This enactment amends the Food and Drugs Act to establish a list of therapeutic products pre-approved for special access to allow streamlined access to treatment for patients with serious or life-threatening conditions or where there is an unmet need. It also provides parameters to guide the Minister of Health in issuing letters of authorization for the sale of new drugs for emergency treatment under the Food and Drug Regulations.
House First Reading
Second reading and referral to committee
House Second Reading
| Part | Type | Title | Instrument / Sponsor |
|---|---|---|---|
| II | Regulation | Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs | SOR/2026-162 |
| I | Proposed |
Amends: Food and Drugs Act↗
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| Canadian Food Inspection Agency |
| II | Regulation | Regulations Amending Certain Department of Health Regulations (Miscellaneous Program) | SOR/2026-113 |
| II | Regulation | Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices) | SOR/2026-96 |
| II | Regulation | Regulations Amending the Medical Devices Regulations (Establishment Licences) | SOR/2026-110 |
| II | Regulation | Exemption Order in Respect of Foods for a Special Dietary Purpose | SOR/2025-248 |
| I | Proposed | Clinical Trials Regulations | Health, Dept. of |
| I | Proposed | Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs | Health, Dept. of |
| I | Proposed | Regulations Amending Certain Regulations Relating to Clinical Trials | Health, Dept. of |
| II | Regulation | Regulations Amending Certain Regulations Made Under the Food and Drugs Act and the Controlled Drugs and Substances Act (Controlled Substances) | SOR/2025-246 |
| II | Regulation | Order Repealing the Order Establishing Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine | SOR/2025-264 |
| II | Regulation | Exemption Order in Respect of Foods for a Special Dietary Purpose | SOR/2025-248 |
| I | Proposed | Regulations Amending the Medical Devices Regulations (Establishment Licences) | Health, Dept. of |
| I | Proposed | Order Repealing the Order Establishing Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine | Health, Dept. of |
| II | Regulation | Exemption Order in Respect of Labelling Requirements for Certain Natural Health Products | SOR/2025-94 |
| II | Regulation | Order Establishing Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine | SOR/2025-93 |
| II | Regulation | Regulations Amending Certain Regulations Concerning Cannabis (Streamlining of Requirements) | SOR/2025-43 |
| II | Regulation | Order Repealing Certain Marketing Authorizations Issued Under the Food and Drugs Act | SOR/2025-14 |
| II | Regulation | Order Amending the Supplementary Rules Respecting Nicotine Replacement Therapies Order | SOR/2025-9 |
| I | Proposed | Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices) | Health, Dept. of |
| II | Regulation | Order Amending the Fees in Respect of Drugs and Medical Devices Order (Public Health Emergency Drugs) | SOR/2024-247 |
| II | Regulation | Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food | SOR/2024-244 |
| II | Regulation | Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) | SOR/2024-238 |
| II | Regulation | Supplementary Rules Respecting Nicotine Replacement Therapies Order | SOR/2024-169 |
| II | Regulation | Feeds Regulations, 2024 | SOR/2024-132 |
| II | Regulation | Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing) | SOR/2024-136 |
| II | Regulation | Biocides Regulations | SOR/2024-110 |
| II | Regulation | Order Amending the Fees in Respect of Drugs and Medical Devices Order (Biocides) | SOR/2024-121 |
| I | Proposed | Regulations Amending Certain Regulations Concerning Cannabis (Streamlining of Requirements) | Health, Dept. of |
| II | Regulation | Marketing Authorization for Vitamin D in Yogurt and Kefir | SOR/2024-88 |
| I | Proposed | Regulations Amending Certain Regulations Concerning Controlled Substances | Health, Dept. of |
| II | Regulation | Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients | SOR/2024-63 |
| II | Regulation | Order Amending the Fees in Respect of Drugs and Medical Devices Order (Medical Devices for an Urgent Public Health Need) | SOR/2023-278 |
| II | Regulation | Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) | SOR/2023-277 |
| II | Regulation | Regulations Amending Certain Department of Health Regulations (Miscellaneous Program) | SOR/2023-247 |
| I | Proposed | Regulations Amending Certain Regulations Concerning Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food | Health, Dept. of |
| I | Proposed | Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing) | Health, Dept. of |
| II | Regulation | Medical Device Establishment Licence Fees Remission Order (Expedited Examination of Applications During the COVID-19 Pandemic) | SOR/2023-36 |
| II | Regulation | Order Amending the Fees in Respect of Drugs and Medical Devices Order (COVID-19 Medical Devices) | SOR/2023-21 |
| II | Regulation | Regulations Amending the Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) | SOR/2023-19 |
| II | Regulation | Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies) | SOR/2023-18 |
| I | Proposed | Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients (New commenting feature) | Health, Dept. of |
| II | Regulation | Regulations Amending Certain Regulations Concerning Cannabis Research and Testing and Cannabis Beverages | SOR/2022-251 |
| I | Proposed | Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) (New commenting feature) | Health, Dept. of |
| II | Regulation | Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils) | SOR/2022-168 |
| II | Regulation | Regulations Amending Certain Department of Health Regulations (Miscellaneous Program) | SOR/2022-197 |
| II | Regulation | Regulations Amending the Natural Health Products Regulations | SOR/2022-146 |
| II | Regulation | Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods) | SOR/2022-169 |
| II | Regulation | Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils) | SOR/2022-168 |
| II | Regulation | Regulations Amending the Food and Drug Regulations | SOR/2022-143 |
| II | Regulation | Regulations Amending the Natural Health Products Regulations | SOR/2022-146 |
| II | Regulation | Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs) | SOR/2022-100 |
| I | Proposed | Biocides Regulations (New commenting feature) | Health, Dept. of |
| I | Proposed | Regulations Amending Certain Regulations Concerning Cannabis Research and Testing and Cannabis Beverages (New commenting feature) | Health, Dept. of |
| II | Regulation | Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations | SOR/2022-18 |
| II | Regulation | Marketing Authorization for Vitamin D in Milk, Goat’s Milk and Margarine | SOR/2021-278 |
| II | Regulation | Order Repealing the Establishment Licence Fees Remission Order (Indication of an Activity in respect of a COVID-19 Drug) | SOR/2021-274 |
| II | Regulation | Regulations Amending Certain Regulations Relating to Restricted Drugs (Special Access Program) | SOR/2021-271 |
| II | Regulation | Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) | SOR/2021-199 |
| II | Regulation | Marketing Authorization Amending Certain Marketing Authorizations Issued Under the Food and Drugs Act (Food Enzymes and Preservatives) | SOR/2021-176 |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Supplemented Foods) | Health, Dept. of |
| I | Proposed | Regulations Amending the Natural Health Products Regulations | Health, Dept. of |
| I | Proposed | Feeds Regulations, 2022 (NEW commenting feature) | Canadian Food Inspection Agency |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Exports and Transhipments of Drugs) (NEW commenting feature) | Health, Dept. of |
| II | Regulation | Regulations Amending the Food and Drug Regulations (Human Milk Fortifiers) | SOR/2021-57 |
| II | Regulation | Regulations Amending Certain Department of Health Regulations (Miscellaneous Program) | SOR/2021-46 |
| II | Regulation | Order Amending the Fees in Respect of Drugs and Medical Devices Order (COVID-19 Drugs) | SOR/2021-47 |
| II | Regulation | Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19) | SOR/2021-45 |
| II | Regulation | Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices) | SOR/2020-262 |
| II | Regulation | Establishment Licence Fees Remission Order (Indication of an Activity in respect of a COVID-19 Drug) | SOR/2020-213 |
| II | Regulation | Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) | SOR/2020-212 |
| II | Regulation | Regulations Amending the Food and Drug Regulations (Distribution of Drugs as Samples) | SOR/2020-74 |
| II | Regulation | Regulations Amending the Food and Drug Regulations (Finished Product Testing) | SOR/2020-73 |
| II | Regulation | Regulations Amending the Natural Health Products Regulations (Distribution of Natural Health Products as Samples) | SOR/2020-75 |
| II | Regulation | Marketing Authorization Amending Certain Marketing Authorizations Issued Under the Food and Drugs Act | SOR/2019-210 |
| II | Regulation | Regulations Amending Food and Drug Regulations (Serious Adverse Drug Reaction Reporting — Hospitals) | SOR/2019-190 |
| II | Regulation | Regulations Amending Food and Drug Regulations (Vodka) | SOR/2019-217 |
| II | Regulation | Regulations Amending Medical Devices Regulations (Medical Device Incident Reporting — Hospitals) | SOR/2019-191 |
| I | Proposed | Regulations Amending the Food and Drug Regulations | Canadian Food Inspection Agency |
| I | Proposed | Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Post-market Surveillance of Medical Devices) | Health, Dept. of |
| II | Regulation | Regulations Amending Benzodiazepines and Other Targeted Substances Regulations (Licences and Permits) | SOR/2019-170 |
| II | Regulation | Regulations Amending Food and Drug Regulations (Parts G and J — Licences and Permits) | SOR/2019-171 |
| II | Regulation | Fees in Respect of Drugs and Medical Devices Order | SOR/2019-124 |
| II | Regulation | Regulations Amending Food and Drug Regulations (Flavoured Purified Alcohol) | SOR/2019-147 |
| I | Proposed | Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment) | Health, Dept. of |
| I | Proposed | Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies) | Health, Dept. of |
| II | Regulation | Regulations Amending Food and Drug Regulations (Beer) | SOR/2019-98 |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Improving Access to Generics) | Health, Dept. of |
| II | Regulation | Regulations Amending Food and Drug Regulations (Public Release of Clinical Information) | SOR/2019-62 |
| II | Regulation | Regulations Amending Medical Devices Regulations (Public Release of Clinical Information) | SOR/2019-63 |
| II | Regulation | Regulations Amending Medical Devices Regulations (Updating ISO Standard) | SOR/2019-44 |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Flavoured Purified Alcohol) | Health, Dept. of |
| II | Regulation | Regulations Amending Food and Drug Regulations (Mica) | SOR/2018-248 |
| II | Regulation | Regulations Amending Medical Devices Regulations (Importation) | SOR/2018-225 |
| II | Regulation | Cannabis Regulations | SOR/2018-144 |
| II | Regulation | Regulations Amending Food and Drug Regulations and the Natural Health Products Regulations (Vaping Products) | SOR/2018-132 |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Beer) | Canadian Food Inspection Agency |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Serious Adverse Drug Reaction Reporting—Hospitals) | Health, Dept. of |
| I | Proposed | Regulations Amending the Medical Devices Regulations (Medical Device Incident Reporting —Hospitals) | Health, Dept. of |
| II | Regulation | Safe Food for Canadians Regulations | SOR/2018-108 |
| II | Regulation | Regulations Amending Food and Drug Regulations (Opioids) | SOR/2018-77 |
| II | Regulation | Regulations Amending Certain Department of Health Regulations (Miscellaneous Program) | SOR/2018-69 |
| I | Proposed | Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Nutrition Symbols, Other Labelling Provisions, Partially Hydrogenated Oils and Vitamin D) | Health, Dept. of |
| II | Regulation | Regulations Amending Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) | SOR/2017-259 |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) | Health, Dept. of |
| I | Proposed | Regulations Amending the Medical Devices Regulations (Public Release of Clinical Information) | Health, Dept. of |
| II | Regulation | Regulations Amending Food and Drug Regulations (Importation of Drugs for an Urgent Public Health Need) | SOR/2017-133 |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Opioids) | Health, Dept. of |
| II | Regulation | Regulations Amending Food and Drug Regulations (Veterinary Drugs — Antimicrobial Resistance) | SOR/2017-76 |
| II | Regulation | Food Additives with Other Generally Accepted Uses — Marketing Authorization Amending the Marketing Authorization | SOR/2017-67 |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Importation of Drugs for an Urgent Public Health Need) | Health, Dept. of |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Vanessa's Law) | Health, Dept. of |
| II | Regulation | Regulations Amending Certain Department of Health Regulations (Miscellaneous Program) | SOR/2017-18 |
| II | Regulation | Regulations Amending Food and Drug Regulations (Food Irradiation) | SOR/2017-16 |
| II | Regulation | Regulations Amending Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours) | SOR/2016-305 |
| II | Regulation | Cannabis Exemption (Food and Drugs Act) Regulations | SOR/2016-231 |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Veterinary Drugs — Antimicrobial Resistance) | Health, Dept. of |
| II | Regulation | Regulations Amending Food and Drug Regulations (Food Additives) | SOR/2016-143 |
| II | Regulation | Regulations Amending Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs) | SOR/2016-139 |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Food Irradiation) | Health, Dept. of |
| II | Regulation | Regulations Amending Food and Drug Regulations (Food — Various Subjects) | SOR/2016-74 |
Canada Gazette activity is tracked from January 2025 onward — regulations made before 2025 are not shown.