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Cells, Tissues and Organs The Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations or Regulations) contain safety requirements with respect to processing; storage; record keeping; distribution; importation; error, accident and adverse…
Blood for transfusion or for use in the manufacture of a drug On this page Who must register or be licensed How to apply for an authorization How to apply for registration How to apply for a blood establishment licence Requirement to report an error or accident Inspections The…
Compliance and Enforcement Policy (POL-0001) From: Regulatory Operations and Enforcement Branch (ROEB) Find the latest results from Canada's drug and health product inspections Report advertising of an unauthorized product See Drug and Medical Device Recalls Criminal Code of…
Compliance and Enforcement RSS Feeds Subscribe to the Really Simple Syndication (RSS) feeds below to obtain links to new and updated information when it is posted online. Compliance and Enforcement RSS Feed Stay informed when new items, such as guidance documents, policies and…
What’s new: Drugs and health products compliance and enforcement Subscribe to our RSS Feeds COVID-19 Medical devices for use in relation to COVID-19 [2023-02-22] Amendments to Medical Devices Regulations to continue importation and sale of COVID-19 medical devices: Notice…
Notice to Stakeholders - Policy Statement on the Naming of Biologic Drugs Health Canada thanks those who responded to the 2018 Consultation on the Naming of Biologic Drugs. A “ What We Heard ” Report summarizing the results of this consultation has been published on the Health…
Regulatory initiatives The Biologic and Radiopharmaceutical Drugs Directorate (BRDD) applies the Food and Drug Regulations under the authority of the Food and Drugs Act to ensure that drugs defined by Schedule C and Schedule D of the Act for human use in Canada are safe,…
Look-Alike Sound-Alike Health Product Names Consultation Look-alike Sound-alike (LA/SA) Health Product Names: Comments and Responses to the Related Guidances [2005-07-25] Look-alike Sound-alike (LA/SA) Health Product Names: Comments and Responses to the Issue as Presented in the…
Applications and Submissions - Biologics, Radiopharmaceuticals and Genetic Therapies - Health Canada All drugs that are marketed in Canada are subject to the Food and Drugs Act and Regulations. The Biologics and Genetic Therapies Directorate is responsible for the review and…
Regulating autologous stem cell products prepared at point-of-care: Summary report On this page About the virtual workshop Opening remarks Clinical trials framework Current and planned regulations for new drugs Clinical trial sponsor perspective FDA perspective Alberta's…
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