Important Updates Regarding Clinical Trial Agreements in Italy

As is well known, Regulation (EU) No. 536/2014 (the “Regulation”) became fully applicable on 31 January 2022. From that date, a one-year transitional period began, during which applications for authorisation of clinical trials under the previous regulatory framework could still be submitted on a voluntary basis. After the end of this transitional period, this possibility, as well as the related national regulations, will no longer apply. In fact, within the next three years all ongoing clinical trials will transition to the new requirements established by the EU Clinical Trials Regulation (CTR).

In order to increase transparency regarding clinical trial information, a dedicated portal for the management of all clinical trials in Europe has been developed: the Clinical Trials Information System (CTIS). This platform will play a key role in promoting transparency and strengthening cooperation, information sharing and decision-making processes both among and within Member States.

By means of a circular dated 30 May 2022, the National Coordination Centre for Ethics Committees adopted new model agreements for clinical trials on medicinal products and clinical investigations involving medical devices, available for download at the following website:

https://www.aifa.gov.it/en/centro-coordinamento-comitati-etici

The Coordination Centre adopted the following model agreements:

• Agreement for the conduct of clinical trials on medicinal products;
• Agreement for the conduct of independent clinical trials on medicinal products;
• Agreement for the conduct of clinical investigations on medical devices that are either not CE-marked or CE-marked but used outside their intended purpose.

The Agreement for the Conduct of Clinical Trials on Medicinal Products has been updated to align with the provisions of the Regulation.

The Agreement for the Conduct of Independent Clinical Trials on Medicinal Products was adopted for the first time following the publication of the Ministerial Decree of 30 November 2021.

The Agreement for the Conduct of Clinical Investigations on Medical Devices that are not CE-marked or are CE-marked but used outside their intended purpose has been completely revised compared to the version adopted on 25 September 2020, particularly in light of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.

These updates, which form part of a broader process of regulatory harmonisation among Member States, may encourage investment by overseas sponsors who, until now and prior to these recent legislative changes, have often been discouraged by bureaucracy and the lack of procedural uniformity.

For further information, please contact Paula Vega at p.vega@bmvinternational.com.

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