Clinical Trials Regulation and the Italian alignment


The Clinical Trials Regulation is the new European Union pharmaceutical regulation regarding clinical trials. It entered into force on 31 January 2022 in order to harmonize the processes of submission, evaluation and supervision of clinical trials in Europe.

Legislative innovations regarding clinical trials

The truly innovative aspect of this legislation is the Clinical Trials Information System (CTIS), a single access point for clinical trial sponsors and regulators to submit and evaluate data.

This system consists of a public database that can be consulted by healthcare professionals, patients and the general population, to guarantee the transparency and safety of trials.

The introduction of the legislation makes it possible to reduce administrative burdens for researchers and pharmaceutical companies, guaranteeing coordinated and faster authorization of clinical trials.

Before this regulation, in fact, sponsors had to submit the application for participation separately to the competent national authorities and ethics committees of each country to obtain regulatory approval.

Now, thanks to the CTIS portal, you only need to complete one online application in order to receive approval valid in several European territories. In this way it is hoped to promote innovation and research within the European Union, facilitating the conduct of large clinical trials in multiple countries.

The advantage of having an accessible public database is also that of facilitating the recruitment of patients, who are able to find out about the trials available directly from the platform.

The hope by 2025 is to have an integrated and functioning platform, which is the center of European clinical trials.

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 the processes of evaluation and supervision of the same, guaranteeing at the same time the highest standards for the safety of the participants and the transparency of the information, thanks to the relative publication of all those concerning the authorization, the conduct and the results of each trial conducted in Europe.

In order to align with these parameters, Italy is adopting a reorganization of the system.

Italy’s strategy

The Italian clinical trial is managed, among other actors, by ethics committees. The latter are independent bodies who are responsible for ensuring the protection of people’s rights, safety and well-being during their studies.

The reform consists in reducing the number of territorial ethics committees (CET) from 80 to 40, with appointments through tenders announced by the regions. Just in the last few weeks, the lists of CETs for the evaluation of clinical trial applications from some regions have been published, available on the AIFA website.

Each of them will no longer deal only with clinical trials of drugs, but also “with every question on the use of medicines and medical devices, surgical and clinical procedures and the study of food products on humans”.

In this way, a more streamlined and competent network is created, with operational simplification of clinical trials and optimization of timing, which also allows us to adapt to the regulations of the European Regulation so as not to lose competitiveness in research.

Another big change is that from 31 January 2023 it is no longer possible to submit new requests for authorization for clinical trials via the Italian OsSc platform (National Observatory on Clinical Trials), but only through the European CTIS platform.

This reform is fundamental to ensure that Italy updates itself and becomes on par with other research ecosystems, especially on the technological and regulatory front.

In fact, we must always underline how important clinical research is aimed at developing new drugs, treatment protocols and effective and safe devices to treat pathologies and respond to health needs.

According to an IQVIA survey, between 2020 and 2021 clinical trials increased by 14%, with multibillion-dollar investments. The reorganization of the system is a step forward towards ensuring a major role within research, at a European and not just a more national level.