As was announced in May 2014, CADTH will be implementing an application fee for manufacturer applications filed with the CADTH pan-Canadian Oncology Drug Review (pCODR).
It is proposed that all manufacturer applications with a Health Canada Notice of Compliance (NOC) or Notice of Compliance with conditions (NOC/c) date of April 1, 2015 or later will be subject to a fee. Similarly, the proposed application fee will apply to an application of a submission or resubmission of cancer drugs with new indications, with no pending NOC (i.e., the indication is not likely to be submitted to Health Canada for review) received on or after April 1, 2015.
The fee was mandated by the Conference of Deputy Ministers of Health and will supplement existing provincial and territorial funding. The fees will be used to offset some of the costs of a drug review and help finance an increase in the number of cancer drugs that are reviewed by CADTH on an annual basis.
We are inviting all interested parties to provide feedback on the draft Guidelines for Manufacturers on Application Fees for the pan-Canadian Oncology Drug Review. We have included a list of FAQs to provide some guidance on the proposed application fee structure for a review through the pCODR process.
Please submit your written comments by email to email@example.com by Thursday, March 26, 2015. All feedback submitted by the deadline will be carefully considered and used to inform the final guidelines.
If you haven't already, please consider subscribing to our CADTH E-Alert system to ensure you receive updates on the pCODR application fees, as well as other CADTH news.