On September 14, 2026, Health Canada launched a consultation seeking public feedback on a proposed “new interim approach to speed up the review of certain pediatric drugs”, including on the proposed eligibility criteria and review timelines.
The interim approach proposes to accelerate the review process for pediatric drug submissions, reducing the review timeline to within 180 days, aligning with the review timeline for submissions granted priority review status. In contrast, for example, Health Canada’s review timeline for new drug submissions (NDSs) for new active substances is 300 days.
The following pediatric drug submissions are eligible for review:
- NDSs and supplements to NDSs for drugs falling within the pediatric-focused classes on the Incorporated by Reference List (IbR List) seeking deeming under the general deeming option of the Reliance Order; and
- other submissions that address areas of unmet pediatric needs in Canada identified on the National Priority List of Pediatric Drugs.
In order to determine which submissions fall within the pediatric-focused classes, Health Canada has provided guidance on the interpretation of the IbR List for pediatric-focused drug classes.
The consultation closes on October 23, 2026.
Should you have any questions, please do not hesitate to contact a member of the Life Sciences Regulatory & Compliance Group or the Pharmaceutical Litigation Group.
The preceding is intended as a timely update on Canadian intellectual property and life sciences regulatory law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.