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Drugs for children and youth in Canada : Our approach - Canada.ca
18 avr. 2025
legacy-hc-2025-04-21
ID 145720
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Drugs for children and youth in Canada : Our approach - Canada.ca
1 janv. 2026
hc-20260101
ID 404962
updated10 sections changed
10 sections modifiées0 ajoutées0 retirées+23 / -32 lignesVariation: 28%
--- +++ @@ -3,24 +3,22 @@ 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-National Priority List of Pediatric Drugs-Pediatric pilot Contact us 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:+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 disease can present differently in children and youth than in adults+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 and is made up of 2 teams:-Pediatric Therapeutics Division-Office of Pediatric Therapeutic Policy+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@@ -29,16 +27,20 @@ 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-We are focusing our initial efforts on implementing several key measures to support the action plan. We intend to:-modernize regulations to require drug manufacturers to provide Health Canada with meaningful information about the safety and effectiveness of drugs in children and youth-develop a National Priority List of Pediatric Drugs (priority list) that are available elsewhere and needed in Canada-identify the regulatory pathways and flexibilities that can be implemented to encourage industry to bring these products to Canada+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:+Final list+Background+Pediatric External Reference Group (PERG)+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:+Pilot on pediatric development plans and studies 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 brains. 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.+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@@ -59,6 +61,9 @@ 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:+Drug Product Database Post-market surveillance Health Canada collects and evaluates reports of suspected adverse reactions@@ -67,37 +72,23 @@ 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.+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: Special Access Program-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:-Drug Product Database Summary Basis of Decision For information on why Health Canada authorized certain drugs and medical devices for sale in Canada: Summary Basis of Decision Past consultations Closed: Consultation on the draft National Priority List of Pediatric Drugs-National Priority List of Pediatric Drugs-Health Canada is working with stakeholders to develop a National Priority List of Pediatric Drugs. This priority list will identify 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. A final list will be made publicly available in 2025.-Learn more:-Background-Pediatric External Reference Group (PERG)-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:-Pilot on pediatric development plans and studies Contact us Centre for Policy, Pediatrics and International Collaboration (CPPIC) 100 Eglantine Dr-Address locator: 0603B+Address locator: 0601B Tunney's Pasture Ottawa ON K1A 0K9 Email: brdd-cppic_brdd-cppci@hc-sc.gc.ca Page details-Date modified:-2024-12-23+2025-09-02