The federal government has introduced changes to the Food and Drug Regulations1 (the "Regulations") including allowing flexible submission filing for public health emergency drugs, and requiring disaggregated data for a new drug submission and a supplement to a new drug submission, under specific circumstances.
Public Health Emergency Drugs
Public health emergency drugs treat conditions listed on the List of Conditions that Threaten Public Health in Canada. Conditions are added to the list if the Minister of Health has grounds to believe the condition presents, or is the result of, a significant risk to public health in Canada and immediate action is required to deal with the risk. Drugs on this list are afforded rolling submissions reviews by Health Canada. Drug manufacturers are permitted to submit incomplete data sets for new drug applications to start the review process. All missing information must be provided within a reasonable time before the Minister of Health can complete the examination and decide on the drug's authorization.
The filing date for a rolling review submission is set once Health Canada deems it complete from an administrative standpoint. This date remains unchanged even if additional information is provided later.
Disaggregated Data Requirements for New Drug Submission and Supplement to a New Drug Submission
The updated Regulations require that if clinical data previously included in an application made to the European Medicines Agency or the United States Food and Drug Administration is broken down by population subgroup, the data must be broken down in the same manner in the new drug submission or supplement to Health Canada.
In addition to the above, more changes to the Regulations will come into force July 1, 2025, January 1, 2026, and April 1, 2027. Stay tuned for further updates.
Footnote
1. Regulations Amending Certain Regulations Made under the Food and Drugs Act (Agile Licensing): SOR 2024-238, online at < www.gazette.gc.ca/rp-pr/p2/2024/2024-12-18/html/sor-dors238-eng.html >.
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