Full-Scale Efforts Begin to Domesticize Vaccines for Livestock Infectious Diseases Such as Foot-and-Mouth Disease and Lumpy Skin Disease

MAFRA Announces Animal Pharmaceuticals Industry Development Plan
Enacting a Separate Industry Promotion Law for Systematic Support
Introducing Fast-Track Approval to Shorten New Drug Development Period
Aiming to Triple Industry Size and Quintuple Exports by 2035

The government is promoting the localization of vaccines for livestock infectious diseases such as foot-and-mouth disease and Lumpy Skin Disease, which currently rely on imports. In addition, it plans to establish a new Animal Pharmaceuticals Industry Promotion Act to provide systematic support and build a fast-track approval system to accelerate new drug development.

On the 2nd, the Ministry of Agriculture, Food and Rural Affairs (MAFRA) announced the "Animal Pharmaceuticals Industry Development Plan" at the Economic Ministers' Meeting held at the Government Seoul Office.

A MAFRA official explained, "Domestic and international demand for animal pharmaceuticals is expanding, but domestic products are gradually losing their position between the original products from advanced pharmaceutical countries and the low- to mid-priced products from emerging countries such as China, India, and Southeast Asia. Therefore, the government has prepared this new growth strategy to enable the domestic industry to move beyond simple manufacturing growth toward the development of high value-added new products such as new drugs and technology innovation."

First, MAFRA will promote a large-scale research and development (R&D) project to secure core technologies for new drug development and accelerate the cultivation of strategic items. Through this, foot-and-mouth disease and Lumpy Skin Disease vaccines, which are currently fully dependent on imports, will be localized, and development of vaccines for African Swine Fever (ASF), for which no vaccine currently exists, will also be pursued.

Additionally, R&D infrastructure such as the Pohang Public Biofoundry and the Iksan Animal Pharmaceuticals Cluster will be established to support the entire new drug development cycle?including discovery of new drug candidates, clinical and non-clinical trials, and prototype production?for small and medium-sized enterprises, venture companies, and specialized R&D firms. This will help disperse the risks associated with new drug development investments while promoting the securing of core technologies and technology commercialization.

Regulatory approval will be eased. A pre-review system for safety and efficacy data, which often involves many trials and errors and takes a long time during the new drug approval process, will be introduced to support faster market entry of developed products. Furthermore, the function of the currently operating New Drug Review Team (Quarantine Headquarters) will be strengthened to support clinical trial design and establish a fast-track system, aiming to reduce the typical new drug development period of over 7 to 10 years to about 4 to 7 years.

A legal framework for systematic fostering of the animal pharmaceuticals industry will also be established. A MAFRA official said, "Until now, the animal pharmaceuticals industry has been operated only under subordinate enforcement rules of the Pharmaceutical Affairs Act, which limited industrial promotion. We plan to enact a separate industry promotion law to systematically support key elements for strengthening industrial competitiveness, such as research and development and professional workforce training."

Moreover, the government will expand private access to the national Biosafety Level 3 (ABL-3) laboratories necessary for research and development of vaccines against high-risk pathogens such as foot-and-mouth disease, thereby strengthening companies' vaccine development capabilities. The qualification criteria for manufacturing and quality control managers will be relaxed, and the industrial support foundation will be reorganized to reduce management burdens so that companies can actively invest in R&D and technological innovation.

Support for promising export companies will be expanded. The budget for supporting companies in developing export items and obtaining export country approvals?including raw material purchases, clinical trials, product registration, and certification costs?will be continuously increased to strengthen export capabilities. In addition, private capital inflow will be activated through policy financial support and dedicated funds for pet-related industries (10.1 billion KRW) that can invest in animal pharmaceuticals companies, thereby supporting corporate growth.

The advancement of Good Manufacturing Practice (GMP) standards for animal pharmaceuticals, which currently do not meet international standards, will also be promoted. Among the 11 GMP-related items established by the United States and the European Union (EU), Korea has institutionalized only three. However, to alleviate companies' burdens such as facility and equipment investments associated with GMP advancement, a five-year preparation period will be taken, including establishing the institutional foundation (2025?2026) and re-evaluating compliance with current GMP (2027?2029). From 2030 to 2035, the necessary GMP advancement items will be introduced step-by-step according to their difficulty.

MAFRA aims to triple the industry scale from 1.3 trillion KRW in 2023 to 4 trillion KRW by 2035 and expand export volume to 1.5 trillion KRW, five times the 2023 level, by faithfully implementing this plan.

Song Mi-ryeong, Minister of Agriculture, Food and Rural Affairs, said, "Through this industry development plan, we will significantly grow the animal pharmaceuticals industry in the mid to long term and foster it as a new growth industry that drives the national economy through the development of high value-added new products and technological innovation."