The Concept of a Clinical Trial In the Serbian Law and in the European Union Law Cover Image

The Concept of a Clinical Trial In the Serbian Law and in the European Union Law

Author(s): Nina Planojević
Subject(s): Health and medicine and law, EU-Legislation
Published by: Правни факултет Универзитета у Нишу
Keywords: medical law; clinical trials; EU law; Directive 2001/20/ЕС

Summary/Abstract: Clinical trials on medicines are a preliminary and inevitable stage of clinical research aimed at ensuring a safe application of medicinal products in the future. There is not dispute that the progress of medicine and the survival of manking largly depend on clinical trials, which are an important part of clinical research. The subject matter of this paper is the definition of clinical trials in the Serbian legislation as well as in the EU law, i.e. in the Directive 2001/20/ЕС. In the first part of the paper, the author identifies and analyzes elements consituting the notion of clinical trial, including the subjects (participants) in clinical trial, the objectives of clinical trial and the subject matter of clinical research. In the second part of the paper, the author points out to the distinction between clinical trials and some similar concepts: medical experiments and medical research. In the final part of the paper, after comparing the definitions on clinical trial as provided in the Serbian legislation and in the European Union law, the author draws a conclusion that the Serbian legal provisions fully comply with the EU provisions on this matter.

  • Issue Year: LIII/2014
  • Issue No: 68
  • Page Range: 371-388
  • Page Count: 18
  • Language: Serbian