Veterinary drugs - Management of regulatory submissions guidance: Overview

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• Introduction
• An overview of regulatory submission types for veterinary drugs

Introduction

This guidance will inform sponsors about the process the Veterinary Drugs Directorate (VDD) of Health Canada follows for managing regulatory submissions and related information filed by submission applicants (referred to as sponsors hereafter). This process aligns with the Food and Drugs Act and the Food and Drug Regulations where all drugs, unless specifically exempted, must be authorized before being sold or imported for sale in Canada. The VDD is the regulatory authority for the administration of the Food and Drugs Act and regulations for the sale of drugs intended for use in animals.

This document also provides guidance to sponsors on how to comply with the Food and Drugs Act and regulations and VDD's policies.

Scope and application

This guidance applies to veterinary submission types including:

• new drug submission (NDS)
• supplemental new drug submission (SNDS)
• abbreviated new drug submission (ANDS)
• supplemental abbreviated new drug submission (SANDS)
• notifiable change (NC)
• drug identification number (DIN) application and change to DIN
• administrative NDS/ANDS or DIN submission filed in support of manufacturer name change, change in product ownership, merger/buyout, additional product name and licensing agreements
• administrative SNDS/SANDS or DIN submission filed in support of a product name change
• experimental studies certificate (ESC) application and ESC amendments
• protocol reviews
• investigational new drug submissions (INDs) and IND amendments

Please contact the Submission and Knowledge Management Division (SKMD) at vdd.skmd.so-dgps.dmv.cp@hc-sc.gc.ca for further guidance on protocol reviews.

Processes to notify a veterinary health product (VHP) or to seek access to a veterinary drug through the Emergency Drug Release (EDR) program are not within the scope of this document. For information about our VHP Notification program, please contact vhp-psa@hc-sc.gc.ca. For information about the EDR program, please contact edr-dmu@hc-sc.gc.ca.

Submissions filed under joint review or simultaneous review initiatives with other regulatory jurisdictions (for example, Regulatory Cooperation Council [RCC] initiative with the U.S. Food and Drug Administration's Center for Veterinary Medicine) may be subject to provisions outside of this guidance document. Contact the VDD for submissions filed under joint or simultaneous reviews at vdd.vetdrugs-medsvet.dmv@hc-sc.gc.ca.

For each of the applicable submission types, this guidance outlines the process for each stage of the submission review and approval process, including the:

• pre-submission phase
• initial processing of submission
• screening of submission
• review of submission
• final review decision

The VDD will apply the same submission management principles during each stage of the submission review and approval process. The VDD will make related decisions within its performance targets (see Appendix A).

Information regarding the following regulatory activities is included:

• administrative amendments to submissions under review
• unsolicited amendments to submissions under review
• withdrawal of submissions under review
• refiled submissions
• post-approval obligations
• access to submission-related information

In summary, this is an administrative procedural document. Sponsors should consult the Food and Drugs Act and regulations as well as applicable Health Canada policies and scientific guidance documents to ensure that all required data components are included at the time of filing.

An overview of regulatory submission types for veterinary drugs

Request for authorization to sell a drug that does not have a DIN

A researcher may seek authorization to permit the sale of a drug without a DIN:

• as part of a veterinary drug study, such as preliminary research
• to generate data to support a veterinary drug regulatory submission in Canada

A drug without a DIN may be sold when 1 of the following submissions are filed and a written authorization is obtained from the VDD:

• an experimental studies certificate (ESC)
• a pre-clinical submission (referred to as an investigational new drug (IND) submission)

Request for marketing authorization

A drug must have a valid DIN to be sold or imported for sale (referred to as sold hereafter) in Canada. The sponsor can, depending on the drug in question, submit 1 of the listed regulatory submissions to the VDD for their request to obtain a DIN for selling a veterinary drug in Canada:

• a drug identification number (DIN) submission
• a new drug submission (NDS)
• an abbreviated NDS (ANDS)

Post-approval authorizations: Scientific amendments to initial marketing authorization

Filing updated information

After a sponsor has received a marketing authorization for a new drug, the sponsor needs to file certain updated information or changes to the new drug prior to implementation. Depending on the nature of the changes made, the sponsor needs to file 1 of the submission types:

• supplement to a new drug submission (SNDS) or supplement to an abbreviated new drug submission (SANDS)
• notifiable change (NC) submission
• level III notification (not subject to review and approval)

If a sponsor is seeking to make a change to the marketing authorization for a drug that is not a "new drug," the sponsor needs to file a:

• change to DIN application

Reactivation of a cancelled DIN by Health Canada

Either Health Canada or the DIN holder can cancel the DIN for a drug in accordance with Section C.01.014.6 of the Food and Drug Regulations.

Once a DIN has been cancelled, the sponsor needs to submit a new submission to re-gain marketing approval for a product. The VDD may permit cross references to previously filed information. However, the VDD may also require additional information to ensure that the submission complies with the current regulations and guidelines.