This content is current only at the time of printing. This document was printed on 15 December 2018. A current copy is located at https://apvma.gov.au/node/897
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VICH (International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products) is a trilateral (European Union–Japan–United States) program that was established under the auspices of the World Organisation for Animal Health to harmonise technical requirements for veterinary product registration. Australia, Canada, New Zealand and South Africa have observer status on VICH.
The objectives of the VICH are:
- to establish and implement harmonised regulatory requirements for veterinary medicinal products in the VICH regions, which meet high quality, safety and efficacy standards and minimise the use of test animals and costs of product development
- to provide a basis for wider international harmonisation of registration requirements
- to monitor and maintain existing VICH guidelines, taking particular note of the International Conference on Harmonisation work program and, where necessary, update these VICH guidelines
- to ensure efficient processes for maintaining and monitoring the consistent interpretation of data requirements following the implementation of VICH guidelines
- by means of a constructive dialogue between regulatory authorities and industry, to provide technical guidance for responses to significant emerging global issues and science that affect regulatory requirements within VICH regions.
The APVMA supports the international harmonisation of requirements for data. The APVMA participates in the working process of the VICH Steering Committee, joins in Committee discussions and provides experts where appropriate to the VICH Expert Working Groups. However, Australia’s observer status does not confer voting rights in the VICH process.
To date, the APVMA has adopted VICH guidelines on data requirements for chemistry, human safety (toxicology), environmental safety, anthelmintics and good clinical practices.
Before adopting a VICH guideline, we ensure its suitability to Australian conditions. This practice reflects a principle in the APVMA Standard on Good Regulatory Science Practice—namely, that we will follow international, harmonised guidelines where it is possible or appropriate to do so.
When we adopt VICH guidelines that describe the global harmonisation of registration requirements, we minimise the use of test animals and the cost of product development, and increase the availability of veterinary medicinal products in Australia.