On January 26, 2024, Health Canada published a Notice concerning its application of the definition of Canadian Reference Product (CRP) in the Food and Drug Regulations (Regulations). The Notice advises that if an innovative drug is categorized as “Dormant” in Health Canada’s Drug Product Database, then a generic manufacturer can compare its drug against an alternate CRP, which could include another generic drug, when filing an Abbreviated New Drug Submission (ANDS).
Generic approvals: In Canada, generic drugs are typically approved through the ANDS pathway, which requires that a generic drug meet certain criteria in relation to a designated CRP. For instance, the generic drug must be “the pharmaceutical equivalent of the [CRP]” and be “bioequivalent with the [CRP]”.
- By contrast, biosimilar drugs must be approved through a New Drug Submission. Biosimilar drugs are expressly excluded from the January 26, 2024 Notice.
Dormant status: A drug listed as “Dormant” in Health Canada’s Drug Product Database means the drug is not presently being sold in Canada, but has not been withdrawn from the market. For example, “Dormant” status could be triggered by a supply shortage, a manufacturing issue, or by a temporary change in demand.
- A drug is listed as “Dormant” in the Drug Product Database after the manufacturer notifies Health Canada that the drug has not been sold on the Canadian market for 12 consecutive months. The Regulations require manufacturers of certain drugs – including prescription drugs – to provide this notice within 30 calendar days after 12 months without sales have passed.
Health Canada’s use of “Dormant” status when assessing a CRP
The January 26, 2024 Notice applies to applications under the ANDS and Extraordinary Use ANDS pathways.
The Notice confirms Health Canada’s view that a “Dormant” status in the Drug Product Database can be considered evidence that a drug is “no longer marketed” under paragraph C.08.001.1(b) of the Regulations. As a consequence, if an innovative drug is listed as “Dormant”, then a generic manufacturer can file an ANDS comparing its drug to an alternate CRP, provided that the alternate CRP is otherwise acceptable to Health Canada. According to the Notice, the alternate CRP is preferably another generic drug that has demonstrated bioequivalence with the “Dormant” innovative drug.
The Notice also advises that the relevant time for assessing whether the innovative drug is “Dormant” is the time of ANDS filing. Therefore:
- If the innovator restarts sales of a “Dormant” drug after the ANDS is filed, that will not affect Health Canada’s assessment of an alternate CRP in the ANDS.
- If the innovator restarts sales of a “Dormant” drug before the ANDS is filed (even if the Drug Product Database has not yet been updated), Health Canada may ask for the ANDS to be withdrawn and/or may issue a negative decision.
- Health Canada, Notice: Application of the definition of Canadian Reference Product (January 26, 2024)