On May 3, 2019, two sets of proposed amendments to the Food and Drug Regulations were published:
- Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Sale of a New Drug for Emergency Treatment)
- Regulations Amending Certain Regulations Concerning the Sale of Drugs (Public or Canadian Armed Forces Health Emergencies)
The proposed amendments contain provisions which would streamline the process for providing access to unauthorized drugs for medical emergencies. Access to the drugs will continue to be facilitated through the Special Access Program (SAP) for human drugs, and the Emergency Drug Release Program (EDR) for veterinary products. There are currently approximately 500 drugs with active status on the SAP and 45 in the EDR.
The Regulations are meant to facilitate access in the following circumstances:
- Sale of a new drug for emergency treatment: The proposed amendments would remove the requirement for physicians to provide full use, safety and efficacy data when certain conditions are met, including previous SAP/EDR approval for the same medical emergency, and if the drug is authorized for sale without terms and conditions by the European Medicines Agency or the US FDA for the same medical emergency. Further, they would permit “pre-positioning”, i.e. a manufacturer would be able to submit a request for a letter of authorization allowing the import by a drug establishment licence (DEL) holder, for storage until a letter of authorization permits sale.
- Use by a public health official to address a public or military health emergency: The proposed amendments would allow the Minister to authorize the sale of drugs to a public health official, either for immediate use to address an emergency, or in anticipation of a future emergency, consistent with other jurisdictions such as the US, the EU or Australia.
Health Canada Guidance
Health Canada also released accompanying draft Guidance Documents:
- Draft Guidance Document for Industry and Practitioners on the Special Access Program (SAP) for Drugs
- Draft Guidance Document: Public or Canadian Armed Forces Health Emergencies - Drugs for Immediate Use or Stockpiling
Comments on the proposed amendments and the draft Guidance Documents may be submitted until July 19, 2019.
If you have any questions or would like further information, please contact a member of our Pharmaceutical and Life Sciences group.
The preceding is intended as a timely update on Canadian intellectual property and technology law. The content is informational only and does not constitute legal or professional advice. To obtain such advice, please communicate with our offices directly.
Related Publications & Articles
-
Health Canada seeks input on new draft guidance for co-packaged drug products
On March 18, 2025, Health Canada released a Notice that it is seeking feedback on a draft guidance on co-packaged drug products.Read More -
Canada’s Drug Agency releases 2025 Watch List highlighting AI technologies in health care
On March 25, 2025, Canada’s Drug Agency published its annual Watch List, which identifies technologies with the most potential to transform health systems and shape the future of health care in Canada...Read More -
Health Canada publishes Guide to the precision regulating authorities under the Food and Drugs Act
In March 2025, Health Canada published a Guide to the precision regulating authorities under the Food and Drugs Act.Read More