Abstract
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.
Highlights
Since 2001, the Directive 2001/20/EC of the European Parliament and the European Council has been regulating the implementation of good clinical practice (GCP) in the conduct of clinical trials on medicinal products for human use [1]
The ethics committee that has to give a favorable opinion before a scientific research can be conducted in The Netherlands is according to the “Medical Research Involving Human Subjects Act” (in Dutch known as “Wet medisch-wetenschappelijk onderzoek met mensen” (WMO)), an accredited medical research committee (MREC) or the Central Commission Research Involving Human Subjects (in Dutch known as the Centrale Commissie Mensgebonden Onderzoek (CCMO)) [47,48,49,50,51]
Under the European Union (EU) clinical trial Directive 2001/20/EC it is a challenge to obtain ethical approval for a multinational vaccine trial from each Member State of the EU participating in the trial as illustrated by this review due to the differences in the implementation of the directive in the national laws of the Member States
Summary
Since 2001, the Directive 2001/20/EC of the European Parliament and the European Council has been regulating the implementation of good clinical practice (GCP) in the conduct of clinical trials on medicinal products for human use [1] The aim of this directive is to harmonize the national procedures for the ethical approval of clinical trials in Member States of the European Union (EU) [1,2]. On 14 April 2014, the European Council approved a draft regulation on clinical trials on medicinal products for human use and for the repealing of Directive 2001/20/EC [4,10] This regulation, which is expected to be in effect in 2016 after a start-up period of 2 years, is binding in its entirety and is directly applicable in the Member States [4,5,6,7,10,11].
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
