VICH guideline 52: Bioequivalence - Blood Level Bioequivalence Study (step 4) - 2014 Health Canada Consultation Notice

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, New Zealand and South Africa) 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 38 of the VICH guidelines for implementation in Canada.

This guideline is intended to harmonize the data requirements associated with in vivo blood level bioequivalence (BE) for veterinary pharmaceutical products.

How to Get Involved

This consultation is open for comment starting January 10, 2014 until February 25, 2014. 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 February 25, 2014.

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.