Since the 1990s, Health Canada has been charging user fees to industry to cover a portion of the costs of its regulatory programs for drugs and medical devices. This is common practice amongst international regulators of therapeutic products.
In this section you will find information about the existing fees related to human drugs, medical devices and veterinary products; as well as information about efforts to update some of these fees.
Cost recovery is a federal government policy intended to promote more business-like and equitable management of government programs. The policy stipulates that specific individuals or firms, who benefit directly from or cause government activity should bear some or all of the cost of those activities.
Many of Health Canada's regulatory activities represent a direct benefit to or are triggered by companies selling therapeutic products on the Canadian market; therefore, these activities are considered appropriate for cost recovery.
The current cost recovery regime for human drugs Fees, medical devices Fees and veterinary products Fees covers pre-market review, post-market surveillance, as well as inspection and licensing of regulated establishments.
After many years of consultation and development, Health Canada's Fees in Respect of Drugs and Medical Devices Regulations came into force in April 2011, marking the first update to user fees for activities conducted under the Human Drugs and Medical Devices Programs since the 1990s.This update was required to provide stable funding for the delivery of important regulatory services that benefit both Canadians and industry. When the revised fees were implemented, Health Canada committed to reviewing its fees and costs for services after three years, as well as comparing its service standards to those of similar international regulatory authorities.
The 2014 Review of the Fees in Respect of Drugs and Medical Devices Regulations includes sections on Finances (costing, revenues, and mitigation), Investments and Improvements (what has been accomplished in the three years since revised fees were implemented), Medical Devices and Drug Products (each section discusses product evaluation, compliance and enforcement and post market safety with regards to performance and other analyses), and an International Comparison.
We will continue to analyze drug and medical device activities and fees, with the goal of improving service delivery and developing a modernized cost recovery framework and to reflect the realities of our operating environment.
Regulations published on the Justice Canada website:
Financial Administration Act
Food and Drugs Act