On 3 May 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); and
  • 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 unauthorised drugs for medical emergencies. Access to the drugs will continue to be facilitated through the Special Access Programme for human drugs and the Emergency Drug Release Programme for veterinary products. There are approximately 500 drugs with active status in the Special Access Programme and 45 in the Emergency Drug Release Programme.

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 Special Access Programme and Emergency Drug Release Programme approval for the same medical emergency, and if the drug is authorised for sale without terms and conditions by the European Medicines Agency or the US Food and Drug Administration for the same medical emergency. Further, they would permit pre-positioning, meaning that a manufacturer would be able to submit a request for a letter of authorisation allowing the import by a drug establishment licence holder for storage until a letter of authorisation permits sale.
  • Use by a public health official to address a public or military health emergency – the proposed amendments would allow the minister to authorise 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 (eg, the United States, the European Union or Australia).

Health Canada has released the following accompanying draft guidance documents:

  • the Draft Guidance Document for Industry and Practitioners on the Special Access Programme for Drugs; and
  • the Draft Guidance Document: Public or Canadian Armed Forces Health Emergencies – Drugs for Immediate Use or Stockpiling.

Comments on the proposed regulatory amendments and the draft guidance documents may be submitted until 19 July 2019.

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