Therapeutic Products Directorate
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.
Medication
A pharmaceutical drug, also referred to as medicine, medication or medicament, can be loosely defined as any chemical substance intended for use in the medical diagnosis, cure, treatment, or prevention of disease.- Classification :...
and medical devices for human use, a role performed by the Food and Drug Administration
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
in the United States
United States
The United States of America is a federal constitutional republic comprising fifty states and a federal district...
. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy
Efficacy
Efficacy is the capacity to produce an effect. It has different specific meanings in different fields. In medicine, it is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.- Healthcare :...
, and quality as required by the Food and Drugs Act
Food and Drugs Act
Food and Drugs Act is an Act of the Parliament of Canada regarding the production, import, export, transport across provinces and sale of food, drugs, contraceptive devices and cosmetics...
and Regulations.
See also
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
- Good Manufacturing PracticeGood Manufacturing Practice"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...
- Good clinical practiceGood clinical practiceGood Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
- Informed consentInformed consentInformed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...
- Institutional review boardInstitutional review boardAn institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- Investigational productInvestigational productAn investigational product is a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled in a way different from the approved form, or when used for an unapproved...
- Investigator's BrochureInvestigator's brochureIn drug development, the Investigator's Brochure is a comprehensive document summarizing the body of information about an investigational product obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new information...