Canada’s Ministerial Order for Reliance on decisions by foreign regulatory agencies for certain drugs: will it benefit pediatric patients?

Abstract

The lack of pediatric indications and age-appropriate formulations in Canada has been a major concern for the pediatric community for decades. Although small patient populations and onerous approval processes may deter drug manufacturers from developing or marketing these drugs and formulations, the lack of adequate incentives may also contribute to the problem. In July, 2026, Canada issued a Ministerial Order allowing certain drugs to be approved by relying on reviews conducted by foreign regulatory agencies, with pediatric drugs selected as the first pilot category. Reviews of literature, media publications, guidance documents, government, particularly regulatory documents and product information were conducted to explore Canada’s historical record of pediatric approvals with comparison to US and EU. Problems associated with lack of pediatric medications in Canada were identified. The Ministerial Order of Reliance together with the guidance document were examined to determine whether the proposed reform will solve the pediatric medication crisis in Canada. The Reliance Order may help to alleviate some regulatory nuance and speed up approval times, however, is this sufficient to compel sponsors to submit with no mandatory requirements or added incentives under the current proposal. The submission fee and labour involved probably will outweigh commercial return in most cases, thus not an attractive option for sponsors, leading to unsuccessful outcomes. The manuscript attempts to identify gaps and provide recommendations to ensure the amended policy and new guidance will be enabling to achieve the desired outcomes.