Veterinary Drugs Directorate Draft Guidance - Priority Review Of Veterinary Drug Submissions


Introduction: Commensurate with its mandate, the Veterinary Drugs Directorate (VDD) recognizes that there may be a need on a case-by-case and exceptional basis to give priority review to a drug submission for health and safety reasons.

Purpose: To provide guidance and elaborate the procedure for the priority review of veterinary drug submissions.

Scope: This document establishes the requirements and provides guidance to sponsors in the preparation and submission, based on a standardized application procedure and eligibility criteria, of a Priority Review of a New Drug Submission or a Supplemental New Drug Submission, as described below. Priority review of a submission would not be based on economic considerations nor would the guidance and procedures apply to any other veterinary drug submission type.

Note: Priority review would apply to the specific drug and to the specific indication or indications for which priority review status is being requested and for no others.

Eligibility Criteria: A Request for Priority Review Must Meet Criteria 1 or 2.

The application must be for either:

(1) The treatment of a serious, life-threatening or severe debilitating disease or condition in animals and for which there is evidence that the drug provides:

Effective treatment, and/or prevention, of a disease or condition for which no veterinary drug is presently approved for sale and marketed in Canada;

An increase in efficacy and/or decrease in risk, such that the overall benefit/risk profile is improved over existing therapies and preventatives, available in Canada.

(2) The treatment of a disease in animals which would result in a gain to public health and for which there is evidence that the drug provides:

Effective treatment, and/or prevention, of a disease or condition for which no veterinary drug is presently approved for sale and marketed in Canada.;

An increase in efficacy and/or decrease in risk, such that the overall benefit/risk profile is improved over existing therapies and preventatives, available in Canada.

Procedures:

Sponsor:

Note: Sponsors are encouraged to make a brief presentation to the Directorate prior to submitting a request for Priority Review status.

The sponsor must present a written request for Priority Review of a submission to the Director General, Veterinary Drugs Directorate.

(A) Information concerning the request should be provided under the following (20 pages or less):

1 - Identification of the product (trade name, common name, etc).

2 - Rationale for the request: As per the Eligibility Criteria (page 1)

3 - Clinical Evidence: A synopsis of the clinical evidence establishing that the product provides effective treatment and/or prevention, of a disease or condition for which no veterinary drug is presently approved for sale and marketed in Canada.

4 - A brief description of the disease or condition and the role of the product.

5 - Risk Analysis: A summary of the risk-analysis for the product and/or the improvements it represents over existing products (if applicable).

(B) The full submission must accompany the request.

(C) If the request is not accepted the sponsor should indicate his preference as to the disposition of the submission as indicated below.

Note: Priority review submissions are subject to the normal method of processing of submissions in VDD.

Veterinary Drugs Directorate:

The request will be reviewed for consideration and decision. The Directorate will notify the sponsor of the decision made within 45 calendar days of receipt of the original request. The screening of the submission will be done concurrently with the request for priority.

If the request is not accepted, the submission would then at the choice of the sponsor either:

  1. enter the review queue for screening and review as a non-priority submission; or
  2. be returned to the sponsor.

If the submission is found to be unacceptable after screening then the sponsor must reapply for Priority Review consideration.

A request for Priority Review may be rejected for the following reasons (including but not limited to):

  • failure to provide the required information listed above (see Procedures- Sponsor).
  • failure to demonstrate that the product satisfies the eligibility criteria outlined above.
  • submission after screening found to be unacceptable for review.

Initiation Of Review: Applications granted Priority Review status will be the next file in the priority queue to be initiated for review in all divisions.

Maintenance of Priority Review Status:

Once a priority review status is granted, this status will apply to the entire review process for that product, including application for the DIN number and issuance of the Notice Of Compliance.

It is expected that sponsors of Priority Review requests market the product in a timely fashion (normally within 60 days).

Appeal:

If the sponsor wishes to appeal the decision, a written letter of intent to appeal should be sent to the Director General, Veterinary Drugs Directorate within 30 calendar days of the date of the letter outlining the Directorate's decision.

Priority Review Requests Should Be Sent To The Following Address:

Veterinary Drugs Directorate
Submission & Knowledge Management Division
Health Products and Food Branch
Holland Cross Complex
Ground Floor, Suite 14
11 Holland Avenue
AL 3000A
Ottawa, Ontario K1A 0K9

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