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Research Journal of Pharmacy and Technology
Year : 2020, Volume : 13, Issue : 4
First page : ( 2040) Last page : ( 2044)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2020.00367.4

Regulatory Drug Approval Process in Canada

Zachariah C. Jimson*, Kamaraj Raju

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur – 603203, Kanchipuram, Tamil Nadu, India

*Corresponding Author E-mail: jimsonzachariah@gmail.com

Online published on 30 April, 2020.

Abstract

A regulatory procedure by which an applicant obtains the right to sell their products in their respective market of sale is called the drug approval process. Most of the products, including drugs to be marketed in Canada are authorized by the Health Products and Food Branch (HPFB) of Health Canada, more rightly, under the Therapeutic Product Directorate (TPD) for Drugs. The regulation of drugs varies from country to country. The drug approval procedure in Canada is examined closely by its regulatory body which is discussed. It consists of different stages of drug submission requisites for a safe and efficient regulatory strategy. This article specifically focuses on an elaborate study on Marketing Authorization of Drugs in Canada. HPFB of Health Canada is the National Regulatory Body which is accountable for assessing, and regulating the efficacy, safety and quality of drugs and other health products of Canada. The HPFB's responsibility is to regulate the health-related risk-benefit ratio of health products and foods for Canadians.

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Keywords

Canada, New Drug Submission, Therapeutic Product Directorate, Health Canada, Health Products and Food Branch, Notice of Deficiency, Common Technical Document.

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