Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use: an overview

• Main Author: Carlo Petrini
• Format: Article
• Language: English
• Published: Istituto Superiore di Sanità 2014-12-01
• Series: Annali dell'Istituto Superiore di Sanità
• Subjects: Europe; human experimentation; legislation
• Online Access: http://www.scielosp.org/scielo.php?script=sci_arttext&pid=S0021-25712014000400004&lng=en&tlng=en

For the 28 member states of the European Union, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use, which repeals Directive 2001/20/EC, represents a substantial innovation in the procedures for authorising clinical trials and for handling all the subsequent stages. It introduces a single authorisation that will be valid for all EU member states, as well as a single portal through which all data concerning all clinical trials performed throughout the EU will pass. The present article offers an overview of the general aspects of the new procedures. It does not address the specific issues involved, each of which merits separate examination.