Italy opens the way to commercial use of data obtained by non-profit clinical trials

On May 8th, 2019, the Italian government approved the text of a legislative decree on clinical trials introducing changes to several provisions of the existing national regulation on clinical trials (the "Amending Act"). The Amending Act shall come into force 15 days as of the date of publication in the Italian Official Journal (yet to occur).

Some of the changes are introduced for coordination with the Regulation (EU) no. 536/2014 on clinical trials. Other amendments are intended to improve specific aspects of the regulation (e.g. among many others, new provisions should be issued in order to allow the use in the clinical research of biologic materials remaining from diagnostic or therapeutic activities; and also new regulation is to be issued to promote gender medicine and paediatric trials). One of the most interesting changes is concerned with the regulation of non-profit clinical trials. This Newsflash will focus on the new provisions regarding non-profit trials.

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