Health Canada Opens Generic Drug Guidances for Consultation

Regulatory NewsRegulatory News | 16 April 2019 |  By 

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“The draft guidance documents have been released to support the proposed regulatory amendments which seek to clarify the eligibility criteria of the abbreviated new drug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.
According to Health Canada, the amendment would bring the agency’s approach to generic drugs more in line with the approaches used by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). While FDA has a separate type of application, known as a 505(b)(2) new drug application (NDA) that accommodates for changes in dosage form, strength and other changes from a reference product, EMA uses the same pathway for all generic drugs.
For radiopharmaceuticals, Health Canada specifies that the drug must contain “identical amounts of the identical medicinal ingredients.” The proposal also does not apply to biosimilars, which must be submitted under the NDS pathway.
The proposed regulations also include provisions to require labeling to include the “name of the form of the medicinal ingredient in the dosage form, and not the input ingredient” and to streamline how pharmaceutical strength is expressed to reduce the chance of inaccurate dosing.
In the draft guidance Generic Drug Equivalence: Medicinal Ingredients, Health Canada explains how sponsors can demonstrate that their drug is therapeutically equivalent to its reference product when there are differences in the medicinal ingredient.
In the second draft guidance, Identifying and Labelling Medicinal Ingredients in New Drug Products, Health Canada explains how medicinal ingredients for new and generic drugs should be labeled. “The labelling should reflect the therapeutically active component and medicinal ingredient most likely present in the dosage form (if different from the therapeutically active component),” Health Canada writes.
Health Canada is asking for interested parties to submit comments on the two draft guidances by 17 June.
Consultation, Proposed Regulation, Generic Drug Equivalence: Medicinal Ingredients, Identifying and Labelling Medicinal Ingredients in New Drug Products


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