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AgVetLink: Number 62, June 2007

VICH: Keeping Australia and New Zealand up with the rest of the world

What is VICH?

VICH is the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). It is an organisation that brings together the regulatory authorities and representatives from the veterinary medicinal products industry from the USA, Japan, the EU, Australia/New Zealand and Canada. The USA, Japan and EU are the principal VICH members, while Australia/New Zealand and Canada have observer status at VICH. Observer members participate in the work of VICH, but do not vote at VICH meetings.

New Zealand and Australia represent both countries in rotation at VICH for a period of three years. Currently, Dr Peter Holdsworth, CEO of the Animal Health Alliance (The Alliance) represents The Alliance, VMDA, AGCARM and ARPPA, while Mr Martin Holmes represents APVMA and NZFSA. Ms Debbie Morris will take over representation of APVMA and NZFSA during 2008.

What does VICH do?

The objectives of 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

• provide a basis for wider international harmonisation of registration requirements

• monitor and maintain existing VICH guidelines

• ensure efficient processes for maintaining and monitoring consistent interpretation of data requirements following the implementation of VICH guidelines

• provide technical guidance by means of a constructive dialogue between regulatory authorities and industry, enabling response to significant emerging global issues and science that impact on regulatory requirements within the VICH regions.

The jewels of the work of VICH are its guidelines. VICH has published 36 guidelines and is working on a further 11. All the guidelines are on the VICH website (http://www.vichsec.org/).

Guidelines cover topics in product quality, efficacy, safety, environmental safety and pharmacovigilance. There are specific guidelines for anthelmintics and biological products such as vaccines. Guidelines are developed by a rigorous process of initial drafting by an expert working group, public consultation and review by the VICH Steering Committee. Experts from Australia and New Zealand have been members of several of the expert working groups.

What are the benefits of VICH?

The VICH guidelines represent agreement between VICH members as to what data should be provided by applicants to regulatory authorities in support of applications for approval of a veterinary medicinal product. This means that all VICH members have agreed on an international standard for data which proves quality, safety or efficacy of a product. By following the VICH guidelines, an applicant could provide the same data dossier to regulatory authorities in any of the VICH member countries.

NZFSA and the APVMA have adopted all of the VICH guidelines that have been finalised so far.

Through their VICH membership, New Zealand and Australian regulatory authorities and industry help keep the veterinary medicinal approval process in step with the rest of the world.