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Latest revision as of 14:32, 12 March 2016
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.[1] 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
References
- ^ "Pharmaceutical Drugs Directorate". Government of Canada. May 2, 2022. Archived from the original on December 5, 2023. Retrieved February 24, 2024.
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Notes
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