subject: Regulation Governing Canadian Drugs [print this page] Regulation Governing Canadian Drugs Regulation Governing Canadian Drugs
The safe manufacture and storage process of Canadian drugs is regulated by the drugs section of the Food & the Drugs Act of Canada. Health Canada, the federal regulator, has looked after the country's pharmaceutical companies and advertisers since it establishment in 1996. The organization's drug development and advertising regulations are based on the Food & Drug Act of 1920. Health Canada plays an active role in ensuring that the Canadian drugs you buy are safe and effective. The organization strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products in Canada. Laws that Govern Canadian Drugs The provisions of the Controlled Drugs and Substances Act (CDSA) govern the production, distribution, possession and import of various Canadian drugs. According to the prevailing rules, controlled Canadian drugs and substances for medical treatment can only be obtained through a prescription from a licensed medical practitioner. The rules also provide that a prescription drug can only be legally possessed and used by a person for whom it has been prescribed. Persons who are found to be in unlawful possession or guilty of exporting, importing, trading or producing such Canadian drugs without the necessary clearances may be imprisoned or fined. According to the current laws, all pharmaceutical companies must seek Notices of Compliance (NOC) from the Canadian government due to the scandal surrounding thalidomide, a sleeping pill that was found to cause birth defects in the 1960s. This NOC must be sought from Health Canada which seeks fulfillment of four criteria:
Providing information about adverse drug reactions from clinical trials
Observing advertising limitations
Developing a production process that maintain drug quality
Applying for each change in the process
Health Canada carries out regular reviews of drugs in Canada at specific points in the development process. Role of Health Canada Regulating Canadian Drugs Health Canada plays a crucial role in the regulation of the Canadian drugs segment. This is done in three ways:
Every drug developer in Canada has to make a clinical trial application before testing any drug on the public.
Once an approved clinical trial is completed, Health Canada officials conduct a review to assess research reports and check for irregularities.
The federal regulator offers product labeling standards to companies who clear submission reviews.In addition to these steps, the Canadian public can report any adverse reactions caused by the approved Canadian drugs. Potential candidates for drugs are divided into two categories. The first category refers to old drugs and includes non prescription pain killers, cough medicines or generic products. The second category refers to new drugs that include prescription drugs for serious disorders.
