Cost Recovery Renewal Initiative
Health Canada's cost recovery framework for fees set under the Food and Drugs Act 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)
Health Canada has been charging fees to industry to recover partial costs since 1995. Fees for veterinary drugs had not been updated since that time, human drugs and medical device fees were last updated in April 2011 Fees in Respect of Drugs and Medical Devices Regulations.
In 2017 Health Canada began engaging stakeholders to revise fees for regulatory activities related to human drugs, veterinary drugs, and medical devices. The Fee Proposal for the Drugs and Medical Devices was published for a 75 day consultation period in October 2017 and closed 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.
The revised fees will be implemented April 1, 2020. The Final Fee Report summarizes stakeholder comments from throughout the consultation, along with Health Canada's responses and the final revised fees and performance standards. Reduced fees for small business and in the interest of public health are included. The Performance Standards for the Fees in Respect of Drugs and Medical Devices Order outlines the performance standards to be used to determine whether a remission should be granted for a missed performance standard effective April 1, 2020.
Additional fee proposals to introduce new fees for new regulatory pathways or to revise existing fees will be posted here.
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