Proposed interim approach to speed up the review of certain pediatric drugs: Notice
September 14, 2026
Our file number: 26-104909 - 887
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Purpose
We're looking for feedback on a proposed interim approach to speed up the review of certain pediatric drug submissions.
These include submissions subject to deeming under the Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs.
This new Order took effect on July 15, 2026.
To provide feedback on the proposed interim approach, visit:
Background
We developed the Pediatric Drug Action Plan to help ensure that children and youth in Canada have access to the medicines they need and in age-appropriate formulations.
Through the action plan, we're working with other government departments, external partners and interested parties 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
The Order will help us support these 3 goals. It allows:
- the Minister to rely on decisions or documents from foreign regulatory authorities (FRAs) when reviewing submissions for specific drug classes and
- deeming (or accepting) the requirement to examine sets of information and material in certain drug submissions filed under Part C, Division 8 of the Food and Drug Regulations to be met based on decisions or documents made by FRAs
The Order includes a list that's incorporated by reference. This IbR list sets out the classes of drugs and the FRAs for which deeming can apply.
Learn more:
- Pediatric Drug Action Plan
- The Ministerial Reliance Order: About the Order
- New draft guidance on Ministerial Reliance Order concerning decisions or documents on certain drugs by foreign regulatory authorities: Notice
- List of classes of drugs and foreign regulatory authorities for the purposes of reliance on decisions or documents (IbR List): Human drugs
About the proposed interim approach
In keeping with the policy objectives of the Pediatric Drug Action Plan and the Order, we're proposing an interim approach.
This interim approach will speed up the review process for the following pediatric drug submissions including those seeking both adult and pediatric indications:
- new drug submissions and supplements to new drug submissions for drugs falling within the pediatric-focused classes on the IbR list seeking deeming under the general deeming option of the Order
- other submissions that address areas of unmet pediatric needs in Canada identified on the National Priority List of Pediatric Drugs
We may add or change the criteria as needed and based on the feedback we receive.
Under this interim approach, we plan to review a submission within 180 days. Manufacturers should identify if they meet the criteria in their cover letter when filing their drug submission. All other drug submission requirements would still apply, as well as those related to deeming under the Order.
Eligible drug submissions are subject to existing review performance standards and fee implications. Where it's appropriate, we may issue an interim negative decision following our expedited review.
Note that current policies or processes for the review of human drug submissions will still apply. For example, all drug manufacturers can still request:
- a priority review if they meet the applicable eligibility criteria
- advance consideration under the notice of compliance with conditions (NOC/c) policy
For information on priority review and NOC/c, refer to:
- Guidance for industry - Priority review of drug submissions
- Guidance Document: Notice of compliance with conditions (NOC/c)
For information on human drug submission processes and requirements, refer to:
Contact us
If you have any questions or comments about this notice, email the Bureau of Policy, Science and International Programs, Pharmaceutical Drugs Directorate, at policy_bureau_enquiries@hc-sc.gc.ca.