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Regulatory framework for gene therapy
clinical trials or clinical trials with a medicinal product involving a genetically modified organism in Belgium
(Authors: M. Sneyers and M. Goossens - Last revised:
May 5, 2010
)
1. As all clinical trials, clinical research in gene therapy using genetically modified organisms (GMO's) and/or pathogen organisms falls under the scope of the Belgian law of 7 mai 2004 (available as PDF file in dutch and french) on experimentation on human beings implementing Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use (available as PDF file in english - in dutch - in french).
More details about the Belgian law and its implementation decisions as well as about procedures and application content are available on the web site of the Federal Agency for Medicines and Health Products - chapter clinical trials
2. Clinical research in gene therapy using genetically modified organisms (GMO's) and/or pathogen organisms falls under the scope of Belgian biosafety regulation. In all cases, an authorisation must be obtained according to the Belgian regulations on contained use of GMO's and/or pathogen organisms which implement Directive 2009/41/EC repealing Directives 90/219/EEC and 98/81/EC. In the case of multicentre trials and/or for those trials that involve ambulatory medicine and the risk of excretion of GMO's by the patient into the environment, the Belgian regulation on the deliberate release of GMO's which implements Directive 2001/18/EC can/must also be applied.
Current procedural aspects and application content
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