About the National Priority List of Pediatric Drugs
Learn about the efforts to develop a priority list of pediatric drugs in Canada.
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Background
Some medicines that are available in child-friendly formats and are approved for use in children in other jurisdictions are not available in Canada. Making these drugs available in Canada will benefit children who need these medicines or who need child-friendly formulations.
Health Canada is taking steps to address this issue by developing a National Priority List of Pediatric Drugs. This list is a key initiative of the Pediatric Drug Action Plan.
Learn more about the Pediatric Drug Action Plan.
The list will help identify drugs containing medicinal ingredients needed for pediatric populations that are approved for sale in other jurisdictions, but in Canada are not yet:
- approved for sale
- available in a child-friendly format or
- indicated for use in children
We expect to update the list from time to time when needed.
Developing the draft list
To help us develop a draft list of pediatric drugs, we formed the Pediatric External Reference Group in early 2023. This group is made up of experts from the pediatric medical and pharmacist communities across Canada.
The group's main objectives are to:
- help us engage with the broader medical community to nominate drugs for consideration on the list and
- offer expert advice and recommendations to us on the draft priority list
In spring 2023, we also held webinars with pediatric medical organizations and with pharmacists from across Canada to inform them about the list and encourage their input. Participants were invited to nominate drugs using an online nomination form for a period of 60 days.
Learn more about the Pediatric External Reference Group.
The pediatric drugs that were nominated had to:
- address an area of high unmet need in Canada
- be approved in a select foreign jurisdiction and
- not be currently approved for sale in Canada in the proposed indication or formulation, or both
We received over 900 drug nominations. All therapeutic areas were covered, but most nominations were in the areas of infectious diseases, neurology, hematology and oncology, and cardiovascular diseases.
We screened the nominations to confirm that they met the nomination criteria. Nominated products were screened based on public information about these products because they are not currently approved in Canada. A total of 119 medicinal ingredients in different formats were provided to the external group to review and develop a draft priority list.
The group developed a method for prioritizing the nominated drugs based on several clinical and social factors. To help with this task, the group also sought further input from specialists in various pediatric subspecialities and from pharmacists.
Learn more about the pediatric medical organizations who took part in the webinars.
Next steps
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.
A drug that is on the final National Priority List of Pediatric Drugs does not guarantee that it will receive approval from Health Canada. Any submission received for a drug that is linked to the list will be reviewed for approval based on the information provided in the submission.
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