INDUSTRY INSIDER: What is the difference between FDA approved drugs and Health Canada approved drugs?

A quick primer by Alice Wolfe, author of Canada Pharmacy Online, via PRLog, provides a list of differences between Health Canada-approved and FDA-approved drugs. Retailers should know about these differences in order to address concerns and questions from customers.

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What is the difference between FDA approved drugs and Health Canada approved drugs?


When comparing generic and brand name drugs approved in both Canada and the US, you will always find the generic versions cheaper than their brand-name counterparts.


PR Log (Press Release) – Before a drug, whether it’s a brand name or generic version, must be approved by a regulatory government body in each country in which it is to be sold in. In Canada, Health Canada ensures that all drugs are safe and meet specific requirements before entering the market and for the US, it’s the Food and Drug Administration (FDA).

Before approving a drug for sale in their country, Health Canada and the FDA will evaluate the drugs’ safety, efficacy, and quality. The drug manufacturer must provide substantive proof of the product ingredients and safety. Both Canada and the US have slightly different standards when it comes to approving drugs so it’s not uncommon to see a drug approved for use in one country and not approved in another.

When comparing generic and brand name drugs approved in both Canada and the US, you will always find the generic versions cheaper than their brand-name counterparts. In Canada, the Canadian government negotiates drug prices with the manufacturer and the PMPRB (Patented Medicine Prices Review Board) ensures the sale price of patented drugs is fair. In the US, there is no government body regulating pricing so drug manufacturers can charge whatever they want.


There are more differences between Canadian- and US-approved generic drugs. Because it different patent laws, Health Canada can approve generic drugs for the Canadian market 5 years earlier than the FDA can approve the same drug in the US. Also, because of the different processes and laws required for a drug to be approved in each country, it may take longer for a drug to be approved in one country than the other. It may already be available in one country shortly before its approved or not approved in another.

For a list of Health Canada approved drugs, visit the Health Canada website. [http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/ind ...]
For a list of US FDA approved drugs, visit the FDA website. [http://www.accessdata.fda.gov/scripts/cder/drugsatfda/in ...]

SOURCE: PR Log