Who Regulates Canada Drugs?

Table of Contents


I. In short, the answer is Health Canada.

a. What is Health Canada?

b. What roles does it play?

II. More specifically, a branch of Health Canada regulates Canada drugs.

III. This branch regulates all drugs sold on the Canadian market.

a. These include both prescription and non-prescription types.

b. Natural health products are included too but in a different way.

IV. Their regulation ensures that Canada drugs are safe.

a. What does their review process look like?

b. Why do some drugs get rejected during this process?

c. How long is the process?

V. Overall, Health Canada is there to keep a constant eye on any drugs.


If you’re new to ordering drugs from Canada online, you may wonder how safe they are. After all, you don’t know who regulates them. What if Canada doesn’t regulate their drugs as well as America?

Well, to put those worries to rest, Canada Drug Warehouse is here. We’ll help explain who regulates Canada drugs and how effective they are.

A Canadian flag flaps in the wind in a mountainous region.

In short, the answer is Health Canada.

Much like how the United States has the FDA, Canada has Health Canada. It’s the one federal institution in charge of drug regulation.[1]

What is Health Canada?

Health Canada is not just a drug regulator, however. It’s also an institution in charge of maintaining and improving the health of Canadians. So it works towards fulfilling the following goals:[2]

  • Minimizing any health risks to people and their environment
  • Encouraging Canadians to stay healthy
  • Providing efficient, accessible health services
  • Removing any health inequalities
  • Displaying health information so Canadians can make informed life choices

What roles does it play?

With these goals in mind, Health Canada plays several roles:

  • Administrator
    • Health Canada acts as an administrator of the Canada Health Act.[3] So Canada can enforce safety rules and other important criteria for health services.
  • Health Services Funder
    • To support health services for First Nations and Inuit (that is, Indigenous peoples of Canada), Health Canada offers them funds. Health Canada also provides grants and contributions to a number of other communities.
  • Health Benefits Provider
    • First Nations and Inuit also receive other health services from Health Canada. For instance, Health Canada provides primary care services for reserves and isolated areas. Generally, these services are only provided where there are no available provincial services. They also provide additional health benefits for eligible First Nations and Inuit. These benefits cover the following:
      • Pharmaceuticals
      • Dental services
      • Vision services
      • Medical transportation
      • Medical supplies and equipment
      • Mental health counseling
  • Product Regulator
    • For this role, Health Canada reviews the safety of products that are critical to the health of Canadians. That includes managing and approving the following:
      • Biologics
      • Consumer goods
      • Foods
      • Medical devices
      • Natural health products
      • Pesticides
      • Pharmaceuticals
      • Toxic substances
  • Information Provider
    • Health Canada also provides health information to Canadians. To enhance this information, they conduct high-quality research. They also support policy development and regulate products.

So in short, Health Canada not only regulates Canada drugs. It also does plenty more to care for the health of Canadians.

More specifically, a branch of Health Canada regulates Canada drugs.

So, Health Canada is in charge of drug regulation and a number of other health-care programs. But what branch of this institution actually handles just the drug regulation?

As noted by the Government of Canada,[4] that happens to be the Health Products and Food Branch (HPFB).

The HPFB is a national authority on therapeutic and diagnostic products in Canada. They oversee drugs as well as medical devices, disinfectants, and disinfecting sanitizers.

A bunch of Canada drugs are all piled together.

This branch regulates all drugs sold on the Canadian market.

As Canada’s national overseer of drugs, the HPFB regulates all drugs sold on the Canadian market. But they handle specific types in slightly different ways.

These include both prescription and non-prescription types.

Under the Food and Drugs Act,[5] drugs are defined as a substance or mixture of substances that are made, sold, and described for:

  • Diagnosing, treating, mitigating, or preventing a health issue
  • Reviving, fixing, or otherwise altering bodily functions for humans or animals
  • Disinfection for situations involving the preparation of food

So to support that legislation, the HPFB regulates both prescription and non-prescription drugs.

Natural health products are included too but in a different way.

Unlike both prescription and non-prescription drugs, natural health products are not reviewed under the Food and Drugs Act. They still are considered to be a type of drug. But they are regulated by the HPFB under the Natural Health Products Regulations.[6]

A lady in a lab coat is handling scientific equipment.

Their regulation ensures that Canada drugs are safe.

To keep all Canada drugs safe for Canadians, the HPFB puts them through a review process.

What does their review process look like?

The HPFB’s review process involves several steps:

  1. A sponsor wants to market their drug in Canada. So they submit information and data on it to the HPFB for approval.
  2. The HPFB reviews the submitted information themselves. But sometimes they'll review it alongside external consultants and advisory committees.
  3. Then, the HPFB examines the safety, efficacy, and quality of the data. This allows them to properly determine potential benefits and risks of the drug.
  4. The HPFB goes on to review drug information meant for health-care professionals and patients.
  5. If the HPFB decides that the drug’s benefits outweigh its risks, they’ll give the drug a notice of compliance and drug identification number. Both forms allow the drug to be marketed in Canada.
  6. Lastly, Health Canada laboratories may continue to test the drug. That way, the drug’s safety, efficacy, and quality can be monitored.

Why do some drugs get rejected during this process?

During the HPFB’s review, some drugs may get rejected. When this happens, it’s usually due to a lack of evidence to support:

  • Safety
  • Efficacy
  • Quality

When that happens, the HPFB will not give the drug’s sponsor the authority to market the drug in Canada.

But that isn’t the end for that sponsor. Instead, the HPFB will allow them to do the following to change the HPFB’s decision:

  • Providing additional information
  • Re-submitting a drug approval request with additional supporting information
  • Asking the HPFB to reconsider

How long is the process?

There does not seem to be a typical length for each HPFB drug review process. After all, it depends on a number of factors:

  • The drug submission itself
  • Size and quality of the submission
  • The HPFB’s workload and human resources

A man is pouring red Canada pills into his left hand.

Overall, Health Canada is there to keep a constant eye on any drugs.

As you can see, Canada drugs are perfectly safe. You just need to know how to stay safe when buying them online. And don’t forget that when you buy online, your order may come from other countries. But otherwise, Health Canada does its best to keep all drugs in Canada safe just like the FDA does for America.

DISCLAIMER: The content in this article is intended for informational purposes only. This website does not provide medical advice. In all circumstances, you should always seek the advice of your physician and/or other qualified health professionals(s) for drug, medical condition, or treatment advice. The content provided on this website is not a substitute for professional medical advice, diagnosis or treatment.