territory must comply with the Clinical Trials Regulation, otherwise they will be considered non-compliant and subject to penalties.

Infarmed clarifies that sponsors that still have clinical trials authorized under the Clinical Trials Directive shall act immediately to conform these with the Clinical Trials Regulation, namely through the submission of information via CTIS. In this context, the Portuguese authority advises sponsors to:

• submit the transition requests before October 16, 2024, to ensure they are covered by the expedited procedure and to avoid potential scenarios where the continuity of ongoing clinical trials is at stake;
• in line with the guidelines of the Clinical Trials Coordination Group, withdraw all pending substantial amendment requests and, instead, submit the documents related thereto directly in the transition application dossier.

In addition to the above, Infarmed also reminds that, despite this transition periods, sponsors still have the obligation to notify the authority of national and global conclusion of clinical trials approved under the Clinical Trials Directive.

In light of framing the guidelines above, it is worth noting that the Clinical Trials Regulation was initially published on 2014, but it is only applicable since January 31, 2022. This Regulation harmonizes the processes for assessment and supervision of clinical trials throughout the EU, namely by foreseeing that clinical trials’ applications must be submitted through a European centralized platform – the CTIS.

Furthermore, it is also worth highlighting that, in Portugal, the law which implements the Clinical Trials Regulation has not yet been approved or published, despite having already been on legislative circuit. Therefore, at national level and without prejudice to complying with the Clinical Trials Regulation, sponsors of clinical trials must ensure they continue to conform and act in accordance with the Portuguese Clinical Studies Act (Law no. 21/2014, of April 16, in its current wording).