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Browse and search historical snapshots. This is an archive — not current guidance or medical advice. Archived content may be incomplete, outdated, or superseded. For up-to-date recommendations, always consult the official source website.
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Consultation on proposed agile regulations and guidance for licensing drugs and medical devices Current status: Closed Opened on December 17, 2022, and closed to new input on April 26, 2023, at 11:59 pm Eastern Standard Time (EST). Health Canada is proposing new targeted…
Guidance on the Food and Drug Regulations for public health emergency drugs: Overview This guidance is a draft version for consultation purposes only. It is not to be implemented at this time. Overview Preparing a submission Drug establishment licences, good manufacturing…
Biologic drugs (Schedule D drugs) – Division 4 proposed regulatory amendments: Notice to stakeholders A public consultation on proposed amendments to modify Division 4 in Part C of the Food and Drug Regulations (FDR) for biologic drugs was held from December 2022 to April 2023. A…
Draft guidance document on the collection and analysis of disaggregated data in clinical trials: Overview The next version of this guidance document will be updated to align with the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing)…
Consultation on draft Guidance on the collection and analysis of disaggregated data in clinical trials: Notice to stakeholders The next version of the guidance document will be updated to align with the Regulations Amending Certain Regulations Made Under the Food and Drugs Act…
Draft guidance document on terms and conditions (T&Cs) for human and veterinary drugs This guidance is a first draft and is not to be implemented. A second draft of the Guidance on Terms and Conditions for Human and Veterinary Drugs is now open for consultation . Download in PDF…
Draft guidance on terms and conditions for human and vet drugs: Notice From: Health Canada December 17, 2022 Health Canada published amendments to the Food and Drug Regulations (FDR) in Canada Gazette, Part I , on December 17, 2022. The amendments are entitled "Regulations…
Consultation Summary: Health Products Stakeholder Engagement Session June 27, 2018 Theme and Objectives On June 27, 2018, Health Canada's Health Products and Food Branch (HPFB) welcomed health product stakeholders to an annual stakeholder engagement session. The objective of the…
Notice to Interested Parties - Regulatory amendments regarding pharmacists Current status: Closed The consultation ran from March 9, 2019 to May 7, 2019. You are invited to provide comments on Health Canada's intent to amend the Narcotic Control Regulations (NCR ) , the…
Forward Regulatory Plan From: Health Canada Health Canada's Forward Regulatory Plan for 2025-2027 : is a publicly available list, with descriptions, of planned or anticipated regulatory changes (regulatory initiatives) that Health Canada intends to propose or finalize within a…
Early release: coverage and features are still expanding.
