IMA approves the conduct of a clinical trial. IMA evaluates the quality of the investigation and investigational medicinal product and the overall safety of participants in clinical trials. Before a clinical trial can be started, approvals have to be obtained from IMA and the National Bioethics Committee. IMA provides scientific advice concerning the development of medicinal products.
A clinical trial is a systematic investigation of a medicinal product intended to gather or confirm knowledge on efficacy, interaction, adverse reaction and pharmacokinetics or investigate its medicinal value.Scientific Advice
Scientific advice is about advising medicine developers on the most appropriate way to generate robust evidence on a medicine’s benefits and risks.