CVM's Participation in the International Cooperation of Harmonization of Technical Requirements for Registration of Veterinary Products
VICH is an international industry/government effort that was initiated in April 1996 by the World Organization for Animal Health (OIE), International Federation of Animal Health (IFAH), Japan, the United States, and the EU to develop consensus guidelines that describe the study protocols and designs for the testing required to demonstrate product safety, quality, and efficacy for the purpose of licensing or registering veterinary medicines in VICH participating countries. In addition to preapproval study requirements, VICH has also developed guidance for post-marketing monitoring and reporting of Adverse Drug Events. Since 1996, CVM has served on the VICH Steering Committee and on all of the Expert Working Groups covering all VICH subjects related to veterinary drugs. APHIS’ Center for Veterinary Biologics co-represents the United States in VICH and covers veterinary biologics subject matter. Canada, New Zealand, and Australia also participate in VICH as observing countries. Since 1996 VICH has also held four public meetings.
The primary objectives of VICH are to:
- Establish and implement harmonized regulatory requirements for veterinary medicinal products in the VICH regions, which meet high quality, safety and efficacy standards and minimize the use of test animals and costs of product development.
- Provide a basis for wider international harmonization of registration requirements.
- By means of a constructive dialogue between regulatory authorities and industry provide technical guidance enabling response to significant emerging global issues and science that impact on regulatory requirements within the VICH regions.
The following parties participate in VICH:
European Commission, European Medicines Agency (EMA), IFAH Europe, the CVM, the CVB, Animal Health Institute, Japanese Ministry of Agriculture, Forestry, and Fisheries, Japanese Veterinary Pharmaceutical Association, Japanese Animal Veterinary Biologics, Australian Pesticide and Veterinary Medicines Authority, the New Zealand Food Safety Authority, the Australian Animal Health Alliance, the Agricultural Chemicals & Animal Remedies Manufacturers' Association of New Zealand, Health Canada’s Veterinary Drugs Directorate (VDD), the Canadian Food Inspection Agency, the Canadian Animal Health Institute, OIE, and IFAH.
In 2011 VICH implemented its Global Outreach Initiative to share with countries that have not been participating in VICH information about VICH procedures and accomplishments. The general goal of the VICH Global Outreach Initiative is to raise the level of understanding and acceptance of VICH guidelines in many of the countries that have not heretofore participated in VICH. VICH is working closely with OIE and its worldwide network of countries and offices to implement the VICH Global Outreach Initiative.