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

Retrieved from: https://www.canada.ca/en/health-canada/services/drugs-health-products/public-involvement-consultations/drug-products/generic-drug-equivalence-notice.html


This Notice of Intent serves to solicit comments on possible changes to the Food and Drug Regulations around establishing pharmaceutical equivalence between a proposed generic drug product and the Canadian Reference Product (CRP). Health Canada also proposes to define the meaning of “medicinal ingredient” and other key terms (e.g., therapeutic moiety and drug product). In doing so, Health Canada aims to create greater alignment and convergence with the practices of other major regulatory jurisdictions and to standardize their use with those applied internationally.

Further, Health Canada is proposing to introduce language in the Food and Drug Regulations that would recognize generic drug products which contain the same therapeutic moiety in the medicinal ingredient as the CRP, but for which the medicinal ingredient is in a different physicochemical form (e.g., salt form), as approvable under an Abbreviated New Drug Submission (ANDS). If the therapeutic moieties are the same, and the differences in the physicochemical form of the medicinal ingredient do not result in a difference in safety or effectiveness, then these generic drug products would be considered “pharmaceutical alternatives” to the CRP and approvable as ANDSs, such that the resulting Notice of Compliance (NOC) would constitute a declaration of “therapeutic equivalence” to the CRP. It is not expected that this aspect of the proposal, which is specific to ANDSs, would apply to biological or radiopharmaceutical products, or to medicinal ingredients which do not possess a unique chemical structure (e.g., polymers with varying molecular weights).

Providing Your Input

Questions or comments related to the consultation, including cost and savings considerations, should be directed before October 13, 2017 to:

Health Canada
Health Products and Food Branch, Therapeutic Products Directorate
Bureau of Policy, Science and International Programs
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott St.
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Fax number: 613-941-1812
Email: policy_bureau_enquiries@hc-sc.gc.ca

Input received by October 13, 2017 will be considered as part of future regulatory development. Please be aware that this is the first in a series of consultations on the topic.