Therapeutic Products Directorate
From Wikipedia, the free encyclopedia
Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. 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.
[edit] 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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