All ongoing clinical trials in the EU must be transferred to the Clinical Trials Information System (CTIS) by 31 January 2025. This date marks the end of a three-year transition period, which began with the entry into force of Regulation no. 536/2014 on clinical trials (CTR) in the EU and marks the definitive transition to the provisions of the Regulation for all ongoing trials.

To help sponsors make the transition, a guide on the best practices and additional support material is available. Dedicated training activities were also organised, starting with an event for the academic world on 9 February.

The European Regulation was therefore created with the aim of creating a favorable environment for carrying out clinical trials in Europe, through the harmonization of the rules and processes for their evaluation and supervision.

The objective is to guarantee high standards for the safety of participants and the transparency of information, thanks to the publication of all information regarding the authorisation, conduct and results of each trial conducted in Europe.

For this reason, a dedicated portal has been developed: the Clinical Trials Information System (CTIS), to strengthen collaboration and exchange of information between and within Member States.

The authorization and supervision of clinical trials will remain aresponsibility of the Member States, while EMA will manage the CTIS and the publication of its contents in the public section of the portal. The European Commission will have the role of supervisor in the implementation of the Clinical Trials Regulation.

On the AIFA website European Clinical Trials Regulations | All useful information and documents are available at the Italian Medicines Agency (aifa.gov.it).

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