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Italy Reforms Clinical Trial Rules

Marco de Morpurgo


During the past few months, Italy has seen the introduction of important changes to the regulatory framework applicable to clinical trials conducted in the country. On 22 December 2017, the Italian Senate adopted the long-awaited delegation law on clinical trials (‘Delegation Law’), which (among other things) mandates a reform of the Italian regulatory framework with a view to adapting it to the upcoming European Union ('EU') Clinical Trials Regulation. Earlier that month, a ministerial decree regulating the use of investigational medicinal products outside a clinical trial (‘Decree on Compassionate Use’) entered into force. Section I of this report discusses the key elements of the new Delegation Law on clinical trials. Section II briefly reviews the new Decree on Compassionate Use insofar as it concerns investigational medicinal products. Section III concludes by clarifying what are the next steps we should be watching for.

Associate at Allen & Overy LLP; Contract Professor of Law at HEC Paris. For correspondence: <>


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