International harmonisation of Anthelmintic Efficacy Guidelines

The "International Go-operation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH)" is an internation al programme of co-operation between regulatory authorities and the animal health industries of the European Union, Japan, and the United States of Am erica which aims to harmonise the technical requirements for the registrati on of veterinary medicinal products. Australia and New Zealand participate as active observers. The objective of the present paper is to present the g uidelines established by the working group on Anthelmintic Efficacy Guideli nes: (1) efficacy of anthelmintics: general requirements (VICH GL7); (2) ef ficacy of anthelmintics: specific recommendations for bovines (VICH GL12); (3) efficacy of anthelmintics: specific recommendations for ovines (VICH GL 13); (4) efficacy of anthelmintics: specific recommendations for caprines ( VICH GL14). These guidelines do not consist of rigid stipulations, but make clear recommendations on the minimal standards needed. To the veterinary p rofession, livestock producers and animal owners, harmonisation should mean quicker access to safer and more effective veterinary anthelmintics. In ge neral, products should be relatively more affordable because of the reducti on in registration costs and efficient use of resources by the regulatory a uthorities. (C) 2001 Elsevier Science B.V. All rights reserved.