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Vol.16 Issue 1 (2020)

Drug Clinical Trials Legislation
In The European Union

Paola Sangiovanni, Flavio Monfrini and Marco Bertucci

The purpose of this article is to illustrate the basic tenets of European Union law on clinical trials. Such body of law has been progressively harmonized in the European Union over the years with the aim of subjecting interventional clinical trials conducted in any of the 27 European Union Member States to identical rules.
The article initially describes the reasons why clinical trials are important to measure the safety, efficacy and cost-effectiveness of innovative medical treatment. It then continues by illustrating the scope and basic principles of the current EU Regulation, as well as its main changes over the previous legislation. Further, the article explains the requirements of the scientific and the ethical approvals of a clinical trial application. Lastly, the authors focus on the patients’ consent to the enrolment in a clinical trial, as well as to the patients’ separate consent to the processing of their personal data.


The authors are Partners, Gitti and Partners, with an expertise in commercial and cor-
porate law and regulatory matters.

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