Guidance for industry: Preparation of veterinary abbreviated new drug submissions (generic drugs) - Clinical and human safety requirements: Regulatory requirements

Part 3: Regulatory requirements

3.1 Canadian reference product

Note that this guidance document includes Canadian Reference Product (CRP) and Foreign-sourced Reference Product (FRP) terminology in specific instances, and uses "reference product" in situations that can apply to both.

To file an ANDS, a sponsor's generic new drug product must meet several regulatory requirements in comparison to a CRP. A CRP is defined under section C.08.001.1 of the FDR. As defined in paragraph (a) of the CRP definition, the CRP is the Canadian innovator product, which has received a notice of compliance (NOC), and which is marketed in Canada by the innovator of the drug. Such a CRP will have a drug identification number (DIN) and Canadian labelling.

If the innovator product is no longer marketed in Canada, another reference product that is acceptable to the Minister may be used pursuant to paragraph (b) of the CRP definition under C.08.001.1 of the FDR. The next approved product (or first generic approved based on the innovator) marketed in Canada could be used as a reference product, if otherwise acceptable to the Minister. It is recommended that sponsors interested in using a reference product other than the first approved drug (innovator product) contact the Veterinary Drugs Directorate (VDD) to confirm its appropriateness as an alternate reference product: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca

3.2 Foreign-sourced reference product

Pursuant to paragraph (c) of the CRP definition under section C.08.001.1 of the FDR, a drug can be a CRP if it is acceptable to the Minister and can be used for the purpose of demonstrating bioequivalence on the basis of pharmaceutical and, where applicable, bioavailability characteristics, to the CRP. An ANDS may seek to use a FRP as its CRP pursuant to paragraph (c) of the CRP definition. If bioequivalence studies or in vitro studies were performed using an FRP, the ANDS sponsor must demonstrate bioequivalence of the FRP to the CRP (e.g. the drug that would otherwise have been identified as the CRP in accordance with paragraph C.08.001.1(a)).

For details on the criteria required to demonstrate equivalency (i.e. bridging) of the FRP with the CRP (such as with bioavailability, pharmacodynamic, clinical studies or a combination thereof), refer to the following guidance document:

Use of foreign-sourced reference product as a Canadian reference product

It is recommended that sponsors contact VDD before filing an ANDS to confirm the acceptability of using an FRP: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca

3.3 Eligibility for an ANDS

According to subsection C.08.002.1(1) of the FDR, an ANDS product must:

be pharmaceutically equivalent to the CRP;
be bioequivalent to the CRP;
have the same route of administration as that of the CRP; and
have conditions of use that fall within the conditions of use for the CRP.

Pharmaceutical equivalence is defined in section C.08.001.1 of the FDR. While identical amounts of the identical medicinal ingredient(s) are required, in comparable dosage forms, an ANDS drug does not necessarily need to contain the same non-medicinal ingredients (excipients) as those in the CRP. Refer to the Guidance for Industry: Preparation of Veterinary New Drug Submissions and Abbreviated New Drug Submissions (New and Generic Drugs) - Quality Requirements for additional information on pharmaceutical equivalence.

Generic drugs meeting all of the following criteria would be eligible for an ANDS:

an acceptable reference product is available;
an identical medicinal ingredient to the CRP;
an identical amount of the medicinal ingredient in the CRP;
a comparable dosage form to the CRP (see the section on Differences in dosage forms for more information);
the same route of administration to the CRP; and
conditions of use within those of the CRP (for example, used in the same species, with the same indications and the same dosage and administration as the reference product)

Differences in dosage forms

The dosage form of a proposed ANDS product must be comparable to the dosage form of the CRP. There are some dosage forms that are not considered comparable and would not be eligible for the ANDS pathway. Examples include:

Solid oral formulations (such as tablets) and liquid oral formulations (such as solutions)
Liquid oral formulations (such as solutions) and semi-solid oral dosage forms (such as pastes)
Parenteral aqueous solutions and parenteral non-aqueous solutions
Examples of dosage forms that may require further discussion with VDD could include:
Tablets and capsules
Scored tablets and non-scored tablets (key consideration is dosing and accuracy)
Powdered and granulated medicated premixes

For any questions or uncertainties about whether the generic product has a comparable dosage form to the CRP, it is recommended that sponsors contact VDD before filing a submission: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca

Delivery and/or dosing device

If the CRP was approved with a delivery and/or dosing device, the generic drug product must also have such a device. To be acceptable, the generic's device must have identical critical characteristics (such as amount and rate of drug delivered) to those of the CRP's device. For any questions or uncertainties in this area, it is recommended that sponsors contact VDD before filing a submission: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca

Non-eligibility for an ANDS

It is possible that a drug product that is pharmaceutically equivalent and bioequivalent to the CRP, with the same route of administration as the CRP, may not be considered eligible as an ANDS drug due to a difference in its conditions of use, specifically that its conditions of use do not fall within those of the CRP (such as new species or new indication). If the proposed generic product does not meet the eligibility criteria listed above, approval through the NDS pathway may be possible.

Page details

Date modified:: 2025-03-14

Language selection

Search