COVID-19 Drug Submission Fee Waiver

Summary#

This order amends the Fees in Respect of Drugs and Medical Devices Order to allow Health Canada to waive (remit) the government fees for the first formal drug submission that transitions a COVID‑19 product from the emergency pathway into the regular approval pathway. The order was registered on March 19, 2021 and published in the Canada Gazette on March 31, 2021.

What it does#

• Clarifies that a medicinal ingredient that was authorized only under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the ISAD Interim Order) is not treated as already approved in Canada for the purpose of deciding if it is a “new active substance.”
• Grants full remission (a 100% fee waiver) of the examination fee for the first submission — a new drug submission (NDS), a supplement to an NDS, or an abbreviated NDS — for a “designated COVID-19 drug” when:
  • the company filed an application under the ISAD Interim Order, and
  • the company subsequently files the submission under the regular Food and Drug Regulations.
• Says the remission applies only to the initial submission to transition the product. Later submissions for that same drug will be charged the usual fees.
• Explains that for “rolling submissions” (where some information is provided later), fees will not be remitted if Health Canada’s performance standards for review times are not met.
• Comes into force on the day the related Regulations Amending the Food and Drug Regulations (Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19) are registered.

Who's affected#

• Primarily pharmaceutical manufacturers who applied under the ISAD Interim Order and want to move their COVID‑19 drugs into the normal approval system.
• Companies that did not file under the ISAD Interim Order are not eligible for this fee remission.
• Health Canada (which will process these submissions and manage the remissions).
• The change is expected to apply to a small number of products — Health Canada estimated 8–12 submissions might use this route.
• The general public may notice the effects indirectly if more COVID‑19 treatments or vaccines become available.

Why it matters#

• It removes a financial barrier for companies that used the emergency ISAD route to get their COVID‑19 products onto the standard regulatory track.
• That could speed the formal approval process for some COVID‑19 drugs and help maintain access once the interim order ends.
• The change does not speed approvals by itself and does not approve any drug — it only affects fees and how a product is treated for fee purposes.
• The remission is limited (only the first transition submission, and subject to performance‑standard conditions for rolling submissions), so ongoing review work and future changes will still incur normal fees.