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

Introduction

This document provides drug manufacturers (referred to as sponsors hereafter) with guidance on the clinical and human safety requirements for preparing the following submission types for regulatory approval of a veterinary generic drug in Canada:

Abbreviated New Drug Submission (ANDS)
Supplement to an ANDS (SANDS)

Note that the quality requirements for the preparation of a veterinary new drug submission (NDS) and ANDS, are available in a separate document: Guidance for Industry: Preparation of Veterinary New Drug Submissions and Abbreviated New Drug Submissions (New and Generic Drugs) - Quality Requirements.

This guidance document:

Provides clarity and consistency in the interpretation of and guidance on the regulatory requirements of the Food and Drug Regulations (FDR)
Reflects feedback received from stakeholders during consultation
Provides guidance to Health Canada staff, so that the rules are followed in a fair, consistent and effective way
Outlines many scenarios and examples, yet it is not intended to cover every possible case (for example, as new technologies and approaches emerge, different considerations may be called for)
Has been written with a view to harmonize with international approaches, such as the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) and other regulatory agencies in other countries
Replaces the previous Guidance for Industry - Preparation of Veterinary Abbreviated New Drug Submissions - Generic Drugs
According to subsection C.08.002.1(1) of the FDR, a generic drug can be approved by way of an Abbreviated New Drug Submission (ANDS) if:
It is pharmaceutically equivalent to the Canadian Reference Product (CRP);
It is bioequivalent to the CRP;
It has the same route of administration as that of the CRP; and
Its conditions of use fall within the conditions of use for the CRP.
Notes:
- Pharmaceutical equivalent is defined in section C.08.001.1 of the FDR: means a new drug that, in comparison with another drug, contains identical amounts of the identical medicinal ingredients, in comparable dosage forms, but that does not necessarily contain the same non-medicinal ingredients.
- The requirement that the conditions of use of the ANDS product fall 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) means that the conditions of use for the ANDS product can be no broader than those approved for the CRP.

Drug submissions are required to contain sufficient information and material to enable the Minister to assess a product's safety and effectiveness. The ANDS pathway permits Health Canada to review and approve generic drugs based on an abbreviated submission if certain eligibility requirements are met. The purpose of demonstrating pharmaceutical equivalence and bioequivalence against a reference product is to provide evidence that the safety and efficacy profiles of the subsequent-entry (generic) product will be equivalent to that of the reference product for which safety and efficacy has been demonstrated. We may request additional information or clarification to help adequately assess the ANDS.

The filing and approval of an ANDS may be subject to requirements under the Patented Medicines (Notice of Compliance) Regulations and the data protection provisions under section C.08.004.1 of the FDR. For more information about patents, certificates of supplementary protection, the patent register, and data protection, contact Health Canada's Office of Patented Medicines and Liaison at: opml-bmbl@hc-sc.gc.ca

If you have questions about this guidance document or a particular scenario that may not be covered, contact us: vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca

Scope and application

Within the context of the Food and Drug Regulations, this guidance document applies to veterinary generic drugs (not innovator products).

It does not apply to biological veterinary drugs (such as stem cell and monoclonal antibody products) or veterinary health products (VHPs).

Structure and content

This guidance contains 4 main sections that describe the requirements that an ANDS must meet, supported by examples, points of clarification as well as appendices.

Part 3: Regulatory requirements

This section outlines relevant provisions in the FDR with respect to generic drugs. It includes information on reference products, and ANDS eligibility criteria. Specific provisions in the FDR have been included for reference.

Part 4: Clinical requirements

This section outlines technical clinical requirements for an ANDS and supporting information on bioequivalence (including eligibility and requirements for biowaivers and bioequivalence studies), physicochemical properties, and situations where additional data may be required.

Note that the Comprehensive Summary - Bioequivalence (CS-BE) template is a tool (optional) intended to support sponsors by providing a standardized approach to filing study results for Health Canada review as part of an ANDS (folder 1.11.4).

Part 5: Human safety requirements

This section contains the human safety data requirements for ANDS products. It includes details on toxicological and microbiological safety, residue depletion studies, and conditions under which a waiver of residue depletion studies may be granted. This section also clarifies that the regulatory requirement for generic drugs intended for administration to food-producing animals is to have an identical withdrawal period/milk withholding time to that of the CRP.

Labelling requirements

This section provides specific labelling requirements for an ANDS and is supplementary to the broader Guidance on veterinary drug labelling, which provides sponsors with guidance on how to meet the requirements of the Food and Drugs Act and Food and Drug Regulations for veterinary drug labelling and packaging in Canada.

Appendices

Appendix 1 provides more technical information with regard to biowaiver eligibility for additional strengths of solid oral immediate release dosage forms that have demonstrated bioequivalence with the highest strength of the CRP.

Appendix 2 includes key definitions used throughout the guidance for reference and additional context.

Appendix 3 outlines the Master Index for an Abbreviated New Drug Submission (ANDS) that aligns with this guidance document, as well as the electronic zip folder structure for filing submissions.

Note about guidances in general

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also help to support the implementation of Health Canada mandates and objectives in a manner that is fair, consistent, and effective.

Guidance documents are administrative instruments not having the force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate justification. Alternate approaches should be discussed in advance to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, in order to allow the Department to adequately assess the safety, efficacy, or quality of a drug product.

This guidance document should be read in conjunction with the relevant sections of other applicable guidance documents, in addition to relevant statutes and regulations where applicable.

Page details

Date modified:: 2025-03-14

Language selection

Search