The government will introduce a fast track for new animal pharmaceuticals and accelerate large-scale research and development projects. The goal is to enhance the innovation capacity of the industry in response to deepening global competition and to expand the export scale to five times the current level by 2035.
The Ministry of Agriculture, Food and Rural Affairs reported on the 'Animal Pharmaceuticals Industry Development Plan' at the economic relations ministers' meeting chaired by Deputy Prime Minister and Minister of Economy and Finance Choi Sang-mok on the 2nd.
The government plans to expand the domestic animal pharmaceuticals market from the current 1.3 trillion won to 4 trillion won by 2035, with exports increasing from 300 billion won to 1.5 trillion won. To achieve this, it will promote systemic improvements and regulatory refinements across the industry.
First, a 'fast track' system will be introduced to shorten the development period for new animal drugs. Starting in 2026, a consulting system will operate with pre-review and clinical trial design support, reducing the development time from the existing 7-10 years to 4-7 years. Conditional approvals will be applied to treatments for rare diseases or products utilizing foreign clinical data, thereby streamlining the approval process.
A large-scale national research and development project for new drug development will also be initiated. The government is preparing a preliminary feasibility study for 2026 and will concentrate support for research and development on strategic items, starting with technologies to respond to national disaster diseases like foot-and-mouth disease and African swine fever (ASF), and advancing to cutting-edge animal medicines like gene therapies. For this purpose, a biofoundry is being established in Pohang, North Gyeongsang Province, and a new drug development cluster is being built in Iksan, North Jeolla Province.
A legal foundation will also be established. Through the 'Animal Pharmaceuticals Industry Support Act' proposed last July, the government aims to systematize the establishment of a long-term comprehensive plan as well as support for research and development, exports, and personnel. The Animal Quarantine Agency will also open its biosafety facilities to the private sector, strengthening the base for high-risk vaccine development.
The quality control system will also be revised. The government plans to fully implement the Good Manufacturing Practices (GMP) for animal drugs by 2035, as currently only three out of 11 core items are applied. A seed-lot system will be implemented starting this year to ensure vaccine quality. Additionally, a system for renewing product approvals and conducting local inspections of imported pharmaceuticals will also be promoted.
Support for expanding exports will also increase. From next year, the government plans to strengthen budget support for clinical trials and overseas registration expenses, as well as expand loans and policy fund investments for exporting corporations. Training of specialized personnel in testing, quality, and approval fields will be pursued at a scale of 300 people per year.
In addition, the government will systematize licensing criteria information by country and develop customized strategies for major export countries to support overseas expansion. In particular, it plans to strengthen certification support and local marketing focused on the Southeast Asia and Latin America regions, which have high growth potential.