In the Official Gazette of 14 June 2023, the Decree of the Ministry of Health of 20 March 2023 regulating the requirements of facilities suitable for conducting clinical investigations and the Decree of the Ministry of Health of 20 March 2023 introducing provisions to ensure that persons in charge of evaluating and validating clinical investigation applications do not have a conflict of interest, are independent of the sponsor, the investigators involved and the natural or legal persons financing the clinical investigation, and are free from any undue influence were published. These decrees, which are immediately applicable, are provided for in article 16, paragraphs 5 and 8 of Legislative Decree No. 137/2022.
The first decree provides that, in order to ensure health protection, clinical investigations must be carried out in facilities characterized by documented expertise in controlled clinical trials, and which make consolidated use of medical devices belonging to the same type and class as those under clinical investigation. In addition to this, the assessment of the facility’s suitability for conducting clinical investigations must be attested by a statement provided by the facility’s legal representative.
The second decree, on the other hand, provides that the Ministry of Health shall identify the persons in charge of evaluating and validating clinical investigation applications. In addition to this, the decree provides that those appointed must possess proven scientific and professional qualifications, must not be subject to any influence that could affect their assessment, and must perform their work independently, transparently, impartially, and without conflict of interest.