National Differences in Requirements for Ethical and Competent Authority Approval for a Multinational Vaccine Trial under the EU Directive 2001/20/EC.
Obtaining approval for a multinational vaccine trial from an ethics committee and the national competent authority of different Member States of the European Union (EU) is challenging under clinical trial Directive 2001/20/EC because of the differences in the implementation of the directive in national laws of Member States. In this review the national differences in requirements for ethical and competent authority approval are illustrated. The national ethical and competent authority review procedures in Finland, Hungary, The Netherlands, Norway and Slovenia are described under the EU trial directive after discussing the provisions of the trial directive related to both review procedures. The review illustrates the differences between the countries in the documents that have to be submitted for the review procedures, the submission procedures and the language requirements of the documents, the organization of the ethics committees and the role of the competent authority in the approval procedure.
Unit of PharmacoEpidemiology and PharmacoEconomics, Department of Pharmacy, University of Groningen, 9713 AV Groningen, The Netherlands. e.van.doorn@rug.nl.
Eva
E
van Doorn
Unit of PharmacoEpidemiology and PharmacoEconomics, Department of Pharmacy, University of Groningen, 9713 AV Groningen, The Netherlands. e.hak@rug.nl.
Eelko
E
Hak
Unit of Pharmacotherapy and Pharmaceutical Care, Department of Pharmacy, University of Groningen, 9713 AV Groningen, The Netherlands. b.wilffert@rug.nl.|Department of Clinical Pharmacy and Pharmacology, University Groningen, University Medical Center Groningen, 9700 RB Groningen, The Netherlands. b.wilffert@rug.nl.
Bob
B
Wilffert
approval documentation; clinical trial; directive 2001/20/EC; vaccine