VICH/05/039
27 May 2005
More than 170 delegates, from the USA, Japan and the EU, as well as from Australia, New Zealand, Canada and many other countries in the world attended the third VICH conference on May 26 & 27 in Washington DC. 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 Lester Crawford, US Food and Drug Administration Acting Commissioner, pointed out in his welcome address that, in an ever-shrinking world, the International Harmonisation through VICH, was an essential asset for the improvement of Animal Health and Welfare as well as Food Safety and Public Health. “VICH is a unique opportunity for governments and industry from around the globe to work together on common goals” said Dr Crawford, and furthermore he added: “FDA is committed to the continued work of VICH to achieve harmonised Guidelines for all regulatory requirements where significant differences exist among the participating regions”.
Keynote speaker Mr Pedro Lichtinger, President of Pfizer Animal Health and President-elect of IFAH, the International Federation of Animal Health, highlighted the utmost importance of international harmonisation through VICH for the research based Animal Health Industry developing new products in a sustainable global market. “VICH has been for this Industry a key strategic initiative since its creation 9 years ago” said Mr Lichtinger. He went on saying: “We need a regulatory environment that encourages innovative Research and Development and our Industry therefore supports the process, the philosophy and the transparency of VICH”.
The conference marked the conclusion of the first phase of the VICH programme and all regions confirmed their commitment as the pivotal key element for continued success of VICH.
The participants to the conference applauded the hard work and achievements of the more than 120 of the world’s leading experts who have negotiated and prepared numerous guidelines since the start of VICH in 1996. In the different fields of product Safety, Quality and Efficacy, 33 guidelines have already been adopted and mostly implemented in the 3 regions and the observer countries, whilst 11 further documents are being prepared.
The VICH3 conference sessions provided an opportunity for the participants to obtain detailed information on the processes and scientific rationale for achieving the harmonised VICH Guidelines in the fields of Quality, Safety, Ecotoxicity, Biologicals Quality Monitoring, Pharmacovigilance, Target Animal Safety and Antimicrobial Resistance, and to discuss them with the experts.
In presenting the strategy for the second phase of activity of VICH, Dr Patrick Dehaumont, representing OIE, reinforced OIE’s continuous support of all VICH activities with particular aim of protecting Animal Health and Public Health.
In closing the conference, Dr Stephen Sundlof, Director of the Center for Veterinary Medicine of the US Food and Drug Administration, congratulated VICH for the progress achieved within a few years, and encouraged the Steering Committee to maintain the momentum of the work already completed.
AHI, FDA and USDA were applauded for the outstanding organisation of this successful event.
The VICH Steering Committee held its 16th meeting in Washington DC around the Conference and adopted a new Workplan for the forthcoming years, thus confirming the move to the 2nd phase of the VICH process. This Workplan implements the new VICH strategy for the revision and updating of adopted Guidelines at step 9 of the VICH procedure, where necessary, due to new scientific developments or requirements.
A milestone was achieved when the Steering Committee signed off the first revised VICH Guidelines at step 4: Revised VICH draft GL 10 (Quality – Impurities in New veterinary drug substances) and Revised VICH draft GL 11 (Quality – Impurities in New veterinary medicinal products), which were released for a 3 months public consultation period.
The Steering Committee decided to establish a new VICH Expert Working Group on Metabolism and Residue Kinetics chaired by the EU.
The Steering Committee noted the progress achieved by the Pharmacovigilance Expert Working Group which resolved most outstanding issues regarding the following VICH draft Guidelines:
· VICH Draft GL 24 (Pharmacovigilance – Pharmacovigilance of veterinary medicinal products: management of Adverse Event Reports (AERs)),
· VICH Draft GL 29 (Pharmacovigilance – Pharmacovigilance of veterinary medicinal products: management of Periodic Summary Update Reports (PSURs)),
· VICH Draft GL 30 (Pharmacovigilance – Pharmacovigilance of veterinary medicinal products: controlled list of terms)
· VICH Draft GL 35 (Pharmacovigilance – Electronic Standards for Transfer of Data).
The Steering Committee reviewed the work of the Expert Working Groups on Quality, Biologicals Quality Monitoring and Target Animal Safety, and acknowledged that the latter aims to sign-off within the next months by written procedure 2 new VICH draft Guidelines.
The 17th meeting of the Steering Committee is scheduled for 1 and 2 November 2005, in Kyoto (Japan).
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OIE: Office International des Epizooties/World Animal Health Organisation
AVBC: Association of Veterinary Biologics Companies (USA)
For further information, please contact the VICH Secretariat:
c/o IFAH, International Federation for Animal Health
Rue Defacqz, 1 - 1000
Brussels (Belgium)