On October 5, 2017, Health Canada published an Updated Notice entitled, “Updated Notice: Interim Policy on Health Canada's Interpretation of Medicinal Ingredient and Assessment of Identical Medicinal Ingredient”. This notice updates the 2015 Interim Policy interpretation of “medicinal ingredient” in the Food and Drug Regulations. The Updated Notice may be of interest to generic pharmaceutical manufacturers who file an abbreviated new drug submissions (ANDS) to establish pharmaceutical equivalence with a Canadian Reference Product (CRP).
Canada interprets “medicinal ingredient” as the Active Pharmaceutical Ingredient (API) used as the raw material in the manufacturing of the finished dosage form (FDF). Health Canada evaluates pharmaceutical equivalence at the input stage. However, when deciding whether the two medicinal ingredients are “identical”, Health Canada also considers whether the manufacturing processes can lead to variations in the chemical form of the medicinal ingredients in the FDF. In the Updated Notice, Health Canada outlines the following scenarios when considering whether the two medicinal ingredients are “identical” for the purposes of evaluating an ANDS:
If the same medicinal ingredients at the input stage diverge into different physicochemical forms in the FDF (and the therapeutic moieties are the same), additional safety, effectiveness and quality data may be required.
If the medicinal ingredients are different physicochemical forms at the input stage and remain different physicochemical forms in the FDF (and the therapeutic moieties are the same), additional safety, effectiveness and quality data may be required.
If the medicinal ingredients are different physicochemical forms at the input stage but nonetheless converge into the same physicochemical form in the FDF, the medicinal ingredients will be considered “identical”, and additional safety, effectiveness and quality data will not be required.
The changes do not apply to biological or radiopharmaceutical products, or to medicinal ingredients which do not possess a unique chemical structure, such as polymers with varying molecular weights.
Health Canada is currently consulting on a Notice of Intent that proposes possible changes to the Food and Drug Regulations with respect to the establishment of pharmaceutical equivalence between a proposed generic drug product and the CRP. Health Canada’s proposal largely reflects its interim policy on interpretation of “medicinal ingredient”.
Summary By: Junyi Chen