In all cases applications of gene therapy clinical protocols fall under the scope of the Belgian Biosafety regulation on contained use of GMO’s. 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 can/must also be applied.
As far as biosafety regulation is concerned, whatever the legal basis and the competent authority could be, proposals of gene therapy clinical protocols or clinical protocols with a medicinal product involving a genetically modified organism are reviewed by the ad hoc Expert group "Recombinant viral vectors, virosomes, recombinant vaccines, gene therapy" of the Belgian Biosafety Advisory Council (BAC) or directly by the experts of the Division of Biosafety and Biotechnology (SBB) as a function of the regulatory framework and of the degree of familiarity of the Biosafety Council with the proposed project.
A detailed description of the application procedures is given on the Belgium Biosafety Server in:
- Regulatory framework for gene therapy clinical trials or clinical trials with a medicinal product involving a genetically modified organism in Belgium.;
- Current procedural aspects for the authorisation of gene therapy clinical trials in Belgium.
(Last reviewed by the Competent Authority: 5 May 2010)