New International Rules Target Sheep Parasite Drugs
Published Date: 6/24/2026
Notice
Summary
The FDA just released new guidance to help drug makers test worm-killing medicines for sheep in a way that’s accepted worldwide. This makes it easier and faster for companies to get their products approved, saving time and money. Sheep farmers, vets, and drug companies should pay attention to these updated rules starting June 24, 2026.
Analyzed Economic Effects
2 provisions identified: 2 benefits, 0 costs, 0 mixed.
Harmonized Testing for Sheep Dewormers
The FDA published final guidance (GFI #96; VICH GL13) on June 24, 2026 that gives study design recommendations specific to ovines (sheep). The guidance is intended to facilitate the universal acceptance of generated effectiveness data so it can fulfill national and regional requirements for anthelmintic drugs in animal species, including those used by regulatory agencies in the European Union, Japan, and the United States.
Guidance Allows Alternative Approaches
The FDA states the guidance represents its current thinking and is not binding. You may use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
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