DefinitionInNationalLaw object
The existing law in Belgium for clinical trials, Law 7 May 2004 (Law concerning experiments on the human person) is transposed from the EU Directive 2001/20.
Scope of law: Experiments (including clinical trials) apply to drugs, medical devices & non-drug experiments, all experiments on human beings, commercial as well as non-commercial, interventional as well as non-interventional. “Interventional” has a broad sense: prospective questionnaires, additional blood sampling, supplementary visits,.. are considered as interventional (anything outside normal clinical practice).
Not in scope of law: Data collection only, retrospective data analysis (epidemiologic, cost),..
“clinical trial": any investigation in human persons intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of one or more investigational medicinal product(s), and/or to identify any adverse reactions to one or more investigational medicinal product(s) and/or to study absorption, distribution, metabolism and excretion of one or more investigational medicinal product(s) with the object of ascertaining its (their) safety and/or efficacy.