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International harmonisation of anthelmintic efficacy guidelines.

J Vercruysse¹, P Holdsworth, T Letonja

¹Department of Parasitology, Faculty of Veterinary Medicine, Ghent University, Salisburylaan 133, B9820, Merelbeke, Belgium.

Veterinary Parasitology

|March 10, 2001

Summary

The International Co-operation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) established guidelines for anthelmintic efficacy. These VICH guidelines aim to improve access to safer, more effective veterinary medicines for livestock.

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Area of Science:

Veterinary Pharmacology
Regulatory Science
Animal Health

Background:

The International Co-operation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) is a collaborative initiative.
Regulatory authorities and animal health industries from the EU, Japan, and USA collaborate to harmonize veterinary medicinal product registration.
Australia and New Zealand actively observe VICH proceedings.

Purpose of the Study:

To present the established guidelines by the VICH working group on Anthelmintic Efficacy.
To outline general requirements and specific recommendations for anthelmintic efficacy in bovines, ovines, and caprines.

Main Methods:

Development of VICH Anthelmintic Efficacy Guidelines (GL7, GL12, GL13, GL14).

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Focus on harmonizing technical requirements for veterinary medicinal product registration.

Establishing minimal standards for anthelmintic efficacy.

Main Results:

Publication of four key guidelines: VICH GL7 (General Requirements), VICH GL12 (Bovines), VICH GL13 (Ovines), and VICH GL14 (Caprines).
Guidelines provide clear recommendations on minimal standards, not rigid stipulations.
Harmonization is expected to streamline the registration process.

Conclusions:

Harmonized guidelines facilitate quicker access to safer and more effective veterinary anthelmintics.
Reduced registration costs and efficient resource utilization are anticipated.
Benefits extend to veterinary professionals, livestock producers, and animal owners.