Regulatory Science for Veterinary Therapeutic Innovation: A Comparative Analysis of Drug Development Incentives Within the One Health Framework.

Authors

Sungwoo Hong, Sang-Myeong Lee

Published in

Veterinary sciences. Volume 13. Issue 10. Oct 20, 2026. Epub Oct 20, 2026.

Abstract

Rapid advances in antiviral therapeutics, targeted biologics, RNA medicines, and precision veterinary medicine are generating unprecedented scientific opportunities for veterinary healthcare, yet translation of these innovations into approved veterinary products remains disproportionately slow. This review employs a comparative regulatory science framework to identify the regulatory and economic determinants of this innovation gap across four jurisdictions-FDA-CVM (US), EMA-CVMP (EU), PMDA/MAFF (Japan), and APVMA (Australia)-and to compare existing incentive instruments and identify the regulatory gaps between them. Two illustrative case studies, GS-441524 for feline infectious peritonitis and canine osteosarcoma therapeutics, illustrate how the absence of breakthrough pathways, limitations in the practical translation of Minor Use/Minor Species (MUMS) eligibility, and unresolved intellectual property barriers can suppress development investment. The multi-jurisdictional analysis indicates that this innovation gap is evident across the jurisdictions examined and is consistent with differences in the availability and strength of regulatory incentives, though scientific and market factors likely also contribute. Policy reforms are proposed, including a Veterinary Breakthrough Drug Designation, a One Health Innovation Designation with enhanced exclusivity, adaptive regulatory pathways, and strengthened VICH harmonization. Additionally, the regulatory preparedness for advanced veterinary therapeutics-including gene therapies, mRNA-based vaccines, and cell-based products-is examined as a critical frontier. The analysis highlights the role of regulatory science in translating emerging veterinary therapeutics into clinical practice within the One Health framework.

PMID:
42944213
Bibliographic data and abstract were imported from PubMed on 27 Oct 2026.

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