Health Canada is seeking input on potential changes to the Food and Drug Regulations affecting which drug products would be approvable by way of an abbreviated new drug submission (ANDS) and thus be designated therapeutically equivalent. Comments can be provided until October 13, 2017. This is the first in a series of consultations on the topic.

The proposed changes

Generic drug products can be approved via the ANDS pathway by making reference to a Canadian reference product (CRP), provided the manufacturer can demonstrate that its product is pharmaceutically equivalent and bioequivalent to the CRP, it has the same route of administration, and the conditions of use fall within those of the CRP. Approval through the ANDS pathway constitutes a declaration of “therapeutic equivalence.”

Products with the same medicinal ingredient in the same dosage form are currently considered “pharmaceutical equivalents.”  The proposed changes would allow drug products with different salts, esters, or complexes of the medicinal ingredient, and/or generic drug products with different but comparable dosage forms to the CRP to be considered “pharmaceutical alternatives.” Both pharmaceutical equivalents and pharmaceutical alternatives would be viewed as therapeutically equivalent, provided bioequivalence with the CRP has been demonstrated and the product has the same route of administration and the same safety and effectiveness.

Further, Health Canada is proposing a new definition for “medicinal ingredient” that would change when “sameness” between the generic product and its CRP is determined. Currently, the input material (i.e., the active pharmaceutical ingredient that goes into the manufacture of the drug product) is considered the medicinal ingredient. Health Canada is proposing to “add a definition of medicinal ingredient as the active substance that contains the therapeutic moiety in the drug product that is administered to or consumed by Canadians.”


Possible Changes to the Food and Drug Regulations: Generic Drug Equivalence and Related Terminology