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VICH

The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products

The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) is a trilateral program that brings together regulatory authorities and experts from the animal health industry in three regions (European Union, Japan and the United States). Regulatory authorities and industry experts from Australia, New Zealand and Canada participate in an observer capacity. VICH was officially launched in April 1996 and is conducted under the auspices of the Office International des Epizooties (OIE), World Organisation for Animal Health. Its primary objective is aimed at harmonizing technical requirements for registration of new veterinary medicinal products.

Canadian government representatives at VICH are from the Veterinary Drugs Directorate (VDD) of Health Canada (HC) and the Veterinary Biologics Section (VBS) of the Canadian Food Inspection Agency (CFIA). The VDD provides expertise regarding veterinary drugs while the VBS fulfills a similar role for veterinary biologicals. The VDD also serves as the Canadian Secretariat. More comprehensive information on Canada’s participation in VICH , stakeholder consultation process and publication of guidelines can be found at the VDD website at http://www.hc-sc.gc.ca/vetdrugs-medsvet/vich_e.html.

The primary outputs of the VICH process are the development of harmonized guidelines which result from scientific consensus of the requirements of the participating regions. Specific guidelines pertinent to the regulation of veterinary biological products can be viewed at the VBS website at http://www.inspection.gc.ca/english/anima/vetbio/fore.shtml or at the Center for Veterinary Biologics, United States Department of Agriculture website at http://www.aphis.usda.gov/vs/cvb/.

For more information on the history, structure, activities and guidelines of the VICH, please visit their website at http://vich.eudra.org/.

Guidelines

Although the Veterinary Biologics Section (VBS) intends to adopt VICH guidelines as primary guidance documents, they are to be viewed as administrative instruments and not specified requirements of the Health of Animals Act and Regulations and therefore allow for flexibility of approach. Alternate approaches to the principles and practices described in the guidelines may be acceptable, provided they are supported by adequate scientific justification. Alternate approaches should be discussed in advance with the VBS to help ensure that regulatory requirements can be met.

• VICH Guidelines Adopted by Canada
  • VICH GL 25 - Testing of Residual Formaldehyde
  • VICH GL 26 - Testing of Residual Moisture

• Summary Table of VICH Guidelines
• Official Texts of Final Guidelines
• Official Texts of Draft Guidelines