VICH/02/061
12 October 2002
PRESS
RELEASE
International
Conference moves forward global standards
for Animal Health Products
About
200 delegates, from Japan, the USA and EU member States and accession countries,
as well as from Australia, New Zealand, Canada and many other countries in the
world met in Tokyo this week at the second 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.
Dr
Shunichi Ijichi, Director of the Animal Health Division in the Japanese Ministry
of Agriculture, Forestry and Fisheries, acknowledged in his welcome address that
the public interest in Animal Health and Veterinary Medicinal Products is
growing globally, thus the increasing significance of a steady and speedy
progress of International Harmonisation, through VICH.
Dr Jim Pearson, representing OIE Director General Bernard Vallat, “believes that the expected benefits from VICH are realistic and that they will improve animal health” and confirmed OIE’s commitment to continuing to support VICH.
Since
the start of VICH in 1996, more than 100 of the world’s leading experts have
negotiated and prepared numerous draft and final guidelines in the different
fields of product Safety, Quality and Efficacy. 25 guidelines have already been
adopted and mostly implemented in the 3 regions, whilst 5 are at the end of the
consultation period and 4 under consultation. Further documents are being
prepared within the 6 currently active Expert Working Groups
The
VICH2 conference breakout sessions provided an opportunity for the participants
to meet with numerous experts and discuss the scope and the requirements of VICH
Guidelines in the fields of Quality, Safety, Ecotoxicity, Biologicals Quality
Monitoring, Efficacy of Anthelmintics, Pharmacovigilance, Antimicrobial
Resistance and Target Animal Safety.
Participants
agreed that VICH is today more important than ever before in order to facilitate
the global registration of Veterinary Medicinal Products, whilst establishing
and maintaining consumer confidence in the Quality, Safety and Efficacy of these
products. Animal welfare and consumer safety are of paramount importance to
modern society at the beginning of the 21st century.
Keynote
speaker Dr Bill Jolly, New Zealand Ministry of Agriculture and Forestries,
called for a harmonised, risk-based and outcome-focused registration system, in
which mutual recognition of the equivalence of regulatory systems and increased
cooperation and sharing of assessments are the keys to success.
In closing
the conference, Dr Stephen Sundlof, Director of the Center for Veterinary
Medicines of the US Food and Drug Administration, congratulated VICH for the
progress achieved within a few years, and invited all the participants to attend
the VICH3 conference in the USA in Spring 2005. Dr Sundlof encouraged the
participants to address the remaining challenges.
JVPA,
JAVB and JMAFF were praised for the outstanding organisation of this successful
event.
The
VICH Steering Committee held its 11th meeting in Tokyo around the Conference and
signed-off four Guidelines at step 6:
·VICH GL 28 - Safety of Residues of Veterinary Drugs in Human Food –
Carcinogenicity Testing,
·VICH GL 31- Safety of Residues of Veterinary Drugs in Human Food –
Repeat-Dose (90 days) Toxicity Testing,
·GL 32 - Safety of Residues of Veterinary Drugs in Human Food – Developmental
Toxicity Testing,
·GL 33 - Safety of Residues of Veterinary Drugs in Human Food – General
Approach to Testing.
These Guidelines were released for implementation in the 3 regions by October
2003, with the exception EU implementing GL 32 at a later date.
The 12th meeting of the Steering Committee is scheduled for 7 and 8 May 2003 in London, Europe.
OIE:
International Office of Epizootics
For
further information, please contact the VICH Secretariat:
c/o
IFAH, International Federation for Animal Health
Rue Defacqz, 1 - 1000 Brussels (Belgium)
Phone: +32-2-5410111, fax: +32-2-5410119,
E-mail: vich@ifahsec.org , Website: http://vich.eudra.org