Cost Recovery Renewal Initiative
Health Canada's cost recovery framework for fees set under the Food and Drugs Act (FDA) follows a principled approach to fees that is agile and responsive to a changing regulatory landscape. A key pillar of the framework is Health Canada's commitment to accountability, transparency and stakeholder engagement. This includes public and parliamentary reporting (financial and performance levels), financial penalties for missed performance standards, and meaningful stakeholder consultations when fees are revised.
Revised Fees under the Food and Drugs Act (2020)
Since 1995, Health Canada has been charging fees to industry to partially recover the costs associated with some regulatory activities. Human drugs 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.
In 2017, 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, the Fee Proposal for Drugs and Medical Devices was published in October 2017 for a 75 day consultation period which closed on January 4, 2018. After analyzing all the comments received from stakeholders, Health Canada developed a Revised Fee Proposal for Drugs and Medical Devices in May 2018 and accepted stakeholder feedback until June 14, 2018.
In May 2019, Health Canada published its Final Report: Fees for Drugs and Medical Devices that includes a summary of consultations (including stakeholders' views and Health Canada's responses), revised fees and performance standards.
Revised fees were implemented under the Fees in Respect of Drugs and Medical Devices Order as of April 1, 2020. Modified performance standards, used to determine whether a remission should be granted for a missed performance standard, were also implemented April 1, 2020 under the Performance Standards for the Fees in Respect of Drugs and Medical Devices Order.
An amendment to the Fees Order was implemented in March 2021 to reflect a new remission provision for COVID-19 drugs that transition to the Food and Drug Regulations.
Additional fee proposals to introduce new fees for new regulatory pathways or to revise existing fees will be posted here.
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