Last week Health Canada introduced a proposal to update and increase user fees for pharmaceutical and medical device companies. The last time these fees were updated was 2011, and the changes were based on data from 2007. It is hoped that these changes will remove some of the economic burden being picked up by taxpayers due to outdated fees that are charged to the industry. The proposed changes also discuss comparisons with other regulatory bodies, such as the US FDA, the European Medicines Agency, and the Australian Therapeutic Goods Administration.
In addition to the increase in user fees, under this proposal Health Canada would have the authority to withdraw or withhold services or an approval if fees are not paid. All fees would be collected prior to commencing reviews or issuing licenses. The update would also involve attaching performance goals to user fee programs, as the US FDA does. This would mean a 25% rebate of fees for individual applications, licenses, and decisions that are not completed within the performance standard.
Medical Device Fees
The proposal introduces new fee categories for Class II Licence Amendments, as well as Private Label Applications and Amendments. The proposed performance standard would be 15 days. Class IV Medical Device Applications for near patient in vitro diagnostic devices and fee categories for devices that contain human or animal tissue will be eliminated and merged under the Class IV Medical Device Application category. While many fees will be increased, fees associated with MDELs will be decreased to reflect these updated costs.
New fee categories for generic drug labels, disinfectant labels, and label safety updates have been proposed by Health Canada. Each has a proposed performance standard of 120 days. Elimination of the Published Data fee, switching from prescription to over-the-counter fee categories, and revising performance standards are also on the table.
The proposal is open for consultation until January 4th, 2018. If you want to know more about the fee changes or have any questions, please feel free to contact Focal Point Research Inc. We are industry leading OTC Drug, Medical Device, and Health Canada Regulatory Consultants that you can trust to help guide your company in the right direction.