Quarantine Agency Approves Seven New Veterinary Drugs for Second Year in a Row, Reducing Import Dependence

Dedicated Review Team for New Veterinary Drugs Established in May 2024
Guidelines on Review Standards to Be Established Within the Year
Institutional Framework to Be Strengthened

The Animal and Plant Quarantine Agency announced on the 23rd that it has continued to support the development of new veterinary drugs for companion animals, for which on-site demand is surging, including the approval of seven new veterinary drugs last year.

An official from the Animal and Plant Quarantine Agency said, "The review of new veterinary drugs is conducted in a complex manner by item (safety, efficacy, and quality specifications). In the past, the veterinary pharmaceutical industry often experienced delays in market entry due to difficulties in preparing review data and designing clinical trials," adding, "In response, through the 'Dedicated Review Team for New Veterinary Drugs' established in May 2024, the agency has been providing tailored consulting throughout the entire new drug development process, including pre-consultations on the preparation of review data and strategies for clinical trial design. By doing so, we have enhanced the professionalism of the review process and strengthened support for the industry."

The Asia Business Daily DB

In particular, among the seven new veterinary drugs approved last year, two heart disease treatments for companion dogs developed by domestic manufacturers were included, demonstrating the development capabilities of domestic companies in a companion animal pharmaceutical market that had been highly dependent on imports. In addition, for two anticancer drugs for companion dogs (oral melanoma and cutaneous mast cell tumor), the agency conducted an expedited review, thereby moving up the timeline for the introduction of treatments for rare diseases in Korea and providing practical technical support to the veterinary pharmaceutical industry.

Going forward, the Animal and Plant Quarantine Agency plans to continue operating the dedicated new drug review team, while also strengthening its review capacity for high-difficulty new drugs such as advanced biopharmaceuticals and treatments for rare and intractable diseases, for which demand is increasing and whose review standards are relatively more complex and stringent compared to general veterinary drugs. In particular, the agency plans to establish within this year guidelines that systematize tailored safety and efficacy review standards for companion animal pharmaceuticals, thereby solidifying the institutional foundation.

Choi Jeong-rok, head of the Animal and Plant Quarantine Agency, said, "Achieving the performance of approving seven new veterinary drugs in 2025 following 2024 is the result of active communication with the industry through the operation of the dedicated new drug review team," adding, "We will continue to further strengthen tailored technical support for the veterinary pharmaceutical industry, invigorate new drug development, and contribute to improving the health of companion animals."