Health Canada were seeking comments on possible changes to the Food and Drug Regulations relating to a proposed generic drug’s pharmaceutical equivalence to a Canadian reference product (CRP). They released a notice of intent which states that the proposal is intended “to address some concerns arising from the comparison of generic drug products to the CRP and create greater alignment and convergence with the practices of other major regulatory jurisdictions for pharmaceuticals”.
Key points include:
- providing definitions of a ‘medicinal ingredient’, ‘therapeutic moiety’ and ‘drug product’
- allowing abbreviated new drug submissions (ANDS) to be filed for ‘pharmaceutical alternatives’ and ‘pharmaceutical equivalents’
Health Canada required questions or comments on these changes to be provided before 27th October 2017.
In regard to the notice of intent, Health Canada also issued the Updated Notice: Interim Policy on Health Canada’s Interpretation of Medicinal Ingredient and Assessment of Identical Medicinal Ingredient. This is an updated version of Health Canada’s 2015 interim policy regarding the interpretation of a medicinal ingredient. The updated notice states that, if the medicinal ingredient is the same at the input stage and in the finished dosage form as the CRP then an ANDS is the appropriate route. It also clarifies other contributing factors as to how Heath Canada determines whether an ANDS is the appropriate route.
Additionally, the notice mentions that these matters will be explored further, at which point a guidance document will be issued.
It should be noted that if the generic drug submission makes a comparison or reference to a drug on the Patent Register, the Patented Medicines (Notice of Compliance) Regulations will continue to apply regardless of the determination of pharmaceutical equivalence.