Guidance on evaluation fees for human drugs and disinfectants: Credit for missed performance standard

Performance for all submissions or applications filed after April 1, 2020 will be tracked individually. Note that performance for all submissions or applications filed before April 1, 2020, will continue to be rigorously monitored and processed in the order in which they’re received.

The Performance Standards for Fees in Respect of Drugs and Medical Devices Order defines the applicable standard for each activity and fee.

Performance standards for drugs may differ for the same fee category depending on whether the drug is regulated under Division 1 or Division 8 of the Food and Drug Regulations. Most standards reflect the time to complete Review 1, Iteration 1, which is "the period from date of acceptance to date of first decision," not including any review clock pauses.

In the event that the review clock has been paused, the duration of the pause will be deducted from the total review time when calculating performance. In other words, the days during which the clock is paused will not count when measuring performance. Please see the guidance document on the management of drug submission and application for more information on pausing the clock during the review period.

If a submission or application is not reviewed within the established performance standard, sponsors will be credited 25% of the fee originally paid. Health Canada will credit the sponsor’s account within 30 days.

The following are not subject to a credit in the event of a missed performance standard:

• submissions or applications that are part of a joint review or reviewed along with a foreign regulatory authority
• applications for medical device combination products
• rolling submissions filed in accordance with subsection C.08.002(2.3) or C.08.003(7) of the Food and Drug Regulations

For administrative and labelling standards submissions, the 25% credit will be applied automatically to the invoice. In other words, an invoice will be issued for 75% of the applicable fee.