Author: Pinky Mazumder
Health Canada's guidance document on the Fees for the Review of Drug Submissions and Applications provides sponsors information concerning the fees associated with the review of submissions. The Guidance Document applies to New drug Submissions, Supplement to New Drug Submissions, Abbreviated New Drug Submissions, Supplement to Abbreviated New Drug Submissions, and Drug Identification Number (DIN) applications. It does not apply to Emergency Use New Drug Submissions, submissions for natural health products, or for submissions for veterinary drug products.
The fee associated with a particular submission is based on a several factors, including its complexity. Importantly, sponsors who have not completed their first fiscal year at the time of filing the submission are eligible for an option to defer the payment for up to two years.
For fees that are less than $10,000, payment must be submitted at the time the submission or supplement is filed. Where the submission or supplement does not progress for review, the sponsor can receive a maximum of 90% remission of the fee paid.
For fees greater than $10,000, payment is not required to be made at the time of filing. Once Health Canada screens the submission and informs the sponsor that the submission can progress for review, the sponsor is required to pay 75% of the fee. The remaining 25% is to be paid upon the completion of the review. If the submission does not move forward for review, the sponsor must only pay 10% of the required fee. If the submission is withdrawn or cancelled before screening is finished, payment of the fee (exceeding $10,000) is not required.
Industry should also be aware of the annual fee increases, which has been set at 2 % per year since April 1st, 2012. Notices are published in Canada Gazette Part I to highlight the revised fees.
A Drug Submissions/Application Fee Form is required for every submission or supplement. For more information on how to complete this form and information on the fees for review of submission, please refer to the guidance link in the References.
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