In this interview, News-Med talks to Tammy Newbold about the Global Harmonization of Regulatory CMC within Veterinary Medicine. Can you explain what global harmonization of regulatory CMC entails and why it is particularly significant in veterinary medicine? Global harmonization is very important for veterinary medicine because the field is smaller and often has limited resources compared to human health. Startups in veterinary medicine usually do not receive as much funding as human pharmaceutical companies.
Although this is changing, with some startups receiving substantial funding, efficient drug development is still vital. By adhering to harmonized CMC regulations, they can expedite market entry and approval, maximizing their limited resources. Global harmonization ensures that when companies enter their first market, such as the US or Europe, they have already considered the regulatory requirements of the other market.
This means that entering the second market is easier because they have already completed most of the necessary studies, making the transition more efficient and cost-effective. The process works under a global harmonization development program, minimizing the time and money spent expanding into new markets. How does the regulatory CMC framework influence the development and approval of new veterinary medicines? The regulatory CMC framework sets the foundation for developing new veterinary medicines.
Development of veterinary medicines moves much faster tha.