BIOTECanada Consultation on a proposed interim approach to speed up the review of certain pediatric drugs

October 23, 2026

Bureau of Policy, Science and International Programs
Pharmaceutical Drugs Directorate
Health Products and Food Branch
Health Canada

Email: [email protected]

Re. Comments on Consultation on a proposed interim approach to speed up the review of certain pediatric drugs

Dear Health Canada,

On behalf of the two hundred member companies of BIOTECanada, I am writing regarding Health Canada’s Consultation on a proposed interim approach to speed up the review of certain pediatric drugs. BIOTECanada is the national association for Canada’s biotech industry representing a mix of large multinational pharmaceutical companies, early-stage biotech companies of varying sizes, vaccine companies, drug discovery and accelerator organizations, research centers, universities, and investors.

BIOTECanada strongly supports Health Canada’s commitment to advancing and improving access to medicines and red tape reduction, in both the pediatric space and beyond. In response to Health Canada’s request for feedback on the proposed eligibility criteria and review timelines, BIOTECanada offers the following:

• A national priority list of pediatric drugs which address areas of unmet pediatric needs in Canada is mentioned as another avenue by which Sponsors can meet the expedited pathway (in addition to the IbR criteria). However, there are no details as to how/when this list is updated, and what is the process to request a new drug be added to the list (aside from this initial consultation period). To ensure procedural fairness and help future-proof the list, it is recommended that the list should instead contain specific indications which would fulfil the unmet need, rather than specific drugs. This would avoid queries from industry to add additional drugs to the list and overall aligns with the goal to help reduce red tape.
• Review timeline: The proposed 180-day target matches the existing Priority Review target. BIOTECanada recommends that Health Canada (i) confirm that 180 days is a formal performance standard, (ii) publish performance and uptake metrics, and (iii) set out a path to shorter timelines for deemed submissions, consistent with the 60 to 110 days under the MHRA International Recognition Procedure referenced in our September 10, 2026 submission.
• Fees: The notice indicates that eligible submissions remain subject to existing fee implications. Where deeming reduces Health Canada’s review effort, BIOTECanada recommends that cost recovery be reviewed accordingly.
• Scope of the 180-day target: BIOTECanada supports applying the target to submissions that seek both adult and pediatric indications and asks Health Canada to confirm that it applies to the entire submission. Clarification is also requested on whether submissions that address needs on the National Priority List must also seek deeming under the Order.
• Duration of the interim approach: BIOTECanada requests that Health Canada state the intended duration of the interim approach, how it will be evaluated, and its plans to extend the same timeline to other submissions that qualify for deeming.

Health Canada’s proposed approach responds to one of BIOTECanada’s recommendations made in the Pediatric Action Plan, namely providing an incentive through shorter review timelines. While an expedited review timeline for pediatric submissions has the potential to act as an incentive, it will have little impact on the number of pediatric indications and formulations filed in Canada without first addressing the fundamental issue: ensuring that pursuing pediatric indication reimbursement will not create undue financial risk for manufacturers from HTA, payers and pricing regulators. There is a need for a holistic pediatric regulatory framework that aligns HTAs and PTs to ensure that drugs and formulations for pediatric populations are granted specific consideration throughout the patient access pathway. Without addressing this fundamental issue, it is unlikely that an expedited review timeline or any other incentive will have the desired impact on bringing pediatric medicines to Canada. Industry therefore, reiterates the following recommendations previously submitted through BIOTECanada’s response in 2022 to the Pediatric Action Plan for Health Canada’s consideration. The following could potentially increase the development and filing of pediatric indications in Canada, but without addressing the fundamental issue outlined above, are unlikely to result in greater access to these products in Canada:

• Enable early dialogue and engagement with regulators regarding Sponsors’ pediatric development intentions and plans for their products
• Align Canadian regulatory process and timelines for pediatric plans with those of other major jurisdictions (e,g, US, EU)
• Health Canada should establish a streamlined model based on mutual recognition or reliance on pediatric development agreements reached in trusted jurisdictions
• Health Canada should have an openness and flexibility to extrapolating data for pediatric populations, and to allow use of RWE from databases of pediatric usage¹
• Tactics to incentivize Sponsors to increase pediatric drug development could include improving the intellectual property regime related to pediatric drug development by extending pediatric data protection timelines or extending the drug’s patent life.
• Maintain pediatric studies as voluntary and product specific, using incentives, rather than regulatory mandates to encourage development

Lastly, as expressed in our response on the consultation for the Ministerial Reliance Order, BIOTECanada would welcome a meeting with Health Canada to discuss these comments and reiterates its offer to participate in an industry advisory group on implementation of the Order.

References

1. International Council for Harmonisation (ICH) guidance for industry E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population (April 2018) (ICH E11(R1)); E11A Pediatric Extrapolation