Table of Contents
The World Association for the Advancement of Veterinary Parasitology (WAAVP) is a not-for-profit organisation for scientists who study the parasites of non-human animals. The guidelines, developed by the international expert working groups of the WAAVP, assist in the international harmonisation of standards and procedures for the evaluation of veterinary parasiticides. The WAAVP guidelines for evaluating the efficacy of ectoparasiticides on ruminants aim to standardise the minimum set of data that should be submitted to demonstrate the efficacy of new ectoparasiticides for use on or in ruminants.
The APVMA has adopted the WAAVP guidelines for evaluating the efficacy of ectoparasiticides on ruminants to assist registration holders in the conduct of regulatory trials. The APVMA notes that in some instances the WAAVP guidelines advise consultation with the regulator. We also recognise that because of Australia’s unique environmental and geographic parameters, parasite burdens and their population dynamics, farm management practices and animal breeds, there are some differences between the WAAVP guidelines and the APVMA’s recommendations for efficacy trials for products to be registered in Australia. Therefore, applicants should conduct efficacy trials within Australia under typical farm management practices covering relevant geographical regions and the following additional guidance is provided to assist you in conducting these trials. If you follow this additional guidance, your data should generally be sufficient for the APVMA to assess its confidence in the product’s efficacy given Australia’s unique conditions.
This preamble refers to the following World Association for the Advancement of Veterinary Parasitology (WAAVP) guideline: Vercruysse, J, Rehbein, S, Holdsworth, PA, Letonja, T & Peter, R 2006, ‘World Association for the Advancement of Veterinary Parasitology (WAAVP) guidelines for evaluating the efficacy of ectoparasiticides against (mange and itch) mites on ruminants’, Veterinary Parasitology, vol. 136, pp. 55–66.
1. Definition of claims
The WAAVP guidelines refer to ‘therapeutic efficacy’. In the interests of clarity and consistency for new and existing registered products, the APVMA will use the term ‘control’ and not ‘therapeutic efficacy’.
With respect to Psorergates ovis, ‘control’ is defined as: ‘Reduction of the mite population to non-detectable levels at all post-treatment examinations of treated sheep, in the presence of normal seasonal fluctuations in the population on untreated sheep kept under the same conditions’.
2. Wool or hide damage
Given the importance of the wool and cattle by-product industries to Australian commerce, it is recommended that applicants collect and submit data on wool staining or damage, hide or skin damage, or damage to animal products.