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VICH update

Food Safety Working Group

In December 2001, the VICH Food Safety Working Group met in Tokyo to further the establishment of harmonised toxicology data requirements for supporting veterinary medicines used in food producing animals.

Step 3 sign offs
Draft guidelines for repeat-dose (90-day) and developmental toxicity studies, plus the general approach to testing, were signed off at step 3.

When approval to consult formally on these documents has been received from the VICH Steering Group, the drafts will be circulated and responses collated so that formal New Zealand and Australian comments can be made.

Repeat-dose (chronic) studies
The draft guideline for repeat-dose (chronic) studies has not yet reached an agreed draft. The discussions continue as to the appropriate length of these studies. Europe and the US believe that all should be known about a substance being tested after no more than one year (and maybe an even shorter period), while Australia and Japan require convincing that studies shorter than two years would give the required level of assurance to a regulatory authority.

New Zealand is neutral in this debate – while we also believe that studies shorter than two years should give proper assurance as to long-term toxicity of a substance, we are required to represent both New Zealand and Australia at the meeting.

Pharmacovigilance

The VICH Pharmacovigilance topic is in a critical state and its continuation is in doubt. A recent phone conference was held by MAF, the NRA, Peter Scott (Merial) as the Australia/New Zealand topic expert, Sarah Weston (Bayer) for AGCARM and ARPPA, and Peter Holdsworth for AVCARE to determine the Australia/New Zealand position. Peter Scott provided background.

Expedited global reporting issue
One main issue of dissension concerns the global distribution of expedited reports of critical adverse events. This is a European regulatory requirement and the EMEA position is that harmonisation must be based on the EC process because the European legislation will not be changed.

The US (AHI) and EC (FEDESA) industries' position on expedited global reporting is that the EMEA requirements are excessive, will entail greatly increased costs, and that harmonisation should involve the willingness of all parties to accommodate a mutually acceptable outcome, not just the adoption of the highest standard of a particular party.

AHI and FEDESA have requested the VICH Steering Committee to intercede with the EMEA to modify its position on expedited global reporting, and that, if that does not occur, require the closure of this harmonisation topic.

The FDA position is understood to be that it believes it has the flexibility to accommodate a harmonised pharmacovigilance process under its legislation.

The Japanese response has been to request cancellation of the next working group meeting scheduled for April 2002, and the assumption is being made that Japan will seek closure of the topic at the next VICH meeting in Japan in October 2002.

The Australia/New Zealand position is that while MAF and the NRA are considering changes to improve the reporting of adverse events, the EMEA requirement for global distribution of expedited adverse event reports is excessive.

Periodic summary updates
A second, and lesser issue, of industry concern relates to the provision of periodic summary updates (PSU), and the complexity and frequency of reporting that may be required.

With regard to the issue of the PSU, the guideline has been signed off at VICH step 4. Both MAF and the NRA believe improvements to adverse event reporting can be introduced regionally under existing legislation that will be compatible with the guideline, but will be less demanding than the EC prescriptive requirements.

Biologicals Quality Monitoring

The VICH Working Group on Biologicals Quality Monitoring is progressing its assignments on schedule and has just completed a guideline at step 2 on 'Test for the Detection of Mycoplasma Contamination'. (Copies are available from the ACVM Group. Please contact Brian Pidford: pidfordb@maf.govt.nz).