Clinical Trials in Belgium

Belgium is one of the first European Member States where the implementing regulation of the Clinical Trials Directive is fully operational. The specific conditions provided for in the new law concerning experiments on the human person reinforce Belgium as a very attractive host for clinical trials, ensuring a lasting environment for innovative research. This Operational Guidance clarifies the practical implications of the new regulations. It analyses the new Belgian law from the perspective of the sponsor of a clinical trial, but addresses the roles and tasks of all parties involved in clinical trials. In order to assist everyone involved in clinical trials in the practical implementation of the new law, the Guidance provides for a short and comprehensive overview and insight into the process flows of the submission to and evaluation by the competent authority and the ethics committee of a clinical trials application. In addition, standard templates for the most important documents are added.