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AgVetLink: Number 68, June 2008

VICH Update

Background

VICH, the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, is a programme aimed at harmonising technical requirements for veterinary product registration. It was officially launched in Paris in April 1996.

The organisation brings together the regulatory authorities and representatives from the USA, Japan, the EU, Australia/New Zealand and Canada. The USA, Japan and EU are principal members, while Australia/New Zealand and Canada have observer status. Observer members participate in the work of VICH, but do not vote at VICH meetings.

Guidelines

VICH produces guidelines that cover topics in product quality, efficacy, safety, environmental safety and pharmacovigilance. There are specific guidelines for anthelmintics and biological products such as vaccines. Guidelines are developed by a rigorous process of initial drafting by an expert working group, public consultation and review by the VICH Steering Committee. Experts from Australia and New Zealand participate in several of the expert working groups.

New Zealand endorsement

In the past New Zealand has endorsed the finalised VICH guidelines and accepted them as alternatives to New Zealand registration requirements in the appropriate areas.

Several guidelines are now ready for discussion/endorsement at the next AVMAC meeting (28 August). Any comments you have should be sent to us before this date (email Emma.Miles-Buckler @nzfsa.govt.nz).

Guidelines revised with no material changes from the existing version, so we will request AVMAC endorsement:

GL3 Stability testing (1) New drug substances and products
GL10 Impurities in new veterinary drug substances
GL11 Impurities in new veterinary medicinal products
GL28 Studies to evaluate the safety of residues of veterinary drugs in human food -carcinogenicity testing

Guidelines signed off by the VICH Steering Committee but there is no record of consideration by AVMAC. These will be for discussion and possible endorsement at the August AVMAC meeting:

GL38 Environmental impact assessment for veterinary medicinal products - phase II
GL27 Guidance for pre-approval information for registration of new veterinary medicinal products for food-producing animals with respect to antimicrobial resistance

GL36 Studies to evaluate the safety of residues of veterinary drugs in human food: general approach to establish a microbiological ADI

GL37 Studies to evaluate the safety of residues of veterinary drugs in human foods: repeat dose chronic toxicity testing

GL39 Specifications: test procedures and acceptance criteria for new veterinary drug substances and new medicinal products

GL40 Specifications: test procedures and acceptance criteria for new biotechnological/biological veterinary medicinal products

Guidelines at Step 4 that are being consulted on at present:

GL43 Target animal safety for pharmaceuticals
GL44 Target animal safety for veterinary live and inactivated vaccines
GL45 Quality: bracketing and matrixing designs for stability testing of new veterinary drug substances and medicinal products

The text of all of the guidelines can be found on the VICH website at http://www.vichsec.org/