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Australia and New Zealand’s role in VICH

• Management group
• Role of members / contact details
• ANZ VICH procedure
• ANZ VICH experts/coordinators
• VICH benefits for ANZ

ANZ VICH Management Group

Establishment of ANZ VICH MG
Following the first meeting of the VICH in April 1996, the ANZ representatives in VICH decided to set up an organisation to implement the observer role that had been acquired with respect to the VICH SC.

Membership of ANZ VICH MG
(number of seats)

Industry representation:

• Chairman - also the VICH industry representative.
• Animal Health Alliance (1) - Australia - also acts as secretariat for the Committee.
• Agcarm (1) - New Zealand
• ARPPA (1) - New Zealand
• VMDA (1) - Australia

Regulatory Authority representation:

• Australian Pesticides and Veterinary Medicines Authority (1) - Australia.
• NZFSA (1) - New Zealand.
• Environmental Risk Management Authority (1) - New Zealand.

The ANZ VICH MG meets twice a year, in concert with the VICH SC meetings.

Role of ANZ VICH

• Provide an industry/government forum for the facilitation of ANZ input into the VICH process in areas such as:

• Nominating ANZ representatives to VICH and its Working Groups.
• Providing direction on issues as they arise to ANZ representatives on VICH.
• Identifying issues for presentation to VICH.
• Preparing position papers on VICH topics.
• Identifying local coordinators for specialist advice on VICH topics.

• Promote harmonisation of Australian and New Zealand regulatory requirements for animal health products in line with VICH recommendations and internationally recognised standards.
• Provide advice to the ANZ Registration Management Committee established by the Australian and New Zealand governments in 1997.
• Provide advice to industry and government as appropriate on international harmonisation of regulatory requirements for animal health products.
• Seek coordination of ANZ international activities relating to regulatory requirements for animal health products (eg Codex).

ANZ VICH - Roles of Members & Contact Details

The roles of the various members of the ANZ VICH MG are:

VICH Industry Representative:

• Acts as chairman of ANZ VICH MG.
• Represents ANZ industry interests at VICH meetings.

Animal Health Alliance (Australia):

• Provides Secretariat support to ANZ VICH MG.
• Represents Australian industry interests as relates to AHA members.
• Prepares industry position papers for VICH in conjunction with VMDA, Agcarm, and ARPPA for consideration by the ANZ VICH MG.
• Liaises with industry groups in other countries in conjunction with VMDA, Agacarm and ARPPA.

• Contact Details:
  Animal Health Alliance (Australia) Ltd
  Locked Bag 916
  Canberra, ACT 2601
  AUSTRALIA
  Phone: 61 2 6257 9022
  Fax: 61 2 6257 9055

• Email: heather.koch@animalhealthalliance.org.nz
  Website: www.animalhealthalliance.org.au/

VMDA

• Represents Australian industry interests as relates to VMDA members.

Agcarm:

• Represents New Zealand industry interests as relates to Agcarm members.

ARPPA

• Represents New Zealand industry interests as relates to ARPPA members.

• Contact Details:
  ARPPA
  C/o Gabrielle Deuss
  Paekakariki Hill Rd
  Pauatahanui
  RD 1
  Porirua
  NEW ZEALAND
  Phone: 64 4 237 5085
  Email G.Deuss@xtra.co.nz

Australian Pesticides and Veterinary Medicines Authority:

• Represents the APVMA and APVMA advisory agency interests.
• Provides advice on Australian regulatory requirements relating to chemistry, residues, trade and efficacy.
• Facilitates use of requirements based upon VICH decisions and approved recommendations of ANZ VICH, where appropriate.
• Provides advice to the Australian government on VICH activities and decisions.
• Provides a regulatory perspective on issues for position papers for VICH, in conjunction with the New Zealand MAF Food Assurance Authority for consideration by ANZ VICH MG.
• Liaises with government regulatory bodies in other countries.
• Represents ANZ government interests at VICH meetings.

NZFSA:

• Represents New Zealand government regulatory interests, especially with respect to trade in primary produce, animal welfare and agricultural security matters, and compliance with domestic food residue standards.
• Provides advice on New Zealand regulatory requirements.
• Seeks changes to New Zealand regulatory requirements based upon VICH decisions, and approved recommendations of ANZ VICH MG.
• Provides advice to the New Zealand government on VICH activities and decisions.

Environmental Risk Management Authority (ERMA New Zealand):

• Represents New Zealand government regulatory interests, especially with respect to the health and safety of people and the environment.
• Provides advice on New Zealand regulatory requirements.
• Where appropriate seeks to harmonise New Zealand regulatory requirements with VICH decisions, and approved recommendations of ANZ VICH MG.
• Provides advice to the New Zealand government on VICH activities and decisions.

ANZ VICH Procedure for Input into VICH Working Groups
(equivalent VICH steps are in brackets)

Step a: Working Group topic is agreed by the VICH Steering Committee (Step 1).

Step b: ANZ VICH MG seeks nominations for Expert/Coordinator for the Working Group.

Step c: ANZ VICH MG agrees on nomination of Expert and submits to VICH SC. Where no Expert is nominated, a local Coordinator is agreed.

Step d: VICH SC establishes membership of Working Group and agrees on Chairman (Step 1).

Step e: In conjunction with the Expert/Coordinator, ANZ VICH MG identifies peer group (persons from Industry and Government).

Step f: Expert develops ANZ position paper in conjunction with peer group and submits paper to Working Group after sign-off by ANZ VICH MG.

Step g: Expert attends meetings of Working Group.

Step h: Working Group circulates draft for comment (Step 4).

Step i: Expert/Coordinator collates comments in relation o draft and prepares ANZ response for sign-off by ANZ VICH.

(Steps f to i continue until a final document is agreed by ANZ VICH MG)

Step j: ANZ response is submitted to the Working Group (when ANZ has an Expert) or to VICH SC (when there is a local Coordinator).

ANZ VICH Experts/Coordinators

There are two participating roles in VICH Working Groups - Experts and Coordinators. While the Experts interact directly with the appropriate VICH Working Groups, the Coordinators act locally by coordinating an ANZ position on VICH guidelines when an ANZ Expert has not been nominated.

Roles of Experts

• Act as the central liaison point for all written and oral communication in relation to the Working Group.
• Consult with peers in Australia and New Zealand (Industry and Government), from a listing developed in conjunction with ANZ VICH MG.
• Prepare de novo an ANZ submission to the Working Group, which incorporates the views of Industry and Government.
• Consolidate responses within ANZ on guidelines and provide recommendations for submission to the Working Group.
• Provide ANZ VICH MG with appropriate comment on the Working Group deliberations and decisions.
• Attend meetings of the Working Group as the ANZ representative.
• As appropriate, attend meetings of ANZ VICH MG to report on the Working Group activities.
• Obtain ANZ VICH MG approval for documents to be submitted to the Working Group.

Roles of Coordinators

• Liaise with the ANZ VICH Secretariat for all communications with VICH in relation to the Working Group.
• Act as the central liaison point for all written and oral communication in relation to the Working Group documents received through ANZ VICH MG.
• Consult with peers in Australia and New Zealand (Industry and Government), from a listing developed in conjunction with ANZ VICH MG.
• Prepare the ANZ submission to VICH, which incorporates the views of Industry and Government.
• As appropriate, attend meetings of ANZ VICH MG to report on the Working Group activities.
• Obtain ANZ VICH MG approval for documents to be submitted to the Working Group.

VICH - Benefits for Australia and New Zealand

Regulatory Certainty

• Uniform requirements.
• Predictable regulatory environment.
• Time limits for regulatory process.
• Economics of scale.
• Scientific principles rather than socio-economic considerations the mainstay of the approval process.

Reduced Animal Testing

• Elimination of duplicate testing.
• Introduction of uniform in vitro testing methods.

Ready-Made Model

• ICH model offers framework for harmonisation.
• Adapts human pharmaceutical work to veterinary sector.
• Complements work of Codex and JECFA.

Removal of Trade Barriers

• Harmonisation leads to increased free trade.
• Applies to both veterinary and food products.
• Observer countries are major food exporters.

Consumer Safety

• Requirements based on scientific principles reinforce credibility of regulatory process and food standards.
• Transparent and uniform process improves consumer perceptions of and confidence in food safety.

Broader Harmonisation

• Extends EU/US/Japan harmonisation initiatives.
• Participation in VICH promotes regional harmonisation.

Cost Efficiencies

• Avoids duplication.
• Reduction in R&D expenditure.
• Reduction in R&D timeframes
• Development of drugs with limited market potential.