In May 2023, Health Canada proposed implementing cost recovery fees to enhance regulatory oversight and streamline the approval processes for NHPs. During the initial consultation period, Health Canada received 4,696 comments from submissions and 116 emails, including emails from key industry associations. The submission included stakeholder concerns about the fee amounts and their potential impacts on consumers, businesses, and product innovation. To address the stakeholder’s concerns, Health Canada hosted an engagement session with industry associations on March 27, 2024, to discuss and review the 2nd version of the proposed cost recovery fees for NHPs.

Updates to the proposal include:

  1. Lowered fees by limiting planned program enhancements.
  2. Lowered the fee-setting ratio for the first 4 years.
  3. Phased in fees over a 7-year period (targeting a coming into force date of December 1, 2025).
  4. Removed the proposed Class III-Novel category.
  5. Streamlined the annual site licensing fee categories from 5 fees to 3.

No adjustments have been made to the initial proposed fees for small businesses. The small business discounts from the initial proposal will continue to apply to the new, lower fees:

  1. 100% discount for pre-market evaluation fees for the business’s first-ever NHP submission
  2. 50% discounts for pre-market evaluation fees for all subsequent product submissions
  3. 25% discounts for site licensing fees and the annual right-to-sell fee.

Fees have been significantly lowered based on the feedback received and the outlined program changes. Annual Site licence fees (manufacturing) have been reduced from $40,071 to $9,561 at the end of the 7 years and apply to sterile and non-sterile dosage forms. The Right to Sell (RTS) fee has been reduced from $542 to $317.

The proposal is open for consultation until April 25, 2024. We strongly advise individuals or organizations working with NHPs in Canada to promptly offer feedback and express any concerns they may have regarding the fee proposal through an online comment form.     

Please get in touch with us if you would like to know more about the proposed fee structure and how it may impact your business.