News and Analysis

Tammy Newbold from DS InPharmatics explains that by adhering to harmonised CMC regulatory practices, veterinary medicine companies can expedite market entry. The CMC framework efficiently identifies necessary studies for global approval and provides a roadmap for development. She highlights challenges in aligning global CMC requirements due to a lack of preliminary phases in veterinary medicine. Newbold also stresses the importance of continuous education and regulatory expertise in maintaining global standards, she notes that despite fewer resources, the veterinary medicine sector can optimise its strategies through emerging fields like gene therapy.