Canada Health Canada Drug Announcements

Health Canada Implements ICH Pharmaceutical Guidelines

Health Canada is implementing new International Council for Harmonisation (ICH) guidelines for pharmaceuticals, including M13A and Q12/Q14. These implemented ICH guidelines will take precedence over existing Health Canada guidance documents where discrepancies exist, potentially leading to amendments or withdrawals of current guidance.

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.

Health Canada Implements ICH Q12 and Q14 Guidance

Health Canada has announced the implementation of International Council for Harmonisation (ICH) Q12 and Q14 guidance. The initial scope focuses on Post Approval Change Management Protocols (PACMPs) for Biologic and Radiopharmaceutical Drugs Directorate products, with further implementation details to follow.

Health Product Shortages in Canada: 2024-2025 Review

Health Canada has released its review of health product shortages for the 2024-2025 fiscal year. The report details drug and medical device shortages, including reporting requirements for manufacturers and highlights of high-impact cases. It notes a decrease in new drug shortage reports compared to the previous year.

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.