Understanding How Canada Drugs are Regulated

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Understanding How Canada Drugs are Regulated

Posted On : Feb-22-2011 | seen (1367) times | Article Word Count : 598 |

The pharmaceutical companies that manufactured Canada drugs and its advertisers started to be regulated in the year of 1996. Health Canada is the department responsible for regulation of all the drugs within the country. Its regulations are based from the Food and Drug Act of 1920. In order protect the thirty three million residents of Canada, Health Canada made it their priority to check all Canada drugs since there are a lot of people who use over-the-counter medicines.

The initial step to regulating Canada drugs started when the Patent Medicine Act of 1909 came to be written. There were some secret formulas issued by doctors that needed documentation and approval. Today, the current system stems from the Food and Drugs act of 1920. This was amended in 1951, requiring all the drug developers to get approval from the federal government before they can advertise their Canada drugs on different tools of media and before they could distribute their products to different distributors. There was also the scandal about thalidomide, a sleeping pill that caused birth defects in the 1960s that made the authorities think of making pharmaceutical companies seek Notices of Compliance from the Canadian government before distributing any of their Canada drugs.

The Notice of Compliance should be issued by Health Canada before the said Canada drugs can be sold in Canadian stores. The notice will only be issued if the company in question is able to fulfill the four criteria set by the government. The criteria include making known the adverse drug reactions of Canada drugs that were observed during clinical trials, complying with the limitation of advertising campaigns, being able to develop a production process to maintain the quality of the products and the application

to change after the initial Notice of Compliance is issued. Drugs are reviewed at specific points in the development process and drugs that do not receive complaints from the consumers will not need to be renewed unless there are changes in the components.

There are three stages that regulators on Health Canada focus on when there is a development process for Canada drugs. The auditioning pharmaceutical company will need to get a Clinical Trial Application from Health Canada before they can be allowed to test any of the Canada drugs being developed on the Canadian people. Once they have finished conducting the clinical trial, the Health Canada officials will assess the submitted outcome and establish irregularities in the application of material. Health

Canada makes sure that companies comply with the standard. Once a product has been approved for distribution, the responsibilities of Health Canada do not stop there. They also have a department that handles reports on adverse reactions to approved Canada drugs- the MedEffect program. The MedEffect website is responsible for publishing product recalls and warning on consumers on the adverse effects of drugs that have been approved. This is a preventive measure that addresses the repercussions that Canada drugs may have to the public.

Canada drugs are classified into two categories during the clinical trial submission review process. The Division 1 drugs, commonly referred to as old drugs, include non prescription Canada drugs like pain killers cough medicines and the like. These drugs are easy to distribute after clinical trials since labeling does not break any copyright on other pharmaceutical companies. The greater scrutiny falls for Division 3, 4 and 8 categorized as new drugs. Typically, these Canada drugs consist of contraceptive, diet pills and cure for serious diseases that are not yet available on the market.

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<h1>Understanding How Canada Drugs are Regulated</h1> Author: <a href='http://www.articleseen.com/profile_canadian online pharmacy .aspx'>canadian online pharmacy </a> The pharmaceutical companies that manufactured Canada drugs and its advertisers started to be regulated in the year of 1996. Health Canada is the department responsible for regulation of all the drugs within the country. Its regulations are based from the Food and Drug Act of 1920. In order protect the thirty three million residents of Canada, Health Canada made it their priority to check all Canada drugs since there are a lot of people who use over-the-counter medicines.

The initial step to regulating Canada drugs started when the Patent Medicine Act of 1909 came to be written. There were some secret formulas issued by doctors that needed documentation and approval. Today, the current system stems from the Food and Drugs act of 1920. This was amended in 1951, requiring all the drug developers to get approval from the federal government before they can advertise their Canada drugs on different tools of media and before they could distribute their products to different distributors. There was also the scandal about thalidomide, a sleeping pill that caused birth defects in the 1960s that made the authorities think of making pharmaceutical companies seek Notices of Compliance from the Canadian government before distributing any of their Canada drugs.

The Notice of Compliance should be issued by Health Canada before the said Canada drugs can be sold in Canadian stores. The notice will only be issued if the company in question is able to fulfill the four criteria set by the government. The criteria include making known the adverse drug reactions of Canada drugs that were observed during clinical trials, complying with the limitation of advertising campaigns, being able to develop a production process to maintain the quality of the products and the application

to change after the initial Notice of Compliance is issued. Drugs are reviewed at specific points in the development process and drugs that do not receive complaints from the consumers will not need to be renewed unless there are changes in the components.

There are three stages that regulators on Health Canada focus on when there is a development process for Canada drugs. The auditioning pharmaceutical company will need to get a Clinical Trial Application from Health Canada before they can be allowed to test any of the Canada drugs being developed on the Canadian people. Once they have finished conducting the clinical trial, the Health Canada officials will assess the submitted outcome and establish irregularities in the application of material. Health

Canada makes sure that companies comply with the standard. Once a product has been approved for distribution, the responsibilities of Health Canada do not stop there. They also have a department that handles reports on adverse reactions to approved Canada drugs- the MedEffect program. The MedEffect website is responsible for publishing product recalls and warning on consumers on the adverse effects of drugs that have been approved. This is a preventive measure that addresses the repercussions that Canada drugs may have to the public.

Canada drugs are classified into two categories during the clinical trial submission review process. The Division 1 drugs, commonly referred to as old drugs, include non prescription Canada drugs like pain killers cough medicines and the like. These drugs are easy to distribute after clinical trials since labeling does not break any copyright on other pharmaceutical companies. The greater scrutiny falls for Division 3, 4 and 8 categorized as new drugs. Typically, these Canada drugs consist of contraceptive, diet pills and cure for serious diseases that are not yet available on the market.
About the Author: Canada Drug Center is an online <a rel="nofollow" href="http://www.canadadrugcenter.com/aboutus.asp">Canadian pharmacy</a> and <a rel="nofollow" href="http://www.canadadrugcenter.com/otc">Canadian over the counter meds</a>. On this website, you’ll find thousands of prescription and non-prescription brand and generic drugs at discount prices. Article Source: <a href='http://www.articleseen.com/Article_Understanding-How-Canada-Drugs-are-Regulated_53461.aspx'> http://www.articleseen.com/Article_Understanding How Canada Drugs are Regulated_53461.aspx</a>

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Canada Drug Center is an online Canadian pharmacy and Canadian over the counter meds. On this website, you’ll find thousands of prescription and non-prescription brand and generic drugs at discount prices.

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