Health Canada this week opened for consultation a proposal to update and increase some of the fees it assesses for pharmaceutical and medical device companies, noting that the last update came in 2011 and was based on 2007 data.
In addition to increasing some fees significantly (see more below on some of the changes), the proposal would also give new authority to Health Canada to withdraw or withhold service or approval if a fee is not paid, and all fees moving forward would be collected before reviews begins or licenses are issued.
“While Health Canada has remained internationally competitive in meeting performance standards, taxpayers are assuming an increasing economic burden because of outdated fees charged to industry,” the proposal says.
The changes noted in the proposal feature comparisons with the US Food and Drug Administration (FDA), the European Medicines Agency and Australia’s Therapeutic Goods Administration.
And like with FDA performance goals attached to their user fee programs, Health Canada is proposing that as part of its update, “All individual applications/licences/decisions that are not completed within the established performance standard would be rebated 25% of the fee.”
Specifically for medical devices, Health Canada proposes to introduce new fee categories for Class II Licence Amendments and Private Label Applications and Amendments with appropriate performance standards, as the agency says the current costs of the significant workload are not being recovered. The new service standard will be 15 days.
The regulator is also proposing to eliminate Class IV Medical Device Applications for near patient in vitro diagnostic devices or for devices that contain human or animal tissue fee categories, as these applications will be merged under the Class IV Medical Device Application category.
In terms of some of the increased fees, Class III license application fees will more than double from $5,691 to $13,861. Class IV license application fees will also increase to $30,063 (from a range of $12,347 to $22,560) and changes in manufacturing and significant change application fees will also increase from $1,433 to $7,584 and $6,073 to $15,907, respectively.
In addition, it is proposed that fees associated with the Medical Device Establishment Licencing will be decreased (from $8,109 to $4,500) to reflect updated costs.
On the pharmaceuticals side, Health Canada is proposing to introduce new fee categories for generic drug labels, disinfectant labels and label safety updates (each with a 120-day standard).
The regulator is also proposing to eliminate the Published Data fee and the switch from prescription to over-the-counter fee categories and revise performance standards for “Labelling Only Div. 1 (180 days to 120 days); Div.8 (60 days to 120 days) and DINA Labelling Standard (45 days to 60 days).
In terms of some of the fee increases, the proposal notes:
- Submissions in support of a drug, excluding a disinfectant, that contains a medicinal ingredient not previously approved in a drug for sale in Canada and that is not a variation of a previously approved medicinal ingredient: From $341,770 to $603,619.
- Submissions based on clinical or non-clinical data and chemistry and manufacturing data for a drug that does not include a new active substance: From $173,106 to $312,562.
- Submissions based only on clinical or non-clinical data for a drug that does not include a new active substance: From $80,794 to $124,979.
To see all of the fee changes for medical devices, pharmaceuticals and veterinary drugs, see the consultation below. Comments are due 4 January 2018.