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AgVetLink June 2004: Page 7

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VICH

Steering Committee meeting

The 14th Steering Committee (SC) meeting was held in Tokyo, Japan, in May. As has become normal practice, the SC meeting was preceded by a half day meeting of the regulatory parties and a meeting of the industry parties. The main result of the regulators’ meeting was the initiative taken by Ian Alexander of the Veterinary Drugs Directorate in Canada to facilitate a meeting to attempt to resolve the issues around the pharmacovigilance guidelines (see page 8). For those interested in this issue, the VICH papers are on the website (http://www.nzfsa.govt.nz/policy-law/vich/guidelines/index.htm).

At the main meeting there was discussion about plans for the third VICH conference, which will be held in Washington 25 - 27 May 2005. A draft programme will be available soon.

There was also considerable discussion over the development of a strategy for the future of VICH. It has been agreed that the updating of guidelines is an important function now that there are over 30 guidelines implemented in the European Union, the United States, Japan, Canada, Australia and New Zealand. The SC is still looking at ways of linking effectively to ICH (the equivalent body for human drugs), and ensuring that there is no duplication of effort with other international standard setting bodies such as Codex.

One of the main points agreed is that the development of new guidelines remains a key function of VICH, but that much more effort must be put in at the early stages of development of the concept papers to do a realistic feasibility assessment. The industry groups have undertaken to do a ‘gaps analysis’ to show where efforts can best be directed in the future – no doubt Agcarm and ARPPA, as the New Zealand industry groups associated, will be looking at this as well.

The SC also reviewed a proposal for amending VICH GL 28 (Studies to evaluate the safety of residues of veterinary drugs in human food:

Carcinogenicity testing) and agreed to release this revised Guideline for a shortened two month consultation period at step 4, limited to the additional new text to the Guideline. Another milestone was achieved by the sign-off of the last two Safety Guidelines at step 6:

VICH Guideline 36 (General approach to establish a microbiological ADI), and VICH Guideline 37 (Repeat-dose [chronic] toxicity) for implementation by May 2005.

The Steering Committee congratulated the members and the chairman of the Expert Working Group (see article at right) for the successful drafting of 8 VICH Safety Guidelines and their commitment to this difficult task.

A meeting of the ANZ management group in late June will cover this and the other actions coming out of the last SC meeting and prepare for the next meeting in Berlin in October. In the interim there is a meeting of the strategy taskforce planned for mid July in Paris.

 

Expert Working Group

The Food Safety Expert Working Group was charged with agreeing on a harmonised toxicology data package that regulatory authorities would utilise for supporting applications for veterinary medicines used in food-producing animals. John Reeve, Programme Manager (Toxicology and Residues) of the ACVM Group, represented Australia and New Zealand.

The group met eleven times from April 1997 to completion of its mandate in March 2004. Full international harmonisation was achieved except for one aspect of the toxicology package – whether one or two long-term feeding studies should be required. Analysis of the reviews of all the substances that have been subject to regulatory scrutiny could not resolve this issue to the satisfaction of all countries represented, and the group was evenly split as to their requirements. New Zealand, USA and Europe accept one long-term study as part of the package (mainly on the grounds that very little extra information is obtained from a second study, and this group concluded that, because of animal welfare considerations, it was not a good use of animals to carry out a second study). Japan, Australia and Canada require two long-term studies unless a scientific argument can be provided to show only one is necessary (mainly on the grounds that extra information that could modify the conclusions from the studies could occasionally be obtained from a second study, even if only rarely).

The full members of the VICH (European Union, USA and Japan) will be required to adopt the harmonised package, and the observers (Australia, New Zealand and Canada) are also committed to its adoption. This will give certainty to proprietors wishing to register veterinary medicines for their major markets in terms of the production of the required toxicology dossier.

The group has achieved its success in a relatively short time and was able to resolve many issues because of the trust that built up amongst the delegates (both regulators and industry representatives). New Zealand, which was seen as politically neutral by the major participants (Japan, USA and Europe), was able to broker many solutions to impasses through its pragmatic, strictly scientific approach.