Search

Health Canada Proposes Reliance on Foreign Drug Authority Decisions

Health Canada is proposing a new Ministerial Reliance Order (MRO) that would allow the Minister to examine new drug submissions by relying on decisions from foreign regulatory authorities. This initiative is part of a broader Red Tape Review aimed at facilitating earlier drug availability in Canada while maintaining safety and quality standards. A 70-day consultation period is currently underway.

ICH Consultations on Patient Preference, Extractables, and Adaptive Trials

Health Canada announced three International Council for Harmonisation (ICH) draft guidelines are open for public consultation. The consultations cover patient preference studies, extractables and leachables, and adaptive clinical trials, with comment deadlines ranging from November 2025 to April 2026.