Health Canada Proposes Waiver for Bioavailability Studies
Health Canada has released a new draft guidance document proposing to allow the waiver of bioavailability studies in support of marketing authorization applications for immediate-release, solid oral dosage form drug products.
The proposed waiver would be allowed for generics, bridging studies where the formulation is different from that used in pivotal clinical trials, post-approval changes and product line extensions. Waivers would also be granted for studies in support of Drug Identification Number (DIN) applications.
The draft guidance is the result of a workshop held in Ottawa in June of 2011, a survey of the scientific literature and biowaiver approaches used by other regulatory systems based on the Biopharmaceutics Classification System (BCS).
The BCS is a scientific approach designed to predict drug absorption based on the aqueous solubility and intestinal absorptive characteristics of the drug substance, and categorizes drug substances into one of four classes based on these characteristics. If a BCS-based biowaiver is granted and the product subsequently fails a bioequivalence test, this must be reported immediately along with an assessment of the failure.
The comment period closes in 90 days.
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