Possible changes to Food and Drug Regulations
Consultation on proposals for prescription drug transparency

Possible changes to Food and Drug Regulations

Generic drug equivalence and related terminology
Health Canada recently issued a notice of intent soliciting 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). The notice of intent 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 concepts outlined in the notice of intent include:

  • providing definitions of a 'medicinal ingredient', 'therapeutic moiety' and 'drug product', such that a medicinal ingredient will be defined as the active substance that contains the therapeutic moiety in the drug product that is administered to or consumed by Canadians; and
  • allowing abbreviated new drug submissions (ANDS) to be filed for:
    • 'pharmaceutical alternatives' (ie, generic drugs with different salts, esters or complexes of the medicinal ingredient and generic drug products with different but comparable dosage forms as the CRP) when bioequivalence has been demonstrated and the generic drug is as safe and effective as the CRP; and:
    • the 'pharmaceutical equivalents' allowed at present (ie, generic drugs with identical medicinal ingredients in comparable dosage forms as the CRP).

On issuance, a notice of compliance would constitute a declaration of therapeutic equivalence in both of the above instances.

Health Canada required questions or comments to be provided to it before October 27 2017.

Interpretation of a medicinal ingredient
In regard to the above notice of intent, Health Canada issued the Updated Notice: Interim Policy on Health Canada's Interpretation of Medicinal Ingredient and Assessment of Identical Medicinal Ingredient. This updated Health Canada's 2015 interim policy regarding the interpretation of a medicinal ingredient.(1) According to the updated notice, if the medicinal ingredient is the same at the input stage and in the finished dosage form as the CRP, an ANDS is the appropriate route. The updated notice clarifies that Health Canada also considers the following scenarios in determining whether an ANDS may be the appropriate route:

  • An ANDS may be appropriate, although additional safety, effectiveness and quality data may be required, if:
    • the input medicinal ingredients are the same, but diverge to different physicochemical forms in the finished dosage form; or
    • the input medicinal ingredients are different physicochemical forms and remain different in the finished dosage form.
  • An ANDS may be appropriate without additional safety, effectiveness and quality data if the input medicinal ingredients are different physicochemical forms, but converge to the same physicochemical form in the finished dosage form.

The updated notice also states that this issue will be further developed with the larger policy framework that includes the above potential amendments to the Food and Drug Regulations, at which point a guidance document will be issued.

The Patented Medicines (Notice of Compliance) Regulations will continue to apply if the generic drug submission makes a comparison or reference to a drug on the Patent Register, regardless of the determination of pharmaceutical equivalence.

Consultation on proposals for prescription drug transparency

Health Canada solicited online comments regarding proposed pre-market transparency initiatives for human prescription drugs (pharmaceuticals and biologics) up until October 28 2017. Feedback could be submitted only through the consultation document, which contained additional information on:

  • publishing a summary explaining Health Canada's decision on certain prescription generic drug submissions;
  • publishing a list of prescription generic drug submissions sent to Health Canada for review;
  • expanding the scope of the existing regulatory decision summary initiative to include more drug submissions; and
  • adding company (sponsor) names and the submission 'class' to entries on the Submissions Under Review List.

For further information on this topic please contact Urszula Wojtyra or Andrew Mandlsohn at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email ([email protected] or [email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.


(1) Further information is available here.