Pharmaceutical Drugs Directorate (PDD), previously called the Therapeutic Products Directorate (TPD), is a Canadian federal authority that regulates small molecule pharmaceutical drugs for human use. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy, and quality as required by the Food and Drugs Act and Regulations. It is one of the ten operational directorates of the Health Products and Food Branch, a branch of Health Canada.
See also European Medicines Agency Good Manufacturing Practice Good clinical practice Informed consent Institutional review board International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Investigational product Investigator's Brochure
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