Multinational: Programs & Policies

MN: VICH

Last updated: December 7, 2007

The International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH) was established in 1996 with the goal of “harmonizing technical requirements for veterinary product registration” between the US, the EU, and Japan (VICH, 2005).

The objectives of the VICH are as follows:

  • Establish and monitor harmonized regulatory requirements for veterinary medicinal products in the VICH regions to 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
  • Monitor and maintain VICH guidelines, taking particular note of the ICH work program and, where necessary, update the guidelines
  • Ensure efficient processes for maintaining and monitoring consistent interpretation of data requirements following the implementation of VICH guidelines
  • 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

Members of the VICH include:

US:

  • Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM)
  • United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS)
  • Animal Health Institute (AHI)

EU:

  • European Commission (EC)
  • European Medicines Agency (EMEA)
  • International Federation for Animal Health Europe (IFAH-Europe)

Japan:

  • Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF)
  • Japanese Veterinary Products Association (JVPA)
  • Japanese Association of Veterinary Biologics (JAVB)

The VICH Steering Committee is the decision-making body of the VICH and is composed of four delegates from the three regions (two regulatory; two industry). The VICH Steering Committee selects topics for evaluation and assigns working groups to develop draft recommendations on each topic, and it also releases and adopts guidelines. There are 10 VICH Expert Working Groups (EWG): Quality, Safety, Ecotoxicity, Good Clinical Practice (GCP), Anthelmintics, Pharmacovigilance, Biologicals Quality Monitoring, Antimicrobial Resistance, Target Animal Safety, and Metabolism and Residue Kinetics. Specific topics addressed by each EWG are described on the VICH website.

Test Guidelines

The VICH and the FDA’s Center for Veterinary Medicine (CVM) provide a list of VICH guidance documents, which include guidance on stability, efficacy, ecotoxicity, and safety testing. VICH topics relevant to toxicity testing are covered primarily by the Safety and Ecotoxicity EWGs.

One of the safety topics addressed by the VICH is testing for the hazards associated with veterinary drug residues in food animals, which is assessed by the same laboratory animal toxicological tests as the ones used for human drugs and pesticides. The VICH Steering Committee has recommended a set of toxicological tests for this safety testing, which includes systemic toxicity (repeat-dose), reproduction toxicity, developmental toxicity, genotoxicity, carcinogenicity, and effects on the human intestinal flora (VICH Steering Committee, 2002). They selected toxicity tests that could determine a dose that will cause an adverse effect and a dose that will identify a no-observed adverse effect level (NOAEL). “A NOAEL is used to establish a human acceptable daily intake (ADI), which represents the amount of drug that can be safely consumed by a person on a daily basis for a lifetime” (VICH Steering Committee, 2002).

The VICH Ecotoxicity EWG is working on guidelines for assessing the environmental impact of veterinary medical products. The Phase I document does not address any toxicity testing requirement; the Phase II or Phase III guidelines are not yet available.

Alternatives Policies & Actions

A study of VICH documents illustrates the usefulness of the harmonization approach in eliminating duplication and/or repetition of safety testing within or between different countries and in reducing animal use for safety testing. For example, the VICH Steering Committee recommended a list of tests to be used to evaluate the safety of human foods containing residues of veterinary drugs (VICH Steering Committee, 2002). The objective for this guideline was to “provide an adequate amount of toxicological data to ensure human food safety, while reducing the number of animals used in testing and conserving resources. Whenever possible, flexibility, minimum number of animals, as well as alternative in vivo and in vitro tests have been recommended” (VICH Steering Committee, 2002).

The same VICH document states that their guidelines “do not preclude the possibility of alternative approaches that may offer an equivalent assurance of safety, including scientifically based reasons as to why such data may not need to be provided.” Therefore, a validated alternative method could be used to replace a VICH guideline for any of the required toxicological endpoints. However, VICH also notes that the testing approach outlined in its guideline is “subject to national standards,” which could be a roadblock to the use of an alternative method, depending on individual country/region policies.

References

International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Products (VICH). (2005). What is VICH? Available here.

VICH Steering Committee. (2002). Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to testing. VICH GL33 (SAFETY: GENERAL APPROACH) October 2002 For implementation at Step 7 – Final. Available here.