European Clinical Trials Regulation 536/2014: concerns and perspectives of a Member State

The European Regulation 536/2014, entered into force on June 16, 2014 and not effective for several years for a delay in the development of a fully functional European portal, has represented a turning point in the legislation regarding clinical trials on medicinal products. Unlike other countries, Italy was unable to translate the multitude of decrees regulating clinical trials in one legislative act.
The first step towards the alignment with Regulation 536/2014 was the Law 3/2018 that recognized the necessary changes that had to be made, the simplification of the submission and evaluation process by the Ethics Committees, the importance of infrastructure and support personnel in the conduct of clinical trials, among others.
So far only three implementing decrees have been circulated one introducing the Coordination Center of Territorial Ethics Committees (CNCCE), one establishing two national ECs and a decree regarding observational and no profit studies.
Certainly, further legislative measures will be needed to complete the implementation framework. There is a great deal of expectation with respect to the measure that will define the minimum requirements of clinical centers authorized for the conduct of clinical trials, as well as any other decrees necessary to address the critical issues described above.


The paper provides an overview of the actions taken in a Member State to implement the European Regulation, some of which took a long time and continue to present multiple criticalities.


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Table of Content: Vol. 2 (No. 3) 2022 September

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