Submit an Article > Register > Login >

Annali

dell'Istituto Superiore di Sanità

Search
Vol. 50 No. 4 (2014)
Original Articles
2014-12-15

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

Authors

Carlo Petrini

Keywords: Europe, human experimentation, legislation

Abstract

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 over-view of the general aspects of the new procedures. It does not address the specific issues involved, each of which merits separate examination.
Share on

Downloads

PDF
Authors

Carlo Petrini

License

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.

How to Cite
Petrini, C. (2014). Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use: an overview. Annali dell’Istituto Superiore Di Sanità, 50(4), 317–321. Retrieved from https://annali.iss.it/index.php/anna/article/view/88
  • Abstract viewed - 343 times