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AgVetLink December 2002

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VICH update 

International conference and Steering Committee meetings

The second international conference for VICH was held in Tokyo from 9 to 11 October 2002. It was held in conjunction with a meeting of the Steering Committee and meetings of the active working groups. A total of 239 people registered for the conference; 110 of these were from Japan.

There was no significant presence outside of the Asian region apart from members of the Steering Committee, the working groups and speakers. Dr Bill Jolly, the New Zealand Veterinary Counsellor in Brussels, was one of the keynote speakers.

Debbie Morris, Director of the ACVM Group, took over as the Australia New Zealand regulatory representative on the steering group following the completion of the Steering Committee meeting. John Reeve is a member of the Safety working group which met on 7 and 8 October. Brian Pidford also attended the conference - Brian was a member of the working group on Good Clinical Practices which has completed its work but will review the standards at some stage in the future. Also in attendance were Alison Turner of the NRA and Peter Holdsworth representing the ANZ Industry Groups. Jack Holland and Fred Bover (both working group members from Australia) were also at the conference.

A meeting of the regulators in advance of the Steering Committee was held on 7 October (and a similar one for the industry representatives). Canada was in attendance for the first time as an observer.

The Steering Group agreed the adoption of GL 31, 32, 33 and 28 at step 6 with 12 months to implement them. The Guidelines (both those that have been adopted and those for consultation) and details of the VICH process are available on the NZFSA website at http://www.nzfsa.govt.nz/policy-law/vich/index.htm

A number of possible new topics were discussed:

• the revision of GL10 and 11 could not be progressed as the United States is unable to allocate resources;
• a paper on Biologicals quality stability testing was tabled on the day and cannot be considered until the next meeting;
• the paper from the EU on Metabolism and residue kinetics will be discussed at the next Steering Committee meeting.

The next Steering Committee meeting is to be held (7 - 8 May 2003) in London followed by a meeting (7 - 8 October) in Washington. The VICH 3 conference will be in the USA (somewhere around the Washington region) in 2005.

New Zealand endorsement of VICH guidelines

At the AVMAC meeting on 21 November 2002 the following VICH guidelines were endorsed:

GL15 Anthelmintics - equine: Efficacy requirements for anthelmintics: specific recommendations for equines. (July 2002) 

GL16 Anthelmintics - swine: Efficacy requirements for anthelmintics: specific recommendations for swine. (July 2002) 

GL19 Anthelmintics - canine: Efficacy requirements for anthelmintics: specific recommendations for canine. (July 2002) 

GL20 Anthelmintics - feline: Efficacy requirements for anthelmintics: specific recommendations for feline. (July 2002) 

GL21 Anthelmintics - poultry: Efficacy requirements for anthelmintics: specific recommendations for poultry. (July 2002) 

GL22 Safety reproduction: Studies to evaluate the safety studies for veterinary drug residues in human food: reproduction testing studies. (August 2002)  

GL23 Safety genotoxicity - studies to evaluate the safety studies for veterinary residues in human food: genotoxicity testing studies (August 2002)

GL25 Biologicals: Formaldehyde - testing of residual formaldehyde (May 2003) 

GL26 Biologicals: Moisture - testing of residual moisture (May 2003).

AVMAC will be copied the final version of the following guidelines along with a proposal for New Zealand endorsement at the next meeting in February 2003:

GL28 Safety studies for veterinary drug residues in human food: Carcinogenicity studies. (October 2003)* 

GL 31 Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat dose (90 days) (October 2003)* 

GL32 Studies to evaluate the safety of residues of veterinary drugs in human food: Developmental toxicity testing. (October 2003)* 

GL33 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to testing (October 2003)* 

In addition, the following guidelines are at Step 4 (for consultation):

GL24 Pharmacovigilence: Adverse experience reports.

GL27 Antibiotic resistance: Pre-approval information for registration of new veterinary medicinal products: controlled list of terms.

GL29 Pharmacovigilence: Management of periodic safety update reports.

GL30 Pharmacovigilence: Controlled list of terms.

GL34 Testing for detection of mycoplasma contamination.

The NZFSA proposes to apply these Step 4 guidelines (as appropriate) in its standards and guidelines for the registration of veterinary medicines under the ACVM Act, and in any related legislation. We will take into account any changes made through consultation in the final documents.

* Hard copies of these guidelines will be circulated at the meeting.

MRL update

Discussion paper 05/02 Proposed New Zealand (Maximum Residue Limits of Agricultural Compounds) Food Standard 2002 completed its consultation period on 29 October 2002.

The document proposed to establish a new maximum residue limit (MRL) for a specified agricultural compound (Spinosad) in stonefruit. It also covered some 'housekeeping' changes to the MRL standard to consolidate the seven amendments that have been made since 1999, in order to reflect recent changes in the legislative framework around food and agricultural compounds regulation, and to correct miscellaneous inconsistencies.

The NZFSA Policy team is working with MAF Legal to finalise the standard in the near future. The next MRL discussion document is expected in December. Because of the Christmas break, there will be a six-week consultation period rather than the usual three weeks.