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Despite being a country with 10 times less population than the USA or the European region, Health Canada has been instrumental in establishing innovative guidelines and scientific recommendations for Bioequivalence for the last 40 years. Health Canada regulations are unique, and they are at times aligned with those of the European region and at other times with those of the USA. Since the last version of this chapter in 2018, (McGilveray, Canada, 2018, Bioequivalence requirements in various global jurisdictions, Chapter 2. In: Isadore K (ed) AAPS advances in the pharmaceutical sciences series 28. Springer, Cham, pp 21–57. ISBN 978-3-319-68077-4), Health Canada has updated its general BE guideline twice and will soon update it again after the ICH M13 guidelines are approved and implemented. A major change has been the removal for the need for a clinical or pharmacodynamic endpoint study for orally inhaled drug products, and therefore these products can now be approved after device, in vitro, and PK equivalence have been demonstrated between the generic and the Canadian reference product. The last 7 years have also seen the approval of many tyrosine kinase “inib” generic products, which prompted the European Medicines Agency to realize and acknowledge that sometimes a very low proportion of subjects do not show measurable concentrations with the reference products, and thus should not be considered for the BE assessment. This has been implemented in the currently enforced BE guideline, in that “one Subject with very low concentrations may be removed if the AUC for that period is less than 5% of the geometric mean AUC (calculated without the subject) for the product in question”. At the time of writing of this chapter, the ICH M13A guideline had not been yet adopted by Health Canada. However, its adoption is likely to result in two major changes for Immediate Release products. First, some of them will likely in the future necessitate both fed and fasted BE studies, and would be termed “high risk” products. Secondly, metabolites that are active and formed pre-systemically within the gut wall would need to be measured and presented with BE study results, in line with recommendations from the Office of Generic Drugs of the US FDA for almost 20 years.

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Canada

  • 章节

  • 发表日期：

    2025年

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  • Murray P. Ducharme

摘要

Despite being a country with 10 times less population than the USA or the European region, Health Canada has been instrumental in establishing innovative guidelines and scientific recommendations for Bioequivalence for the last 40 years. Health Canada regulations are unique, and they are at times aligned with those of the European region and at other times with those of the USA. Since the last version of this chapter in 2018, (McGilveray, Canada, 2018, Bioequivalence requirements in various global jurisdictions, Chapter 2. In: Isadore K (ed) AAPS advances in the pharmaceutical sciences series 28. Springer, Cham, pp 21–57. ISBN 978-3-319-68077-4), Health Canada has updated its general BE guideline twice and will soon update it again after the ICH M13 guidelines are approved and implemented. A major change has been the removal for the need for a clinical or pharmacodynamic endpoint study for orally inhaled drug products, and therefore these products can now be approved after device, in vitro, and PK equivalence have been demonstrated between the generic and the Canadian reference product. The last 7 years have also seen the approval of many tyrosine kinase “inib” generic products, which prompted the European Medicines Agency to realize and acknowledge that sometimes a very low proportion of subjects do not show measurable concentrations with the reference products, and thus should not be considered for the BE assessment. This has been implemented in the currently enforced BE guideline, in that “one Subject with very low concentrations may be removed if the AUC for that period is less than 5% of the geometric mean AUC (calculated without the subject) for the product in question”. At the time of writing of this chapter, the ICH M13A guideline had not been yet adopted by Health Canada. However, its adoption is likely to result in two major changes for Immediate Release products. First, some of them will likely in the future necessitate both fed and fasted BE studies, and would be termed “high risk” products. Secondly, metabolites that are active and formed pre-systemically within the gut wall would need to be measured and presented with BE study results, in line with recommendations from the Office of Generic Drugs of the US FDA for almost 20 years.