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 | Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs — Order Providing for | SOR/2026-162 |
| I | Proposed |
Amends: Food and Drugs Act↗
Other bills touching same statute
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| Canadian Food Inspection Agency |
| II | Regulation | Department of Health Regulations (Miscellaneous Program) — Regulations Amending Certain | SOR/2026-113 |
| II | Regulation | Food and Drugs Act (Shortages and Discontinuation of Sale of Drugs and Medical Devices) — Regulations Amending Certain Regulations Made Under the | SOR/2026-96 |
| II | Regulation | Medical Devices Regulations (Establishment Licences) — Regulations Amending the | SOR/2026-110 |
| II | Regulation | Foods for a Special Dietary Purpose — Exemption Order in Respect of | 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 | Food and Drugs Act and the Controlled Drugs and Substances Act (Controlled Substances) — Regulations Amending Certain Regulations Made Under the | SOR/2025-246 |
| II | Regulation | Supplementary Rules Respecting the Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine — Order Repealing the Order Establishing | SOR/2025-264 |
| II | Regulation | Foods for a Special Dietary Purpose — Exemption Order in Respect of | 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 | Labelling Requirements for Certain Natural Health Products — Exemption Order in Respect of | SOR/2025-94 |
| II | Regulation | Sale of Natural Health Products Containing Ephedrine or Pseudoephedrine — Order Establishing Supplementary Rules Respecting the | SOR/2025-93 |
| II | Regulation | Cannabis (Streamlining of Requirements) — Regulations Amending Certain Regulations Concerning | SOR/2025-43 |
| II | Regulation | Marketing Authorizations Issued Under the Food and Drugs Act — Order Repealing Certain | SOR/2025-14 |
| II | Regulation | Nicotine Replacement Therapies Order — Order Amending the Supplementary Rules Respecting | 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 | Fees in Respect of Drugs and Medical Devices Order (Public Health Emergency Drugs) — Order Amending the | SOR/2024-247 |
| II | Regulation | Food Additives and Compositional Standards, Microbiological Criteria and Methods of Analysis for Food — Regulations Amending Certain Regulations Concerning | SOR/2024-244 |
| II | Regulation | Food and Drugs Act (Agile Licensing) — Regulations Amending Certain Regulations Made Under the | SOR/2024-238 |
| II | Regulation | Nicotine Replacement Therapies Order — Supplementary Rules Respecting | SOR/2024-169 |
| II | Regulation | Feeds Regulations, 2024 | SOR/2024-132 |
| II | Regulation | Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing) — Regulations Amending the | SOR/2024-136 |
| II | Regulation | Biocides Regulations | SOR/2024-110 |
| II | Regulation | Fees in Respect of Drugs and Medical Devices Order (Biocides) — Order Amending the | SOR/2024-121 |
| I | Proposed | Regulations Amending Certain Regulations Concerning Cannabis (Streamlining of Requirements) | Health, Dept. of |
| II | Regulation | Vitamin D in Yogurt and Kefir — Marketing Authorization for | SOR/2024-88 |
| I | Proposed | Regulations Amending Certain Regulations Concerning Controlled Substances | Health, Dept. of |
| II | Regulation | Disclosure of Cosmetic Ingredients — Regulations Amending Certain Regulations Concerning the | SOR/2024-63 |
| II | Regulation | Fees in Respect of Drugs and Medical Devices Order (Medical Devices for an Urgent Public Health Need) — Order Amending the | SOR/2023-278 |
| II | Regulation | Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) — Regulations Amending the | SOR/2023-277 |
| II | Regulation | Health Regulations (Miscellaneous Program) — Regulations Amending Certain Department of | 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 | Fees in Respect of Drugs and Medical Devices Order (COVID-19 Medical Devices) — Order Amending the | SOR/2023-21 |
| II | Regulation | Medical Devices Regulations (Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19) — Regulations Amending the | SOR/2023-19 |
| II | Regulation | Sale of Drugs (Public or Canadian Armed Forces Health Emergencies) — Regulations Amending Certain Regulations Concerning the | SOR/2023-18 |
| I | Proposed | Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients (New commenting feature) | Health, Dept. of |
| II | Regulation | Cannabis Research and Testing and Cannabis Beverages — Regulations Amending Certain Regulations Concerning | 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 | Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils) — Regulations Amending the | SOR/2022-168 |
| II | Regulation | Department of Health Regulations (Miscellaneous Program) — Regulations Amending Certain | SOR/2022-197 |
| II | Regulation | Natural Health Products Regulations — Regulations Amending the | SOR/2022-146 |
| II | Regulation | Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods) — Regulations Amending the | SOR/2022-169 |
| II | Regulation | Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils) — Regulations Amending the | SOR/2022-168 |
| II | Regulation | Food and Drug Regulations — Regulations Amending the | SOR/2022-143 |
| II | Regulation | Natural Health Products Regulations — Regulations Amending the | SOR/2022-146 |
| II | Regulation | Food and Drug Regulations (Exports and Transhipments of Drugs) — Regulations Amending the | 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 | Vitamin D in Milk, Goat’s Milk and Margarine — Marketing Authorization for | SOR/2021-278 |
| II | Regulation | Establishment Licence Fees Remission Order (Indication of an Activity in respect of a COVID-19 Drug) — Order Repealing the | SOR/2021-274 |
| II | Regulation | Restricted Drugs (Special Access Program) — Regulations Amending Certain Regulations Relating to | SOR/2021-271 |
| II | Regulation | Drugs and Medical Devices (Shortages) — Regulations Amending Certain Regulations Concerning | SOR/2021-199 |
| II | Regulation | Food and Drugs Act (Food Enzymes and Preservatives) — Marketing Authorization Amending Certain Marketing Authorizations Issued Under the | 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 | Food and Drug Regulations (Human Milk Fortifiers) — Regulations Amending the | SOR/2021-57 |
| II | Regulation | Department of Health Regulations (Miscellaneous Program) — Regulations Amending Certain | SOR/2021-46 |
| II | Regulation | Fees in Respect of Drugs and Medical Devices Order (COVID-19 Drugs) — Order Amending the | SOR/2021-47 |
| II | Regulation | Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19) — Regulations Amending the | SOR/2021-45 |
| II | Regulation | Food and Drug Regulations and the Medical Devices Regulations (Post-market Surveillance of Medical Devices) — Regulations Amending the | 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 | Food and Drugs Act (Sale of a New Drug for Emergency Treatment) — Regulations Amending Certain Regulations Made Under the | SOR/2020-212 |
| II | Regulation | Food and Drug Regulations (Distribution of Drugs as Samples) — Regulations Amending the | SOR/2020-74 |
| II | Regulation | Food and Drug Regulations (Finished Product Testing) — Regulations Amending the | SOR/2020-73 |
| II | Regulation | Natural Health Products Regulations (Distribution of Natural Health Products as Samples) — Regulations Amending the | SOR/2020-75 |
| II | Regulation | Certain Marketing Authorizations Issued Under the Food and Drugs Act — Marketing Authorization Amending | SOR/2019-210 |
| II | Regulation | Food and Drug Regulations (Serious Adverse Drug Reaction Reporting — Hospitals) — Regulations Amending | SOR/2019-190 |
| II | Regulation | Food and Drug Regulations (Vodka) — Regulations Amending | SOR/2019-217 |
| II | Regulation | Medical Devices Regulations (Medical Device Incident Reporting — Hospitals) — Regulations Amending | 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 | Benzodiazepines and Other Targeted Substances Regulations (Licences and Permits) — Regulations Amending | SOR/2019-170 |
| II | Regulation | Food and Drug Regulations (Parts G and J — Licences and Permits) — Regulations Amending | SOR/2019-171 |
| II | Regulation | Fees in Respect of Drugs and Medical Devices Order | SOR/2019-124 |
| II | Regulation | Food and Drug Regulations (Flavoured Purified Alcohol) — Regulations Amending | 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 | Food and Drug Regulations (Beer) — Regulations Amending | SOR/2019-98 |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Improving Access to Generics) | Health, Dept. of |
| II | Regulation | Food and Drug Regulations (Public Release of Clinical Information) — Regulations Amending | SOR/2019-62 |
| II | Regulation | Medical Devices Regulations (Public Release of Clinical Information) — Regulations Amending | SOR/2019-63 |
| II | Regulation | Medical Devices Regulations (Updating ISO Standard) — Regulations Amending | SOR/2019-44 |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Flavoured Purified Alcohol) | Health, Dept. of |
| II | Regulation | Food and Drug Regulations (Mica) — Regulations Amending | SOR/2018-248 |
| II | Regulation | Medical Devices Regulations (Importation) — Regulations Amending | SOR/2018-225 |
| II | Regulation | Cannabis Regulations | SOR/2018-144 |
| II | Regulation | Food and Drug Regulations and the Natural Health Products Regulations (Vaping Products) — Regulations Amending | 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 | Food and Drug Regulations (Opioids) — Regulations Amending | SOR/2018-77 |
| II | Regulation | Certain Department of Health Regulations (Miscellaneous Program) — Regulations Amending | 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 | Food and Drug Regulations (DIN Requirements for Drugs Listed in Schedule C to the Food and Drugs Act that are in Dosage Form) — Regulations Amending | 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 | Food and Drug Regulations (Importation of Drugs for an Urgent Public Health Need) — Regulations Amending | SOR/2017-133 |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Opioids) | Health, Dept. of |
| II | Regulation | Food and Drug Regulations (Veterinary Drugs — Antimicrobial Resistance) — Regulations Amending | 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 | Certain Department of Health Regulations (Miscellaneous Program) — Regulations Amending | SOR/2017-18 |
| II | Regulation | Food and Drug Regulations (Food Irradiation) — Regulations Amending | SOR/2017-16 |
| II | Regulation | Food and Drug Regulations (Nutrition Labelling, Other Labelling Provisions and Food Colours) — Regulations Amending | 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 | Food and Drug Regulations (Food Additives) — Regulations Amending | SOR/2016-143 |
| II | Regulation | Food and Drug Regulations (Shortages of Drugs and Discontinuation of Sale of Drugs) — Regulations Amending | SOR/2016-139 |
| I | Proposed | Regulations Amending the Food and Drug Regulations (Food Irradiation) | Health, Dept. of |
| II | Regulation | Food and Drug Regulations (Food — Various Subjects) — Regulations Amending | SOR/2016-74 |
Canada Gazette activity is tracked from January 2025 onward — regulations made before 2025 are not shown.