The hurdles of conducting clinical trials across different countries: focus on new European regulations

 

Authors

  • G. Mittica Medical Oncology-1, University of Turin Medical School, Fondazione del Piemonte per l’Oncologia - Candiolo Cancer Institute (IRCCS), Candiolo (Turin), Italy.
  • J. Pfisterer Gynecologic Oncology Center, AGO Study Group, Kiel, Germany.

Keywords:

clinical trials, European Union, regulations

Abstract

The new European Union (EU) regulation governing clinical trials and medicinal products became effective on June 16th, 2014 but full implementation is scheduled for May 2016 onwards. The repeal of the Clinical trial directive 2001/20/EC is welcomed because the old directive was a highly criticized piece of pharmaceuticalrelated legislation. The new legislation is binding and must be applied in all EU-28 member states, and will hopefully simplify and speed up clinical trial applications and authorizations. This article describes key innovations in the new legislation.

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Published

2015-11-15

How to Cite

1.
Mittica G, Pfisterer J. The hurdles of conducting clinical trials across different countries: focus on new European regulations:  . CBN [Internet]. 2015 Nov. 15 [cited 2024 Nov. 21];3(2):44-6. Available from: https://journals.aboutscience.eu/index.php/cancerbreakingnews/article/view/244

Issue

Vol. 3 No. 2 (2015): November 2015

Section

Methodological corner

License

Articles published in Cancer Breaking News are distributed under the CC Attribution-NonCommercial-NoDerivatives 4.0 license, which allows third parties to copy and redistribute the material providing appropriate credit and a link to the license but does not allow to use the material for commercial purposes and to use the material if it has been remixed, transformed or built upon.