Typical investigational medicinal products follow relatively uniform regulations in 10 European Clinical Research Infrastructures Network (ECRIN) countries

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • Christian Gluud - , University of Copenhagen (Author)
  • Christine Kubiak - , INSERM - Institut national de la santé et de la recherche médicale (Author)
  • Kate Whitfield - , University of Copenhagen (Author)
  • Jane Byrne - , Manchester University NHS Foundation Trust (Author)
  • Karl Heinz Huemer - , Medical University of Vienna (Author)
  • Steffen Thirstrup - , Danish Medicines Agency (Author)
  • Christian Libersa - , INSERM - Institut national de la santé et de la recherche médicale (Author)
  • Béatrice Barraud - , INSERM - Institut national de la santé et de la recherche médicale (Author)
  • Xina Grählert - , Administrative Units of the Faculty of Medicine, Coordination Centre for Clinical Studies Dresden (KKS-DD) (Author)
  • Gabriele Dreier - , University of Freiburg (Author)
  • Sebastian Geismann - , University of Freiburg (Author)
  • Wolfgang Kuchinke - , Heinrich Heine University Düsseldorf (Author)
  • Zsuza Temesvari - , Hungarian ECRIN Committee (Author)
  • Gyorgy Blasko - , Hungarian ECRIN Committee (Author)
  • Gabriella Kardos - , Hungarian ECRIN Committee (Author)
  • Timothy O'Brien - , University of Galway (Author)
  • Margaret Cooney - , Irish Clinical Research Infrastructures Network (ICRIN) (Author)
  • Siobhan Gaynor - , Irish Clinical Research Infrastructures Network (ICRIN) (Author)
  • Arrigo Schieppati - , IRCCS Istituto di ricerche farmacologiche Mario Negri - Milano, Bergamo, Ranica (Author)
  • Fernando de Andres - , Complutense University (Author)
  • Nuria Sanz - , University of Barcelona (Author)
  • German Kreis - , University of Barcelona (Author)
  • Charlotte Asker-Hagelberg - , Karolinska Institutet (Author)
  • Hanna Johansson - , Karolinska Institutet (Author)
  • Sue Bourne - , UK Clinical Research Collaboration (Author)
  • Adeeba Asghar - , NIHR Clinical Research Network (CRN) (Author)
  • Jean Marc Husson - , European Forum for Good Clinical Practice (Author)
  • Jacques Demotes-Mainard - , INSERM - Institut national de la santé et de la recherche médicale (Author)

Abstract

Background: In order to facilitate multinational clinical research, regulatory requirements need to become international and harmonised. The EU introduced the Directive 2001/20/EC in 2004, regulating investigational medicinal products in Europe.Methods: We conducted a survey in order to identify the national regulatory requirements for major categories of clinical research in ten European Clinical Research Infrastructures Network (ECRIN) countries-Austria, Denmark, France, Germany, Hungary, Ireland, Italy, Spain, Sweden, and United Kingdom-covering approximately 70% of the EU population. Here we describe the results for regulatory requirements for typical investigational medicinal products, in the ten countries.Results: Our results show that the ten countries have fairly harmonised definitions of typical investigational medicinal products. Clinical trials assessing typical investigational medicinal products require authorisation from a national competent authority in each of the countries surveyed. The opinion of the competent authorities is communicated to the trial sponsor within the same timelines, i.e., no more than 60 days, in all ten countries. The authority to which the application has to be sent to in the different countries is not fully harmonised.Conclusion: The Directive 2001/20/EC defined the term 'investigational medicinal product' and all regulatory requirements described therein are applicable to investigational medicinal products. Our survey showed, however, that those requirements had been adopted in ten European countries, not for investigational medicinal products overall, but rather a narrower category which we term 'typical' investigational medicinal products. The result is partial EU harmonisation of requirements and a relatively navigable landscape for the sponsor regarding typical investigational medicinal products.

Details

Original languageEnglish
Article number27
JournalTrials
Volume13
Publication statusPublished - 27 Mar 2012
Peer-reviewedYes

External IDs

PubMed 22452964

Keywords