Canada Introduces Drug User fees

Since September 1, Canada's federal Health Protection Branch has imposed user fees for drug-related premarket approval submission evaluations.

This is the second set of fees to be charged under the HPB's new three-part cost-recovery program, and should produce annual revenues of C$25 million ($18.6 million). The first phase of the program, drug license fees, introduced on january 1, 1995, requires companies to pay an annual fee for each product on the market, and should bring in revenues of up to C$7 million ($5.2 million) a year. The third part of the scheme, covering establishment license fees, will be introduced between next April and January 1, 1997.

The submission evaluation fees will be introduced over a one-year period. The charges are: - C$117,000 basic fee for preclinical and clinical data submissions; - C$52,900 for submissions of clinical data provided in support of additional indications, administration routes and dosages; - C$17,000 for submissions of comparative data for additional indications, administration routes and dosages; and - C$2,700 for bioavailability data for additional drug strengths. In addition, a charge of C$11,500 will be made for submissions of chemical and manufacturing data for the medicinal ingredient under review, and a further C$15,300 fee for submissions for chemical and manufacturing data for each dosage form. There is no additional fee for re-evaluation of all or part of a submission.