On March 30, 2019, the new proposed Regulations Amending the Food and Drug Regulations (Improving Access to Generics) (the "Regulations") were published in Canada Gazette, Part I. The proposed Regulations seek to improve access to generic medicines in Canada by clarifying the eligibility criteria of the Abbreviated New Drug Submission (“ANDS”) pathway for approving certain generic drugs.

The Food and Drug Regulations (“FDR”) allow a manufacturer to file an ANDS where the new drug is the pharmaceutical equivalent of drug previously approved by the Minister of Health (i.e. the Canadian reference product, “CRP”). Under the current FDR, a generic drug product is considered to be the pharmaceutical equivalent of a CRP if it contains “identical medicinal ingredients.” Under the proposed Regulations, ANDS eligibility of generic drug products, excluding biologics and radiopharmaceuticals, would be determined instead by assessing whether the new drug has identical amounts of “identical therapeutically active component” as the CPR.

Generic drug products with the following differences in the medicinal ingredient in comparison to the CRP, with the identical therapeutically active component, would be eligible to file via the ANDS pathway:

  • different hydrated or solvated forms;
  • different polymorphic forms; and
  • different salt forms.

However, these differences would not be eligible, and must be filed via the New Drug Submission pathway:

  • different complexes;
  • different clathrates;
  • different esters; and
  • different isomers or mixtures with different proportions of isomers.

These amendments codify Health Canada’s 2017 interim policy relating to the interpretation of medicinal ingredient. The proposed Regulations will only apply to generic drug product submissions with a filing date after the coming into force date.

Health Canada is holding a consultation until June 17, 2019 on related two draft guidance documents that outline the implementation of the proposed Regulations.

Summary By: Anna Troshchynsky


19 06 12

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