Why did user fees need to be updated?
Since user fees were established in the 1990s, the costs of doing business have increased. Several factors have affected the way program activities are performed, including the growth and complexity of product submissions, increasing requirements for surveillance and compliance verification. Other countries charge fees for similar services and update their fees, but Canada was alone in not updating its fees to reflect growing costs. Updated fees for human drug and medical device regulatory activities came into effect on April 1, 2011. These updates were required to provide stable funding for the delivery of important regulatory services for Canadians and the industry, such as product reviews, post-market surveillance, and inspections.
