Health Canada’s HPFB is the national authority that regulates, evaluates and monitors the safety, efficacy, and quality of therapeutic and diagnostic products available to Canadians.
What is Canada’s version of FDA?
Health Canada is the federal body that regulates the drug approval process under the Food and Drugs Act (FDA) and its regulations (FDR), its related policies and guidance.
What agency is responsible for the approval of drugs?
The U.S. Food and Drug Administration (FDA) is the federal agency responsible for labeling medications and supplements. However, the approval process is different for prescription and for over-the-counter medications.
Does FDA regulate Canada?
All health and safety standards under the Food and Drug Regulations are enforced by the Canadian Food Inspection Agency. The Agency is also responsible for the administration of non-health and safety regulations concerning food packaging, labelling and advertising.
Does Canada have a drug agency?
Health Canada plays an active role in ensuring that you have access to safe and effective drugs and health products. The Department strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products. Our highest priority in determining the balance is public safety.
WHO approves new drugs in Canada?
Health Canada is responsible for authorizing the sale and use of new drugs in Canada. It takes 2 to 4 years for Health Canada to review drug safety and efficacy information from clinical trials before deciding to approve (or reject) the use of a new medication.
Who regulates OTC drugs in Canada?
Health Canada is the federal body that regulates the drug approval process (see Question 1). Health Canada is the department of the government responsible for national public health, including ensuring that Canadians have access to safe and effective medical products, including drugs.
What are drugs regulatory agencies?
Regulatory authority and organizations are responsible in effective drug regulation required to ensure the safety, efficacy and quality of drugs, as well as the accuracy and appropriateness of the drug information available to the public.
What government agencies enforce the control of the quality of pharmaceutical products?
9711 otherwise known as “The Food and Drug Administration Act of 2009”, is mandated to ensure the safety, efficacy or quality of health products which include food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents, radiation-emitting devices or equipment, and household/urban hazardous …
Which of the following are valid regulatory agencies?
USFDA(USA), MHRA(UK), TGA(Australia), CDSCO(India), HEALTH CANADA(CANADA), MCC(South Africa),ANVISA (Brazil) , EMEA (European Union), SFDA (China),NAFDAC(Nigeria), MEDSAFE(Newzeland), MHLW(Japan), MCAZ(Zimbabwe), SWISSMEDIC(Switzerland), KFDA(Korea), MoH (Sri Lanka) are the few regulatory agencies and organizations …
Is Pfizer approved in Canada?
The Pfizer-BioNTech COVID-19 vaccine was authorized for use in Canada under the Interim Order respecting the importation, sale and advertising of drugs for use in relation to COVID-19.
What is the difference between FDA and Health Canada?
Health Canada’s Health Products and Food Branch has a mandate of “minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products”. … The FDA’s mandate is “protecting the public health by assuring that…