Pharma Regulation in Canada
Health Canada is responsible for establishing that consumers have access to safe drugs and health products. The department works to evaluate drugs for their potential benefits and risks and strives to find a healthy balance between the two. Their main priority is to ensure that medications are safe for consumers. The department works with a variety of other professionals and groups such as the government, health care professionals, the research community, manufacturers and consumer interest groups in order to maximize the safety of medications on the market and to ensure that there is pharmaceutical compliance across the board. The department also strives to provide information to consumers in order to allow them to make informed decisions about their health. In order to ensure their unbiased services, Health Canada does not manufacture or distribute pharmaceutical products. They are simply the federal regulator.
Regulating Pharmaceutical Products in Canada
Every day there are many Canadians who use pharmaceutical products that have already received approval by Health Canada. Many pharmaceutical products are used to treat or prevent a wide variety of diseases or various disabling physical conditions. In order to maintain the health of Canadians, Health Canada ensures that the products they use for health reasons are safe as well as effective. Pharmaceutical products are regulated in Canada through the Foods and Drugs Act which is overseen by Health Canada. This department uses their own definition of pharmaceutical drugs which includes synthetic products which are made from chemicals including:
· Both non-prescription and prescription drugs
· Disinfectants
· Health related products such as antiperspirants or sunscreen
There are approximately 13,000 drugs presently on the market just in Canada, many of these are critical to the health care of many individuals.
Canada’s Food and Drugs Act
Health Canada is a federal regulator and is the agency or department that is responsible for monitoring and assessing the wide variety of drugs marketed in Canada. They assess and monitor drugs to ensure that they are in pharmaceutical compliance with the Food and Drugs Act along with its accompanying regulations. There are many different regulatory activities which are specifically designed to evaluate and monitor drugs for safety, efficacy and quality both before and after they hit the market. This type of activity can be a very expensive proposition and it is funded in part by the industry. The department also carries responsibility of the remaining costs associated with reviewing the applications for clinical trials, enforcement and compliance for the clinical trials. The program costs approximately $80 million. Health Canada carries the cost for direct programs and employees to enforce the regulations. The pharmaceutical industry also helps provide funds for the department.
What is Health Canada responsible for?
Health Canada is similar in organization to the US’ Food and Drug Administration when it comes to approving drugs for release on the market. However, they do not have as much authority after the drugs have been released. For example, they cannot require industries to make label changes which reflect new safety information which may become available. The basic responsibilities of Health Canada include:
· Thoroughly reviewing the applications for clinical trials which are going to be conducted in Canada
· Carefully reviewing drug submissions presented by manufacturers who need market authorization and any post market release changes
· Monitoring drugs for safety in Canada and communicating safety risks to the public and health care professionals while collaborating with the industry
· Enforcing pharmaceutical compliance across the industry including the full life of the drug from clinical trials, drug manufacturers, and reporting of any adverse reactions caused by the drugs
Mission Statement by Health Canada
Health Canada states that they play an active role in ensuring that the Canadian public has access to drugs and health products which are both safe and effective. The department strives to make health related information available to the public and also works closely with a wide variety of health industry professionals. It is the goal of Health Canada to minimize health risk factors while maximizing safety for consumers. They are intent on maintaining communication with consumes so that they remain up to date on all of the latest developments which pertain to drugs in Canada.
Regulating Pharmaceutical Products in Canada
Every day there are many Canadians who use pharmaceutical products that have already received approval by Health Canada. Many pharmaceutical products are used to treat or prevent a wide variety of diseases or various disabling physical conditions. In order to maintain the health of Canadians, Health Canada ensures that the products they use for health reasons are safe as well as effective. Pharmaceutical products are regulated in Canada through the Foods and Drugs Act which is overseen by Health Canada. This department uses their own definition of pharmaceutical drugs which includes synthetic products which are made from chemicals including:
· Both non-prescription and prescription drugs
· Disinfectants
· Health related products such as antiperspirants or sunscreen
There are approximately 13,000 drugs presently on the market just in Canada, many of these are critical to the health care of many individuals.
Canada’s Food and Drugs Act
Health Canada is a federal regulator and is the agency or department that is responsible for monitoring and assessing the wide variety of drugs marketed in Canada. They assess and monitor drugs to ensure that they are in pharmaceutical compliance with the Food and Drugs Act along with its accompanying regulations. There are many different regulatory activities which are specifically designed to evaluate and monitor drugs for safety, efficacy and quality both before and after they hit the market. This type of activity can be a very expensive proposition and it is funded in part by the industry. The department also carries responsibility of the remaining costs associated with reviewing the applications for clinical trials, enforcement and compliance for the clinical trials. The program costs approximately $80 million. Health Canada carries the cost for direct programs and employees to enforce the regulations. The pharmaceutical industry also helps provide funds for the department.
What is Health Canada responsible for?
Health Canada is similar in organization to the US’ Food and Drug Administration when it comes to approving drugs for release on the market. However, they do not have as much authority after the drugs have been released. For example, they cannot require industries to make label changes which reflect new safety information which may become available. The basic responsibilities of Health Canada include:
· Thoroughly reviewing the applications for clinical trials which are going to be conducted in Canada
· Carefully reviewing drug submissions presented by manufacturers who need market authorization and any post market release changes
· Monitoring drugs for safety in Canada and communicating safety risks to the public and health care professionals while collaborating with the industry
· Enforcing pharmaceutical compliance across the industry including the full life of the drug from clinical trials, drug manufacturers, and reporting of any adverse reactions caused by the drugs
Mission Statement by Health Canada
Health Canada states that they play an active role in ensuring that the Canadian public has access to drugs and health products which are both safe and effective. The department strives to make health related information available to the public and also works closely with a wide variety of health industry professionals. It is the goal of Health Canada to minimize health risk factors while maximizing safety for consumers. They are intent on maintaining communication with consumes so that they remain up to date on all of the latest developments which pertain to drugs in Canada.