Therapeutic Products Directorate
Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices 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 seven 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
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