The Federal Public Service Health, Food Chain Security and Environment, General direction Animals, Plants and Food, Division Medicinal products (DGMP) is the competent authority for clinical gene therapy trials. Applications of gene therapy clinical protocols are submitted to the Directorate-General Public Health Protection: Medicinal Products and is also sent to the Division of Biosafety and Biotechnology (SBB) and the concerned regional Ministers. The application is reviewed by an ad hoc expert group of the Belgian Biosafety Advisory Council (BAC) or directly by the experts of the SBB, which transmits its advice to the competent authority (DGMP) and the regional ministers. Based on the BAC recommendations, the recommendations of the regional ministers and the public consultation, the DGMP submits a decision proposal to the Minister of Public Health for final decision.

A detailed description of the application procedures is given in:
- Current procedural aspects for the authorisation of gene therapy clinical trials in Belgium;
- Regulatory framework for gene therapy clinical trials or clinical trials with a medicinal product involving a genetically modified organism in Belgium.

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