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Bioequivalence Requirements in Various Global Jurisdictions pp 21–57Cite as

Canada

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Part of the book series: AAPS Advances in the Pharmaceutical Sciences Series ((AAPS,volume 28))

Abstract

Canadian regulatory authorities were the first to apply pharmacokinetics (PK) to safety and efficacy risk assessment of generic drug products following the 1969 amendments to the Patent Act [1] (compulsory licensing). Formal guidelines were subsequently developed in the 1990s by an Expert Advisory Committee (EAC) where the latest name iteration is the Scientific Advisory Committee (SAC) on Pharmaceutical Sciences and Clinical Pharmacology (SAC-PSCP) which continues to provide advice towards producing several interim guidances and policies into the new millennium. In May 2012, revised guidelines were published [2, 3] and subsequently in May 2014, another guidance document entitled Biopharmaceutics Classification System Based Biowaiver [4] was released where its purpose was to provide guidance to sponsors with the information necessary to apply for a waiver from submitting comparative bioavailability studies. The information required applies only to Biopharmaceutics Classification System (BCS) Class I and III drugs. Review and incorporation of the foregoing guidances are the main changes since the earlier chapter [5].

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Authors and Affiliations

  1. McGilveray Pharmacon Inc., Mississauga, ON, Canada

    Iain J. McGilveray

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  1. Iain J. McGilveray
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Correspondence to Iain J. McGilveray .

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  1. Faculty of Pharmacy, Rhodes University, Grahamstown, South Africa

    Isadore Kanfer

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McGilveray, I.J. (2017). Canada. In: Kanfer, I. (eds) Bioequivalence Requirements in Various Global Jurisdictions. AAPS Advances in the Pharmaceutical Sciences Series, vol 28. Springer, Cham. https://doi.org/10.1007/978-3-319-68078-1_2

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