A policy analysis warns that Canada’s new reliance pathway for drug approvals may not solve pediatric drug shortages. The authors argue the ministerial order allowing reliance on foreign regulatory decisions could speed approvals, but may miss the mandatory requirements and incentive structure that previously improved pediatric access in the US and Europe. For biotech companies, the practical implication is that faster review alone may not translate into pediatric supply if obligations around formulation development, timelines, and guaranteed access are insufficient. The analysis also points to the need for safeguards that specifically address pediatric unmet needs rather than extending adult-oriented reliance processes. The report frames regulatory design as a determinant of real-world availability, not only a question of review speed.
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