What is the process for approving dementia drugs in Canada?

Key steps

In Canada, drugs for any health condition are reviewed by the Pharmaceutical Drug Directorate of the Health Products and Food Branch at Health Canada.

This Pharmaceutical Drug Directorate is responsible for making sure all drugs are:

• safe
• effective
• high quality

Before a drug manufacturer can submit for a drug for approval in Canada, they must test the drug at each stage of its development. Then they provide data from that testing to the directorate when they submit it for consideration.

Here is more information about the process for any drug to be approved in Canada, including drugs for dementia.

Step 1: The drug goes through pre-clinical development

First, the manufacturer completes laboratory tests of the drug in a variety of cells, tissue samples and/or animal models This helps determine the effects of the drug in different amounts and over different time periods.

If the required drug dosage is found to cause no serious or unexpected harm, and is effective on the condition that it is treating, the drug manufacturer will apply to the Pharmaceutical Drug Directorate of Health Canada to begin clinical trials.

In total, pre-clinical development usually takes two to three years to complete.

A Health Canada research ethics board must review and accept the application before clinical trials can begin.

Step 2: The drug goes through phase 1 clinical trials

In phase 1 clinical trials, the drug is tested for safety, dosage range, side effects and more.

• Phase 1 clinical trials typically involve fewer than 100 healthy humans.
• These trials usually consist of single doses given at one time under carefully monitored conditions.
• Phase 1 trials generally take at least one year to complete.

If the results are successful, phase 2 clinical trials can begin.

Step 3: The drug goes through phase 2 clinical trials

In phase 2 clinical trials, information is gathered about how well the drug works to treat the health condition.

• These trials also confirm the drug’s safety in a wider population and determine the best dose to give.
• Phase 2 clinical trials typically give the drug to a group of 100 or more people.
• Usually, phase 2 clinical trials take at least two to three years to complete.

If the drug is found to be safe in the doses required, phase 3 clinical trials will occur next.

Step 4: The drug goes through phase 3 clinical trials

In phase 3 clinical trials, researchers continue to monitor the drug safety. The goal is to ensure that if any severe side effects are reported, they will not be a cause for concern for the general population.

• Phase 3 clinical trials also make sure that all serious side effects of the drug, if any exist, are well recognized.
• Phase 3 clinical trials typically involve a larger number of participants, usually between 1,000 and 3,000 people.
• Most often, one group receives the drug treatment being researched, and a matching group receives a placebo (a treatment with no effect).

During the clinical trial itself, usually both the researchers and participants will not know who receives the drug and who receives the placebo. (After the trial ends, researchers and participants may find out with more certainty which person received the placebo and which received the drug.)

This process can help make sure that the clinical trial results reported are fair and not biased. However, sometimes it is not possible to do this, depending on the type of drug being researched.

Phase 3 clinical trials usually take anywhere from one to three years to complete, but this can vary.

If the drug is successful in treating the health condition right until the end of the phase 3 clinical trials, a New Drug Submission can be sent to Health Canada for approval.

Step 5: The drug is submitted to Health Canada

If the results from the phase 3 clinical trials are successful, the drug manufacturer can create a New Drug Submission for the Pharmaceutical Drug Directorate at Health Canada.

The directorate reviews all the information and data gathered during the development of the drug. They also assess the risks and benefits too.

Step 6: Health Canada delivers a decision

If it Pharmaceutical Drug Directorate at Health Canada finds that, for a specific group of people and condition, the benefits of the drug are higher than the known risks, a Notice of Compliance (also known as an NOC) will be issued. This means the drug can be marketed in Canada.

For conditions that are life-threatening or cause severe impairment (like dementia), Health Canada can allow a drug to be accessed by the public, but with conditions attached. This is called a Notice of Compliance with conditions (also known as an NOC/c). This means the drug manufacturer must complete more studies to confirm the drug’s benefit.

In some cases, the drug also enters phase 4 clinical trials

Phase 4 clinical trials can happen after a drug has been approved by Health Canada and is available to the public.

These trials are not always required, but they are often conducted to learn more about potential side effects of the drug over a long period of time and with more people using it.

For example, people with other medical conditions, of different ages or of other genders may be researched.

During phase 4 clinical trials, information is collected about the long-term risks and benefits of the drug. And sometimes, these trials are required by regulatory authorities, such as Health Canada.

This phase, if undertaken, may take around two to four years to complete.

Frequently asked questions we hear about drug approvals and dementia

Over the years, we at the Alzheimer Society have been asked many questions about drug development and drug access. Here are some of the most common questions we have received, and some answers, too.

Q. Can I get access to a drug before it has been approved?

The Health Products and Food Branch of Health Canada can approve the early release of a drug under its Special Access Program.

Some kinds of health-care providers can request for a drug to be released early when they are treating a person with a serious or life-threatening illness.

However, this request can only be made if one of the following is true:

• all other traditional treatments have failed
• all other traditional treatments are unsuitable
• all other traditional treatments are not available in Canada

For example, some drugs being researched for the treatment of dementia may be obtained through this program.

A person’s physician can contact the Health Products and Food Branch or the drug’s manufacturer to obtain information about access.

Q. What drugs are currently approved to treat dementia in Canada?

In Canada, there are currently some drugs approved for treating specific types of dementia. As there are many different types of dementia, each has recommended medications.

Visit our webpage about the medications approved to treat Alzheimer’s disease and other dementias to learn more.

To learn more about which drugs are right for you, always ask your own doctor or health-care provider.

Q. How can I find clinical trials and research studies recruiting people with dementia in Canada?

For information about clinical trials and research studies now recruiting people affected by dementia in your community, please visit alzheimer.ca/find-studies.

On this website, you will find research studies available both online and in-person across Canada for people affected by dementia. There are sometimes opportunities for health-care providers as well.

For more information, email info@alzheimer.ca or call 1-855-705-4636 (INFO).

To information about all clinical trials being conducted around the world, please visit clinicaltrials.gov. To find Canadian clinical trials, you can filter your search by selecting “Canada” in the search filters. 

Q. What should I know before getting involved in a clinical trial?

There are potential risks and benefits to participating in any kind of research. So it’s important to consider both when making the decision to get involved in a research study or clinical trial.

Visit alzheimer.ca/clinicaltrials to read our checklist of questions to ask, to learn about the importance of research ethics boards and more.

The information on this page is also available to read in a print-friendly information sheet: Download Drug Approval Process or contact your local Society for a copy.

Acknowledgements and Disclaimer

The information on this webpage is informed by research and the experiences of people living with dementia. We thank Mario Gregorio, a person living with dementia, and Dr. Tejal Patel, Clinical Associate Professor, University of Waterloo, for their generous contributions to the development of this resource.

This information is for your general use. Be sure to talk to a qualified health-care provider before making any health-related decisions. Information that the Alzheimer Society provides does not replace your relationship with your health-care professional. This information is not intended to replace clinical diagnosis or treatment. 

This webpage was last updated on April 28, 2023. If you have any questions, comments or concerns about this webpage please email publications@alzheimer.ca.