Canada's approach to drugs for children and youth

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Medications for children and youth

Children and youth (17 years of age and younger) have unique health and safety needs. Medications can have different effects on them than on adults. This is because:

Medicines need to be studied in pediatric populations to ensure they are safe and effective for children and youth. These studies are complex and challenging. As a result, many medications that are prescribed for children and youth are prescribed off-label, which means outside of the approved use of the drug in Canada.

Progress is being made worldwide to encourage the study of health products in pediatric populations. This will help to establish stronger evidence and increase access to more products that are specifically approved for use in children and youth.

What we do

The Centre for Policy, Pediatrics and International Collaboration (CPPIC) oversees Health Canada's policies, processes and regulations for therapeutic products in children and youth. As part of this work, CPPIC has developed an action plan to ensure that medications for children and youth meet the same high standards as those established for adult medications.

CPPIC resides within the Health Products and Food Branch and is made up of 2 teams:

Pediatric Drug Action Plan

Health Canada's Pediatric Drug Action Plan was developed in 2020 after extensive review and consultations with key stakeholders. The action plan will help ensure that children and youth in Canada have access not only to the medicines they need, but also to age-appropriate formulations.

As part of the action plan, CPPIC is working with other government departments, as well as external partners and stakeholders, to accomplish 3 goals:

We are focusing our initial efforts on implementing several key measures to support the action plan. We intend to:

Clinical trials

In Canada, pediatric patients can take part in clinical trials if they assent (depending on age) and their parents give their consent.

Health Canada is in the process of modernizing how we regulate clinical trials. We are also making policy changes to reduce administrative burdens in clinical trials, including those involving children and youth.

Clinical trials in children and youth help medical practitioners understand how a treatment will uniquely affect children and youth. Data collected from adult clinical trials does not always reflect how the medicine will impact children's growing bodies and brain. Safeguards are put in place to ensure children and youth are not exposed to inappropriate risks. For example, clinical trials are only conducted in a pediatric population where the clinical benefit outweighs any potential risks of the treatment.

Find a clinical trial

You can find information on clinical trials that are open in Canada on the Clinical Trials Database. Search for clinical trials in pediatric populations by selecting "pediatric" under the "study population" field.

For other public registries that help find suitable trials:

For information on rare diseases, including those affecting children and youth:

For drug manufacturers and organizations on how to apply for a clinical trial:

Authorizing and monitoring pediatric medications

Health Canada has established practices for authorizing and monitoring drugs and medical devices.

Market authorization of drugs and medical devices

Drugs and medical devices are authorized for sale in Canada once they have successfully gone through a scientific review process.

For information on how to file for market authorization of a drug or medical device in Canada, please contact the appropriate directorates of the Health Products and Food Branch.

Post market surveillance

Health Canada collects and evaluates reports of suspected adverse reactions after drugs and medical devices are authorized for sale in Canada.

Suspected adverse reactions, including those involving children and youth, are to be reported to the Canada Vigilance Program, led by the Marketed Health Products Directorate.

Special Access Program

In some circumstances, non-marketed drugs may be requested through the Special Access Program. The program gives access to non-marketed drugs for serious or life-threatening conditions when conventional therapies have failed, are unsuitable or offer limited options.

Requests must be initiated by a practitioner and are considered on a case-by-case basis.

Learn more:

Drug Product Database

To find drugs that have been approved for sale in Canada, including the conditions for which they were approved, and their complete product monographs:

Summary Basis of Decision

For information on why Health Canada authorized certain drugs and medical devices for sale in Canada:

Upcoming consultations

We will be seeking feedback in the near future on the:

Pediatric pilot

Health Canada is conducting a pilot to encourage sponsors to submit pediatric studies for drugs approved for adults in Canada. The pilot starts on February 26, 2024, and is expected to run for at least 2 years.

Learn more:

Contact us

Centre for Policy, Pediatrics and International Collaboration (CPPIC)
100 Eglantine Dr
Address locator: 0603B
Tunney's Pasture
Ottawa ON K1A 0K9


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