Canada's approach to drugs for children and youth
On this page
- Medications for children and youth
- What we do
- Pediatric Drug Action Plan
- National Priority List of Pediatric Drugs
- Pediatric pilot
- Clinical trials
- Authorizing and monitoring pediatric medications
- Past consultations
- Contact us
Medications for children and youth
Children and youth (17 years of age and younger) have unique health and safety needs. This is because:
- child and youth bodies and brains are still developing
- the same condition can present differently in children and youth than in adults
- children and youth may absorb and metabolize medications differently than adults
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.
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 to the medicines they need and 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:
- improve access to pediatric medicines and formulations
- increase the development of pediatric medicines and formulations
- provide more information to people in Canada on pediatric activities and data
National Priority List of Pediatric Drugs
Health Canada, in collaboration with stakeholders, has developed a National Priority List of Pediatric Drugs. The list identifies drugs needed to address unmet pediatric health needs in Canada.
A public consultation on the draft National Priority List of Pediatric Drugs took place from October 21 to December 20, 2024.
Learn more:
Pediatric pilot
Health Canada is conducting a pilot to encourage sponsors to submit pediatric studies for drugs approved for adults in Canada. The pilot started on February 26, 2024, and is expected to run for at least 2 years.
Learn more:
Clinical trials
In Canada, pediatric patients can take part in clinical trials if they assent (depending on age) and their parents give their consent.
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 brains.
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:
- ClinicalTrials.gov
- International Standard Randomized Controlled Trials Number Registry (current controlled 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, contact the appropriate directorates of the Health Products and Food Branch.
Drug Product Database
Find drugs that have been approved for sale in Canada, including the conditions for which they were approved, and their complete product monographs:
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
The Special Access Program may be used to 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:
Summary Basis of Decision
For information on why Health Canada authorized certain drugs and medical devices for sale in Canada:
Past consultations
Closed: Consultation on the draft National Priority List of Pediatric Drugs
Contact us
Centre for Policy, Pediatrics and International Collaboration (CPPIC)
100 Eglantine Dr
Address locator: 0601B
Tunney's Pasture
Ottawa ON K1A 0K9
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