The Health Products and Food Branch (HPFB) of
Health Canada manages the health-related risks and benefits of health products and food by minimizing risk factors while maximizing the safety provided by the regulatory system and providing information to Canadians so they can make healthy, informed decisions about their health.
HPFB has ten operational Directorates with direct regulatory responsibilities:
* Biologics and Genetic Therapies Directorate
* Food Directorate
*
Marketed Health Products Directorate The Marketed Health Products Directorate (MHPD) is the Canadian federal authority that monitors the safety and effectiveness of health products marketed in Canada. These include:
* Prescription and non-prescription medications
* Biologic medical pro ...
(with responsibility for
post-market surveillance)
* Medical Devices Directorate
*
Natural Health Products Directorate
* Office of Nutrition Policy and Promotion
*
Pharmaceutical Drugs Directorate
* Policy, Planning and International Affairs Directorate
* Resource Management and Operations Directorate
*
Veterinary Drugs Directorate
Extraordinary Use New Drugs
Extraordinary Use New Drugs (EUNDs) is a regulatory programme under which, in times of emergency, drugs can be granted regulatory approval under the ''
Food and Drug Act'' and its regulations.
An EUND approved through this pathway can only be sold to federal, provincial, territorial and municipal governments.
[ The text of the EUNDs regulations is available.][ amendments were made to the Food and Drug Regulations (FDR) to include a specific regulatory pathway for EUNDs. Typically, clinical trials in human subjects are conducted and the results are provided as part of the clinical information package of a New Drug Submission (NDS) to Health Canada, the federal authority that reviews the safety and efficacy of human drugs.][
Health Canada recognizes that there are circumstances in which sponsors cannot reasonably provide substantial evidence demonstrating the safety and efficacy of a therapeutic product for NDS as there are logistical or ethical challenges in conducting the appropriate human clinical trials. The EUND pathway was developed to allow a mechanism for authorization of these drugs based on non-clinical and limited clinical information. A manufacturer of a new drug may file an extraordinary use new drug submission for the new drug if, under paragraph C.08.002.01(1):][
]
International agreements
The HPFB signed an electronic data interchange agreement with the US Food and Drug Administration
The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...
in November 2003, and again in April 2004 with the Therapeutic Goods Administration
The Therapeutic Goods Administration (TGA) is the medicine and therapeutic regulatory agency of the Australian Government. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, p ...
of Australia. Dr Joel Lexchin found the secrecy arrangements in the Memorandum of Understanding to be troublesome and said that "that just makes it more difficult for the medical community to know how drugs were approved, how the data were assessed, and even what data were assessed."
See also
* List of food safety organisations
This is a list of organizations and associated posts which are related to food safety, either as a primary interest or through statutory responsibility. National organizations are grouped by the United Nations geoscheme, UN geoscheme.
Africa
* ...
* Regulation of therapeutic goods
The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are reg ...
References
External links
Health Products & Food Branch
Health Canada
*
Food safety
Product testing
Drug control law
Drug safety
Life sciences industry
Pharmaceuticals policy
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