subject: How Are Canada Drugs Developed? [print this page] How Are Canada Drugs Developed? How Are Canada Drugs Developed?
Pharmaceutical sales in Canada have a 3% share of the global market, making the nation the ninth largest in the world market, according to Industry Canada. Before any Canada drugs are authorized for sale in the country, Health Canada, a regulatory body reviews them to assess their safety, efficacy and quality as required by the Regulations of the Food and Drugs Act. What are Canada Drugs? Canada drugs include prescription and non prescription pharmaceuticals, biologically derived products such as vaccines, serums and blood derived products, tissues and organs, disinfectants and radio pharmaceuticals. According to the Food and Drugs Act a drug includes any substance or mixture of substances manufactured, sold or represented for use in:
The diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state or its symptoms in human beings or animals
Restoring, correcting or modifying organic functions in human beings or animals
Disinfection in premises in which food is manufactured, prepared or kept.
Natural health products like vitamin and mineral supplements for which therapeutic claims are made are also regulated as drugs in Canada. How Are Canada Drugs Developed? The development of Canada drugs involves various steps:
Research is the first step in the development of drugs and it begins with scientists developing various chemical and biological substances. Once a substance has been isolated and purified, it is administered to tissue cultures or a variety of animals to check for any significant biochemical, physiological or behavioral changes.
If these initial studies show promising results, further tests are conducted to study the impact of the substance on the immune or the reproductive system of the animals being studied, should be given to achieve a particular effect. If these tests produce the desired results and show that the studied substance is not toxic, the sponsor of the tests makes an application with the Therapeutic Products Directorate or TPD for conducting a clinical trial.
These clinical trials are undertaken with informed and consenting human subjects with the aim to closely monitor the procedures for drug administration and the evaluation of results.
If clinical trial studies prove that the drug has potential therapeutic value that outweighs the risks associated with its use, the sponsor may choose to file a new drug submission with the TPD.
A thorough review of the application and the accompanying information is done by the TPD before giving the necessary approval for the marketing of the drug. However, if there is insufficient evidence to support the safety, efficacy or quality claims, the TPD does not grant a marketing authorization of the drug.
The Canada drugs that have been approved for sale are available through registered pharmacies.
