Clinical trials in Italy, the latest news

by Margherita Barletta

As of January 31, 2023, all initial clinical trial applications in the European Union must be submitted through the Clinical Trials Information System (CTIS), the single point of access for sponsors and clinical trial regulators to submit and evaluate clinical trial data.

With the CTIS, sponsors can now apply for authorizations in up to 30 EU countries, at the same time and with the same documentation. There is a transition period that will last until January 31, 2025, when all ongoing trials will be governed by the new regulation and transferred to the CTIS.

But the novelties do not end there as at the end of January 2023 the Minister of Health signed four decrees that will bring significant improvements to clinical trials in Italy.

With the signing of the four decrees concerning Ethics Committees, a decisive step, long overdue for years, is being taken toward the full implementation of the European Regulation 536/2014 on clinical trials in our system.

More specifically, with the Decree of the Minister of Health of January 26, 2023, and after agreement at the State-Regions Conference, the 40 territorial Ethics Committees that have the task of evaluating clinical trials on medical devices and medicines for human use were identified. This was the result of the virtuous synergy developed between the Ministry, AIFA, Regions, and autonomous Provinces.

A Decree of the Minister of Health on January 27, 2023, also regulated the transitional phase in relation to the evaluation activities and the modalities of interaction between the Coordination Center, territorial Ethics Committees, Ethics Committees of national significance, and the Italian Drug Agency.

Another important measure that has been long awaited, and decisive in the perspective of administrative streamlining, is the decree, adopted by the Minister of Health in consultation with the Minister of Economy and Finance, determining the single tariff for clinical trials.

Also signed was the decree of regulatory harmonization. It regulates the functions of the Ethics Committees, the criteria for the division of responsibilities between territorial Ethics Committees and Ethics Committees of national importance, and the criteria for the composition of Ethics Committees, in order to ensure that the members have documented knowledge and experience in clinical trials of medicines and medical devices and to guarantee their independence.

These are measures of fundamental importance for the regulatory process of approval of trials. They are the result of a shared effort with the regions and administrations involved, which will result in improving Italy's performance in the sector and moving in the direction of less bureaucracy without renouncing that level of scientific rigor that is essential to ensure safe drugs and medical devices and overall development of the system and the industrial fabric of reference.

In fact, as early as last May, the National Coordination Center of Ethics Committees in a circular dated May 30, 2022, adopted new contract schemes for clinical trials on drugs and clinical investigations on devices.

These updates, which are part of a broader process of standardization of regulations in EU member states, could be a driver for investment by overseas sponsors, who have been deterred so far by excessive bureaucracy and lack of homogeneity in procedures.

Contact information

Margherita Barletta

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