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)
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Health Canada also released accompanying draft Guidance Documents:
Comments on the proposed regulatory amendments and the draft Guidance Documents may be submitted until July 19, 2019.