CADTH will be implementing an application fee for manufacturer applications filed with the pan-Canadian Oncology Drug Review (pCODR). The proposed fee will apply to 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. The proposed application fee will also apply to applications of submission or resubmission of cancer drugs with new indications with no pending NOC received on or after April 1, 2015.
The proposed fee will supplement existing provincial and territorial funding and will be used to off-set some of the costs of drug reviews and help finance an increase in the number of cancer drugs that are reviewed by CADTH on an annual basis.
CADTH encourages all interested parties to provide feedback on the draft Guidelines for Manufacturers on Application Fees for the pan-Canadian Oncology Drug Review and to submit comments by e-mail to email@example.com by March 26, 2015.