Therapeutic Products Directorate

Pharmaceutical Drugs Directorate (PDD) 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