Regulatory Open Forum

Hi all,

For anyone who has some experience with generic drugs regulated by Health Canada...

1. Do you know if Health Canada uses therapeutic equivalence (TE) codes or something similar to what the FDA uses in the Orange Book (where "A" codes are considered equivalent to/interchangeable with the reference product and "B" codes are not)?
2. If a company were to submit an ANDS for a generic product based on in vitro comparability testing with a reference product (i.e., not an in vivo bioequivalence study) and the ANDS is then approved, would the generic product in question be considered interchangeable with the reference product?

Thanks!

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Marissa Berry, Ph.D., RAC
Senior Manager, Regulatory Strategy
Durham, NC
United States
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