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Food and Drug Act : ウィキペディア英語版
Food and Drugs Act

The Food and Drugs Act (formal title "An Act respecting food, drugs, cosmetics and therapeutic devices") 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 (including personal cleaning products such as soap and toothpaste). It was first passed in 1920 and most recently revised in 1985. It attempts to ensure that these products are safe, that their ingredients are disclosed and that drugs are effective and are not sold as food or cosmetics. It also states that cures for Schedule A diseases (the most serious, including cancer), cannot be advertised to the general public.
==Background==
After the launch of the Federal Department of Health in 1919, the Food and Drugs Act was later presented in late 1920.Rules and regulations developed under the Act established the requirements needed for licensing and creating drugs in Canada. The Minister of Health had the right under this Act to cancel or suspend licenses for companies failing to comply with the requirements.〔(background information on the Act of the bill )〕
The Food and Drugs Act was not significantly modified until 1947, in which the foundations were laid out for the current market today. During 1951, drug manufacturers were required to submit a file for each new drug prior to marketing their product. However during the early 1960s, the drug thalidomide surfaced into the market, which caused severe birth defects along with resulting in thousands of infant deaths.
Due to the problems caused by the drug thalidomide, the Act was revisited and strengthened by the department of Health. The revised version placed new requirements for manufacturers to fill out evidence for the efficacy in seeking a Notice of Compliance.
The current Model for drug regulation in Canada focuses on pre-market activities. Once the Notice of Compliance has been received from Health Canada and it passes, the drug can then be administered into the market. The manufacturer must meet all the required obligations before being available to the public, but once the drug passes with no adverse reaction or no changes needed to the drug's formula, it may never be subjected for review by Health Canada again. Recent social trends and Medical are putting pressure on this system to progress.

抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)
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