Consultation on revised VICH guideline 36: Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological acceptable daily intake (ADI) (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 objectives of this guideline are to:

1. to outline the steps in determining the need for establishing a microbiological acceptable daily intake (ADI);
2. to recommend test systems and methods for determining no-observable adverse effect concentrations (NOAECs) and no-observable adverse effect levels (NOAELs) for the endpoints of health concern; and
3. to recommend a procedure to derive a microbiological ADI.

In comparison with the original VICH guideline 36, this revised guideline has included only one change, i.e., the addition of Appendix D aimed at providing additional guidance to determine the drug fraction of oral dose available to microorganisms.

How to Get Involved

This consultation is open for comment starting May 26 until July 11, 2011. 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 (DOC Version - 268 K)

Interested parties are encouraged to provide comments and suggestions by July 11, 2011.

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.