Investigational Medicinal Product Dossier

Clinical Trial Authorization (CTA) is mandatory to conduct clinical trials in humans. CTA can only be obtained after submission of a group of scientific documents in the form of Investigational Medicinal Product Dossier (IMPD). EU Clinical Trials Directive 2001/20/EC defines “investigational medicinal product” (IMP) as, “A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form”.
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