Fees Remission for Public Health Emergency Drugs

Summary#

The federal government issued the Order Amending the Fees in Respect of Drugs and Medical Devices Order (Public Health Emergency Drugs) (SOR/2024-247) to update how drug review fees are handled in certain emergency cases. It lets Health Canada treat fee rules that once applied only to “designated COVID‑19 drug” submissions the same way for broader “public health emergency drug” submissions, and it preserves fee relief for some earlier COVID‑19 submissions. Publication: December 18, 2024 (registration: December 4, 2024).

What it does#

• Changes wording in the Fees in Respect of Drugs and Medical Devices Order so the fee-remission exception that applied to “designated COVID‑19 drug” submissions now applies to “public health emergency drug” submissions.
• Extends that exception to both:
  • new drug submissions that use a rolling-review process, and
  • supplements to new drug submissions that use the same process.
• Keeps the old definition of “designated COVID‑19 drug” working for fee-remission purposes for applications that began under the earlier ISAD interim rules (so those transition cases still get the same relief).
• Sets the order to come into force when the Regulations Amending Certain Regulations Made Under the Food and Drugs Act (Agile Licensing) are published in the Canada Gazette, Part II, or on registration if that happens later.

Who's affected#

• Drug manufacturers and sponsors who submit new drug submissions (NDSs) or supplements for drugs tied to a public health emergency and who use the rolling-review option.
• Sponsors of earlier COVID‑19 drugs that moved from the interim ISAD rules into the Food and Drug Regulations and relied on fee remission.
• Health Canada (as the department applying the fee rules).
• The source says small businesses and treaty/Indigenous obligations were not expected to be affected.

Why it matters#

• Rolling reviews let companies submit information in pieces so regulators can work more quickly during an emergency. But that can stretch the time needed for a full review beyond normal performance targets. This order prevents automatic fee refunds in those cases simply because the standard timelines weren’t met.
• It aligns fee rules with the broader emergency-review approach introduced by Agile Licensing, so emergency drug reviews and related fees are treated consistently going forward.
• It preserves fee relief for certain COVID‑era applications that moved from the interim COVID rules into regular regulations, avoiding an unintended loss of a benefit for those specific applicants.