CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General Recommendations June 2026

GUIDANCE DOCUMENT

• Docket Number: FDA-2022-D-1494
• Issued by: Center for Veterinary Medicine

The objective of this guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated effectiveness data to fulfill the national/regional requirements for anthelmintic drugs in veterinary species.  This guidance was prepared after consideration of the current national/regional requirements and recommendations for evaluating anthelmintic drugs in the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) regions. 

This guidance provides general recommendations for the design of effectiveness studies for anthelmintics, applicable to the most common veterinary species.  Additional guidance for individual species-specific recommendations is provided in Guidance for Industry (GFI) #95/VICH GL12 (bovine); GFI #96/VICH GL13 (ovine); GFI #97/VICH GL14 (caprine); GFI #109/VICH GL15 (equine); GFI #110/VICH GL16 (porcine); GFI #111/VICH GL19 (canine); GFI #113/VICH GL20 (feline); and GFI #114/VICH GL21 (chicken).

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