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Amendments to Legislative Decree No 200 of 6 November 2007 implementing Directive 2005/28/EC

On February 14, 2019, the Council of Ministers preliminarily approved the legislative decree amending the text of legislative decree no. 200 of November 6, 2006, implementing Directive 2005/28/EC, for the reorganisation and reform of the legislation on clinical trials on medicinal products for human use, according to the guidelines set out in Article 1, paragraphs 1 and 2 of Law no. 3 of January 11 2018 (Lorenzin Law).

In particular, the decree reorganises the subject matter of clinical trials; it enhances the social and ethical use of research, supporting non-profit research and the creation of new patents starting from pure research; it streamlines the procedures for the use of biological or clinical material remaining from previous diagnostic or therapeutic activities for clinical research purposes and includes gender medicine and the paediatric age among the criteria for clinical trials.

Among the relevant novelties are to be noted the following: the provision of an innovative method of conducting phase I clinical studies that takes into account gender differences and age groups (Article 1, paragraph 1, letter s-bis); the updating of the rates of services still to be charged, through a ministerial decree to be adopted by the end of October 2019, including the tariff facilitation for inspections of good clinical practice on phase I studies in dedicated centers (Article 26, paragraph 3-bis); simplified procedures for the re-use of biological material for clinical research purposes, prepared on the basis of guidelines adopted by the ISS with the support of the BBMRI (article 3, paragraph 13-bis); the provision of specific professional figures, competent in the field of data management and research coordination, which the centers will have to rely on in the use of information systems to support clinical trials (article 21-bis); the obligation for the promoter of observational clinical trials and non-profit clinical studies to reimburse all expenses (direct and indirect) related to the trial, as well as any loss of income related to the non-profit nature of the study (Article 31, paragraph 1-bis); the updating of the decree of 17 December 2004 on non-profit studies, through a ministerial decree to be issued by the end of October 2019, in order to introduce criteria for the identification of non-profit studies and the methods of coordination between public and private promoters within the same study, and to regulate the procedures for the transfer of trial data to the promoter and their use for registration purposes (Article 32, paragraph 1-ter).

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