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What is Canadas Health Products and Food Branch? Health Canadas HPFB is the national authority that is responsible for regulating, evaluating, and monitoring the safety, efficacy, and quality of drugs, biologics, genetic therapies and other health products available for the Canadian marketplace.
Regulatory approval Before a drug product is authorized for sale in Canada, the drug manufacturer must submit scientific evidence of the products safety, efficacy, and quality to Health Canada for review and approval.
Pharmaceutical regulations are defined as the combination of legal, administrative, and technical measures that governments take to ensure the safety, efficacy, and quality of medicines, as well as the relevance and accuracy of product information (Lezotre, 2013; Rgo and Santoso, 2008).
A team of CDER physicians, statisticians, chemists, pharmacologists, and other scientists reviews the companys data and proposed labeling. If this independent and unbiased review establishes that a drugs health benefits outweigh its known risks, the drug is approved for sale.
Obtaining a licence requires submitting to Health Canada detailed information on the product, including: medicinal ingredients. source. potency. non-medicinal ingredients, and. recommended use.
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Drug approval and drug regulations The drug approval process requires four phases, which include preclinical investigation, clinical investigation, review of the new drug application, and postmarketing surveillance.
Regulatory strategy is the way of planning and carrying out the regulatory activities that are needed to get and keep the approval of a product in different countries. - Regulatory strategy helps pharma companies to make, sell, and use their products in a fast, effective, and lawful way.
At the federal level, drugs are regulated primarily through the U.S. Department of Health and Human Services (HHS). Within HHS, the two departments that are most involved are the U.S. Food and Drug Administration (FDA) and the Centers for Medicare Medicaid Services (CMS).

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