Consultation on revised VICH guideline 23: Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity testing (step 4)

VICH (International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products) is a trilateral (EU-Japan-USA) program aimed at harmonizing technical requirements for veterinary product registration. Canada (along with Australia and New Zealand) is an observer country at VICH, and the Veterinary Drugs Directorate (VDD) is the VICH Coordinating Secretariat for Canada. The VICH Guidelines provide assistance to industry and healthcare professionals on how to comply with the Government of Canada's policies and governing statutes and regulations. They also serve to provide review and compliance guidance internally, thereby ensuring that the policies and guidelines are implemented in a fair, consistent and effective manner. Before VICH guidelines are adopted or moved to the next step in the adoption process, they are usually submitted to each participating country's industry for consultation and comments on the draft guideline. The VDD has adopted 37 of the VICH guidelines for implementation in Canada.

The objective of this guideline is to ensure international harmonisation of genotoxicity testing.

In comparison with the original VICH guideline 23, which was adopted for implementation in Canada in October 2004, the revised document provides further clarification and specificity regarding the types of genotoxicity studies required. It also removes regional-specific test preferences in an effort to further harmonize genotoxicity requirements.

How to Get Involved

This consultation is open for comment starting January 21 until March 1, 2013. Please select and read through the link below titled "Letter to Stakeholders". Once read please submit your comments via email or by mail to:

consultationVDD-DMV@hc-sc.gc.ca

International Liaison Officer
Veterinary Drugs Directorate
Health Products and Food Branch
Ground Floor, Suite 14 - Holland Cross Complex
11 Holland Avenue
Ottawa, Ontario K1A 0K9
Postal Locator 3000A

Letter to Stakeholders

 Draft VICH Guidance

Interested parties are encouraged to provide comments and suggestions by March 1, 2013.

Reporting to Canadians

Health Canada will make the results of this consultation available on this Web site.

If you have any questions, contact us at: consultationVDD-DMV@hc-sc.gc.ca.