Health products cost recovery initiatives

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Our approach to fees

Health Canada's approach to cost recovery regimes for health products is guided by the principles of:

  • accountability and transparency
  • predictability and sustainability
  • stewardship and fairness

This includes public and parliamentary reporting (financial and performance levels), financial penalties for missed performance standards and meaningful stakeholder consultations when fees are revised.

For more information on Health Canada's approach to cost recovery, please visit Cost recovery and fees for Health Canada.

History of fees for health products

Since 1995, Health Canada has been charging fees to industry to partially recover the costs associated with some regulatory activities.

Human drug and medical device fees were previously updated in April 2011 under the Fees in Respect of Drugs and Medical Devices Regulations. Fees for veterinary drugs were not updated at that time.

The Budget Implementation Act of 2017 provided the Minister of Health with the authorities to fix and adjust fees in the Food and Drugs Act (FDA). Later that year, Health Canada began engaging with stakeholders to revise fees for regulatory activities related to human drugs, veterinary drugs and medical devices. As part of the stakeholder engagement process, we proposed revised fees in October 2017. The consultation period closed in January 2018. We reviewed the comments we received and published a revised fee proposal in May 2018. Following stakeholders' comments, we published a final fee report in May 2019.

The Final Report: Fees for Drugs and Medical Devices summarizes the results of the stakeholder consultation, revised fees and performance standards for drugs and medical devices.

Revised fees were implemented under the Fees in Respect of Drugs and Medical Devices Order (Fees Order) on April 1, 2020.

Modified performance standards were also implemented on this date under the Performance Standards for the Fees in Respect of Drugs and Medical Devices Order.

The Fees Order has been recently amended as follows:

Consultation and engagement

Annual cost-recovery stakeholder meeting

Health Canada publishes a report on fees every fall. We then hold a meeting with stakeholders to present costs, revenues and performance for health products that fall under the cost-recovery initiative. We also develop a "what was heard" report, which is available upon request.

Fee consultations

Health Canada held the following consultations with respect to fee proposals and amendments to the Fees Order:

Contact us

If you have a question about the cost-recovery program for health products, please contact the Cost Recovery Policy Office by email at

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