The Canadian Agency for Drugs and Technologies in Health (CADTH) is requesting stakeholder feedback on its draft guidance document, released today, concerning its recent announcement to introduce industry application fees for manufacturer submissions and resubmissions made to the Common Drug Review.
The draft Guidelines for Manufacturers on Application Fees for the CADTH Common Drug Reviewaddress the following:
- Fees charged for various applications
- Timing of the invoices and how to submit payment
- Payment due dates and implications of late payments
- Performance metric that CADTH will maintain and implications if metric is not achieved
- Conditions where refunds apply
The deadline to submit feedback is August 15, 2014. Final guidelines are expected to be posted by the end of August 2014.
More information and details on how to submit feedback are available on the CADTH website.
Background: CADTH announced the introduction of industry application fees for CDR submissions and resubmissions in May 2014. The fees, meant to help finance an increasing number of CDR reviews by supplementing CADTH’s existing federal, provincial and territorial funding, will be implemented for drugs with a Health Canada Notice of Compliance on or after September 1, 2014. CADTH intends to undertake a review of the fees charged in 2016 and every three years thereafter. Fees will also apply to submissions and resubmissions made to the pan-Canadian Oncology Drug Review (pCODR), effective April 1, 2015.