Adoption of GL 28: Studies to Evaluate The Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing

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VICH Canada Coordinating Secretariat
Veterinary Drugs Directorate
Tower A, Ground Floor
14 - 11 Holland Avenue
Postal Locator 3000A
Ottawa, Ontario K1A 0K9

Re: Adoption of VICH GL 28: Studies to Evaluate The Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing

Dear Stakeholders:

I am pleased to inform you of the adoption of VICH GL 28, according to Step 7 of the VICH process. This guideline has been developed by the responsible VICH Expert Working Groups and has been subject to consultation. The VICH Steering Committee has endorsed this guideline and has recommended its adoption by the regulatory bodies of the European Union, Japan and the United States.

In adopting this VICH guideline, the Government of Canada endorses the principles and practices described therein. This document should be read in conjunction with the relevant sections of other applicable guidelines.

Guidelines are meant to provide assistance to industry and health care professionals on how to comply with Government of Canada's policies and governing statutes and regulations. They also serve to provide review and compliance guidance to Government of Canada staff, thereby ensuring that the policies and guidelines are implemented in a fair, consistent and effective manner.

Guidelines are administrative tools that do not have the force of law and, as such, some flexibility in approach is allowed. Alternative approaches to the principles and practices described in these documents may be acceptable provided they are supported by adequate scientific justification. Alternative approaches should be discussed in advance to avoid the possible determination through evaluations that applicable statutory or regulatory requirements have not been met.

It is important to note that Government of Canada reserves the right to request information or material, or define conditions not specifically described in this guidance, in order to allow the evaluators to adequately assess the safety, efficacy or quality of a veterinary drug. Government of Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This VICH Guideline is available on the Veterinary Drugs section of Health Canada's Web site at the following URL:

http://www.hc-sc.gc.ca/dhp-mps/legislation/vet/guide-ld/vich/index-eng.php

Should you have any questions regarding the content of the guidelines, please contact us at the following telephone number or e-mail address:

Telephone: (613) 954-5687
E-mail: vetdrugs-medsvet@hc-sc.gc.ca

Yours sincerely,

Kathy Dobbin
VICH Coordinator and Director of Strategic
Planning and Stakeholder Relations Division