'Introduction of Animal Vaccine Seed Lot System' Basic Plan Established
Pilot Introduction in 2025 Followed by Gradual Implementation from 2026 to 2032
The government has decided to establish a system that verifies quality from the stage of microorganisms used in vaccine manufacturing to improve the quality of animal vaccines and enhance international competitiveness.
The Animal and Plant Quarantine Agency under the Ministry of Agriculture, Food and Rural Affairs announced on the 2nd that it plans to introduce the 'Seed Lot System (SLS)' based on this content.
An official from the Quarantine Agency explained, "Currently, animal vaccines are approved by evaluating the safety and efficacy of finished pharmaceuticals. By introducing SLS, a system will be established to verify quality from the 'master seed' stage, such as microbial strains or cells used in vaccine manufacturing."
This system is already in operation in the United States, Europe, and Japan. The government expects that by confirming genetic stability and the presence of foreign microbial contamination in the master seed at the product approval stage, the reliability of the entire vaccine manufacturing process can be enhanced.
Accordingly, since 2021, the Quarantine Agency has continuously consulted with domestic animal vaccine manufacturers and importers to minimize the impact on domestic manufacturing sites and has established a basic plan to apply SLS not only to newly approved products but also to previously approved products.
At the core of the SLS system, the review of vaccine 'seed lot' quality management will be strengthened at the product approval stage, with a phased introduction differentiating between new and existing approved products. From 2025, a one-year pilot application will target only inactivated (non-toxic and non-infectious) single bacterial formulations, followed by full expansion to all formulations from 2026. For existing products, some test items per formulation will be allowed to be omitted, with gradual introduction over up to seven years from 2026 to 2032. For national inspection tests, vaccines approved under SLS will have some test items omitted for simplification, while other vaccines will maintain the current national inspection standards, operating a dual system.
Goo Hyun-ok, Director of the Animal Drug Evaluation Division at the Quarantine Agency, said, "With the introduction of SLS, higher quality animal vaccines will be supplied to consumers including livestock farmers, and trust in overseas markets will increase, enhancing export competitiveness. We will actively communicate with related industries and seek multifaceted support measures to ensure the new system is quickly established."
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