Health Canada last week released two draft guidances for public consultation as part of the agency’s effort to clarify the criteria for its abbreviated new drug submission (ANDS) pathway for generic drugs.
Specifically, the draft guidances detail how the agency intends to implement a recently proposed regulatory amendment aimed at boosting access to generic drugs and making labeling more consistent and transparent.
“The draft guidance documents have been released to support the proposed regulatory amendments which seek to clarify the eligibility criteria of the abbreviated new drug submission pathway used to approve certain generic drugs. The proposed regulations and guidance document are aimed at providing more clarity, consistency, transparency and predictability for manufacturers in filing drug submissions,” Health Canada writes.
Proposed Regulations & Guidance
Under the proposed regulations, Health Canada is looking to amend the definition of “pharmaceutical equivalent” to clarify whether a drug is eligible for the ANDS pathway and when a new drug submission (NDS) is required.
For pharmaceuticals, excluding radiopharmaceuticals, the definition of “pharmaceutical equivalent” will be updated to mean a drug that contains the same therapeutically active components in the same amounts and comparable dosage form as a Canadian reference product (CRP).
The definition is being changed to acknowledge that certain differences in the medicinal ingredient are allowable under the ANDS pathway, including drugs with active ingredients that are in a different hydrated or solvent form, different polymorphic form or different salt form.
“Due to pharmaceutical development strategies and manufacturing technologies, the medicinal ingredient in generic drug products sometimes differ from their CRP (e.g. a different salt, hydrate, or solvate of the medicinal ingredient), leading to difficulties in determining whether drugs are pharmaceutically equivalent such that they may be approved via the ANDS pathway,” Health Canada writes…