Canada Health Canada Drug Announcements

Health Canada Consults on Antimicrobial Drug CAN-AWaRe Classification

Health Canada has opened a 60-day public consultation on the proposed Canadian Access, Watch, Reserve (CAN-AWaRe) classification framework for antimicrobial drugs for human use. The consultation runs until June 8, 2026, and seeks feedback from healthcare professionals, industry, academia, and public health agencies on the proposed classification of antibacterial drugs. Comments will inform the finalization of the CAN-AWaRe framework.

Phenytoin Sodium Capsules and Chewable Tablets Shortage Notice

Health Canada issued a notice advising that phenytoin sodium capsules and chewable tablets are in short supply until early May 2026. BGP Pharma's Dilantin products and AA Pharma's capsules are constrained, with Taro's oral suspension unable to compensate. Health Canada is coordinating with provincial and territorial governments and stakeholders to manage the shortage.

Health Canada Task Force on Pharmaceutical Access and Innovation

Health Canada and Innovation, Science and Economic Development Canada have launched a joint Pharmaceutical and Life Sciences Sector Task Force. The task force will support access to pharmaceuticals and identify solutions to drive innovation and growth in the Canadian life sciences sector.

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.

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 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.

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 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.