FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Canada Details New User Fees for Drug Sponsors

May 28, 2019

Health Canada is increasing fees for drug sponsors and will peg ongoing increases to inflation, the agency said in a final report on the planned changes.

Under rules to be phased in over four years from Apr. 1, 2020, drug sponsors will have to pay 75 percent of costs for pre-market evaluations, 67 percent of right to sell applications and 100 percent for establishment licenses, the agency said in its 50-page report.

“Currently, Health Canada fees are not reflective of the costs to deliver its regulatory programs,” the agency said. “New regulatory challenges stemming from increasingly complex submissions; greater risks from counterfeit or contaminated products; and increased volume of products important into Canada means Health Canada must adapt in order to continue maintaining the effective and efficient delivery of its regulatory activities.”

The agency currently recoups about 43 percent of its operating costs through sponsor fees, whereas regulators in Australia and Europe, for instance, recoup all of their costs from sponsor fees.

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