VICH/99/120

19 November 1999

***PRESS RELEASE***

# VICH1 participants applaud impressive progress in international harmonisation

Over 280 delegates, from countries as far a field as Saudi Arabia, South
Africa, Mexico and New Zealand met in Brussels this week at the first
VICH conference. VICH is an international cooperation programme set up
between Japan, EU and the USA to develop international guidelines for
the registration of veterinary medicinal products. Australia and New
Zealand also participate as observers.

The spokesman of HRH Prince Laurent of Belgium said at the welcome
reception to the conference that VICH had an important contribution to
offer in the worldwide reduction in the use of experimental animals. The
conference was opened by Dr. Jean Blancou, Director-General of OIE. He
commended VICH members on succeeding agreement on areas such as:

-   Duration and condition for stability tests

-   Levels and testing requirements for impurities

-   Initial environmental impact assessment (phase 1), including
    thresholds for the need for more sophisticated fate and exposure
    studies

-   A complete guide for integrating quality approach into clinical
    trials (GCP)

-   Design of dose-determination and dose-confirmation studies for
    anthelmintics

-   Requirements for testing the efficacy of anthelmintics in each
    animal species

These agreements are consigned in a set of 12 guidelines developed
during the first three years of the VICH process.

This was echoed by Dr. Boisseau, Head of the OIE Collaborating Center
for Veterinary Drugs, who chaired the VICH Steering Committee for the
first 3 years of VICH. "The conference was a unique opportunity for
everyone to have their say on priorities for future international work"
stated Dr. Boisseau.

Among these priorities for future work, VICH will be discussing certain
registration requirements of antibiotics through a new working party.

"Antibiotics and the potential transfer of resistant organisms to human
is a very topical issue in all member countries" said Dr. Jacques
Boisseau, Chair of the VICH Steering Committee. "The new working group
will have a difficult but very important job to do in establishing new
guidelines that are acceptable to regulatory authorities" he said.

Mr. Jörn Keck, Deputy Director-General of the Directorate-General for
Enterprise at the European Commission, also welcomed the progress made
in reaching this important milestone, which will "benefit consumers
everywhere\", and \"looked forward with confidence to the next phase of
VICH."

Mr. Alex Thiermann, Senior Trade Coordinator from US Department of
Agriculture, and recent past Chairman of the WTO SPS Committee,
commented on the role that harmonisation initiatives, such as VICH, have
in reducing potential barriers to trade.

Keynote speaker John Preston, Chairman of Merial, said that
\"international harmonisation was a tremendous opportunity to reinforce
and restore confidence in science-based decisions and address the crisis
of confidence in the safety of the animal food supply chain".

Dr. Alison Turner, CEO of the Australian National Registration
Authority, in her address, reflected that "VICH provided the opportunity
to access the best experience in the world, leading to quality
guidelines that minimised unnecessary animal testing and contribute to
consistent product standards."

The VICH conference provided an opportunity for participants to review
progress and make comments on specific guidelines and the VICH process
in general.

Interest was strong -- many comments focussed on how non-VICH
participants could comment on guidelines under development, recognising
their potential international impact, and they encouraged even greater
transparency in the VICH process.

In closing the conference, Mr. Norio Hirayama, the Chief of the Second
Assay Division in Japanese MAFF, recognised "the achievements of VICH in
bringing together industry and regulatory agencies from countries with
different cultures, languages and customs." Dr. Michael McGowan from the
US Animal Health Institute acknowledged "the major benefits that will
accrue to industry from common data requirements in the VICH regions, as
well as facilitating the availability of new innovative veterinary
products."

FEDESA, the European Federation of Animal Health, was praised for
organising this top-class event, facilitating contacts and interactions
between all delegates.

# Seven new guidelines adopted at 6^th^ VICH Steering Committee

The Steering Committee\* of the VICH (International Cooperation on
Harmonisation of Technical Requirements for Registration of Veterinary
Medicinal Products) held its 6^th^ meeting in the margins of the VICH
conference, on 15, 16 and 19 November. The meeting was chaired by Dr. J.
Boisseau, Head of the OIE Collaborating Centre for Veterinary Drugs.

The Steering Committee adopted 7 final VICH guidelines:

-   GL7 - Efficacy of anthelmintics: general requirements

-   GL8 - Stability testing for medicated premixes

-   GL10 - Impurities in new veterinary drug substances

-   GL11 - Impurities in new veterinary medicinal products

-   GL12 - Efficacy of anthelmintics: specific recommendations for
    bovines

-   GL13 - Efficacy of anthelmintics: specific recommendations for
    ovines

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-   GL14 - Efficacy of anthelmintics: specific recommendations for
    caprines

These guidelines are scheduled to enter into force in November 2000,
with a maximum possible extension of the implementation date until May
2001.

It also released 3 guidelines for consultation at step 4:

-   GL15 - Efficacy of anthelmintics: specific recommendations for
    equines

-   GL16 - Efficacy of anthelmintics: specific recommendations for swine

-   GL19 - Efficacy of anthelmintics: specific recommendations for
    canine

The Steering Committee reviewed the progress of the Working Groups on
Quality, Safety, Good Clinical Practices, Anthelmintics Efficacy
Requirements, Environmental Impact Assessment, Biologicals Quality
Monitoring and Pharmacovigilance.

Based on a strategic plan agreed at its last meeting, the Steering
Committee discussed the working plan for 2000-2003 and agreed a number
of fundamentals regarding its functioning and future work. As a
short-term item, it endorsed the creation of 2 additional working groups
on the following topics:

-   Antimicrobial resistance (to be chaired by the EU)

-   Target Animal Safety (to be chaired by JVPA/JAVB)

The mandate of the antimicrobial resistance Working Group is to
elaborate requirements on pre-approval studies needed to predict the
potential of antimicrobials to develop resistance, and on labelling
requirements related to the prudent use of these products.

The 7^th^ meeting of the Steering Committee was scheduled for 14-16 June
2000 in Tokyo, Japan.

\_\_\_\_\_\_\_\_\_\_\_\_

**\* Members of the Steering Committee**

EU: European Commission - European Agency for the Evaluation of
Medicinal Products

JMAFF: Japanese Ministry of Agriculture, Forestry and Fisheries

USA: US Food & Drug Administration -- Center for Veterinary Medicine
(CVM) and US Department of Agriculture -- Center for Veterinary
Biologics (USDA/CVB)

AHI: US Animal Health Institute

FEDESA: European Federation of Animal Health

JVPA-JAVB: Japanese Veterinary Pharmaceutical Association -- Japanese
Association of Veterinary Biologics

**\*Observers**

Australia/New Zealand: National Registration Authority
(Australia)/Ministry of Agriculture and Forestry (New Zealand)

AVCARE/AGCARM: National Association for Crop Production & Animal Health
(Australia)/Agricultural Chemicals & Animal Remedies Manufacturers'
Association of New Zealand