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Access to Generic Drugs in Canada

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What is a generic drug?

A generic drug is a copy of a brand name drug. The generic drug is pharmaceutically equivalent to the brand name drug: it contains the identical medicinal ingredients, in the same amounts and in a similar dosage form. Generic medications may have different non-medicinal ingredients than the brand name drug, but the company must show that these do not affect the safety, efficacy, or quality of the drug compared to the brand name drug.

There may be many generic versions of the same brand name drug, and these are usually available at a lower cost.

How does Health Canada regulate drugs and other health products?

Health Canada regulates drugs and other health products to make sure they are safe, effective, and of high quality. Companies must submit information to Health Canada before their health product can be sold. The information required depends on the type of product and its level of risk. Once a product is approved for sale, Health Canada continues to monitor its safety, effectiveness, and quality.

How does Health Canada know generic drugs are safe and effective?

A generic drug is made to act in the same way as the brand name drug. A company must demonstrate that its generic drug is 'bioequivalent' to the brand name drug. When two drug products are bioequivalent, it means there is no significant difference in how quickly their medicinal ingredient is absorbed and achieves a certain level in the blood (bioavailability). When products are bioequivalent, they should act the same way in the body, and have the same safety and efficacy.

Drug companies conduct clinical trials to compare the bioavailabity of two drug products, to see if they are bioequivalent. In these trials, healthy human volunteers take the brand name drug and the generic drug, at the same dose in the same way. The level of the medicinal ingredient in the blood is measured to see if the generic drug delivers the same amount of medicinal ingredient at the same rate as the brand name drug.

These studies are submitted to Health Canada as part of a generic drug submission.

What information is in a generic drug submission?

When a company wants to sell a generic drug in Canada, it files a generic drug submission to Health Canada. The submission is called an Abbreviated New Drug Submission (ANDS). It contains information on:

  • the ingredients with amounts and specifications
  • how the drug will be made
  • how the drug will be tested during manufacture
  • how each lot of the drug will be tested before being distributed or sold

A generic drug submission also includes results of tests to show that the drug is bioequivalent to the brand name drug. The tests that are required depend on the details of the generic drug and also the current laws, regulations and guidance documents.

What generic drug submissions are currently under review?

You can see the generic drug submissions (abbreviated new drug submissions, or ANDSs) that are currently under review in Canada by viewing the Generic Submissions Under Review (GSUR) List.

 

How does Health Canada review generic drug submissions?

All drug submissions are reviewed by scientists in the Health Products and Food Branch (HPFB). Generic drug submissions go through the same process as brand name drug submissions:

  • HPFB performs a thorough review of the submitted information, sometimes using external consultants and advisory committees
  • HPFB evaluates the safety, efficacy and quality data to assess the potential benefits and risks of the drug
  • For generic drugs, HPFB ensures the drug meets the regulatory requirements, including pharmaceutical equivalence and bioequivalence
  • HPFB reviews the information that the sponsor proposes to provide to health care practitioners and consumers about the drug (e.g. the label, product brochure)
  • If this evaluation shows that the generic drug meets all regulatory requirements (including patent and data protection considerations) the drug is issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN). The NOC and DIN permit the sponsor to market the drug in Canada and indicate the drug's official approval in Canada.

How can I learn about Health Canada decisions on generic drugs?

If the Health Products and Food Branch (HPFB) review shows that the generic drug meets all regulatory requirements, the drug is issued a Notice of Compliance (NOC), as well as a Drug Identification Number (DIN). These are publicly available in the NOC database and Drug Product Database, respectively. In addition, Health Canada announced in August 2018 that it will publish regulatory decision summaries for final positive and negative decisions for certain prescription generic drug submissions that might be of interest to stakeholders.

What laws apply to generic drugs?

The Food and Drug Regulations under the Food and Drugs Act apply to all drugs, including generic drugs. A generic drug must be approved by Health Canada before it can be sold.

Health Canada has written many guidance documents to explain the data that should be submitted before a drug can be approved. These are used by both manufacturers and Health Canada scientists so that generic drugs are safe, effective, and of high quality.

There are other laws and regulations which also apply to generic drugs. One example is the Narcotic Control Regulations under the Controlled Drugs and Substances Act. These regulations apply to any narcotic, whether it is in a brand name drug or a generic.

How long does it take before a generic drug can be sold in Canada?

The length of time before a generic drug can be sold in Canada depends on several factors. Generic drug manufacturers have to:

  • conduct studies to design and test their new generic drug
  • respect national and international patent and data protection requirements
  • file a drug submission to Health Canada, and receive approval

Designing and testing a new generic drug can take several months or even years. Then, a new generic drug must be approved by Health Canada. In 2016-17, the average time for approval was approximately fifteen months.

Health Canada cannot approve a drug until patent and data protection requirements have been met. Brand name drugs are usually protected by patents. The generic drug manufacturer has to either:

  • challenge the patents in court, or
  • wait until the patents expire.

You can find out if there are patents on a particular drug and when they expire by searching the Patent Register.

Many new brand name drugs are innovative drugs and also have 'data protection', which means there are regulations that give them a period of market exclusivity. Health Canada cannot approve a generic copy of innovative drugs for at least 8 years.

You can find out if a specific drug is protected by searching the Register of Innovative Drugs.

The Canada-European Union Comprehensive Economic and Trade Agreement (CETA) has introduced another protection, called a Certificate of Supplementary Protection. This provides up to two years of additional protection to a drug product, after the patent expires.

Why might generic drugs look different than brand name drugs?

Generic drugs may look a bit different than the brand name form of the same medication. Generic drugs may have different nonmedicinal ingredients. These may affect the colour, size or shape of the generic drug. Many generic manufacturers also have their own marking or symbol that they put on the generic drug.

Even though a generic drug may look different than the brand name drug, it is still bioequivalent, and it will still act the same way in the body as the brand name drug.

How do I know if the drug I am taking is a generic?

The easiest way to know if the drug you are taking is a generic is to ask your pharmacist.

You can also look up the drug on the Notice of Compliance (NOC) database. A generic drug will have a Canadian Reference Product (CRP) listed on every NOC issued for that generic. A CRP is usually the brand name drug, but can also be another generic drug if the original brand name drug is no longer marketed in Canada. The generic drug is bioequivalent to the Canadian Reference Product that is listed on the NOC.

Why did the pharmacist give me a generic drug?

Many drug plans have rules that limit payment for brand name drugs once generic drugs are available. Based on provincial or territorial laws pharmacies then automatically give patients the generic version of the drug, even if they were previously taking the brand name drug.

For more information on your situation, talk to your pharmacist or your provincial or territorial health department, or consult your health care plan.

How does Health Canada monitor the safety and effectiveness of generic drugs?

Generic drugs are monitored in the same way as other drugs. Scientists and clinicians in the Health Products and Food Branch of Health Canada evaluate reports from consumers, manufacturers, health professionals and other regulators. When issues are identified, actions can be taken, including:

  • publishing and distributing new safety information for healthcare professionals and patients
  • changing the product's labelling
  • removing the product from the market

For more information on how Health Canada monitors health products, visit MedEffect Canada.

What if I have a reaction to a drug?

You can report adverse reactions to drugs (generic drugs and brand name drugs) to your medical professional, to a hospital, or to the company that made the product. You can also report them to Health Canada through MedEffect Canada or by phone at 1-866-234-2345.

Where can I find information on approved generic drugs?

Product monographs are a good source of Health Canada-approved information about generic and brand name drugs. A product monograph is a factual, scientific document on a drug product. It describes the properties, claims, what the drug is used for, and conditions of use of the drug and contains any other information that may be required for optimal, safety and effective use of the drug. Manufacturers are required to develop a product monograph, and Health Canada reviews it as part of the drug review process.

The information in a product monograph for a generic drug is based on the product monograph for the brand name drug. Some sections will be a bit different. For example, the generic drug product monograph will only show those strengths or dosage forms that are approved. The brand name drug may have additional strengths. Results of the studies that compared the generic drug to the Canadian Reference Product (the brand name drug) will also be included in the product monograph for the generic drug.

You can find the complete product monograph for a specific drug by searching Health Canada's Drug Product Database.

You can find the consumer information for some drugs by searching Health Canada's Drugs and Health Products Register. This database was designed to help consumers find information about drugs and other health products, and includes the consumer information from product monographs.

Health Canada publishes many databases about drug products. For more information on the different databases, and links to each of them, visit the Drug Products page.

How do product monographs for generic drugs get updated?

All manufacturers need to keep their labelling information up to date. Generic drug manufacturers have to add any changes to the information for the brand name drug, to the product monograph for their own generic drug. Health Canada reviews the new information and publishes product monographs on its website. Health Canada also publishes a table to help generic drug manufacturers stay up to date with changes to safety information for brand name drugs.

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