FROMANNUAL REVIEWS

2025 AOAC INTERNATIONAL Annual Meeting & Exposition

•

August 26, 2025

•

San Diego, United States

South Korea’s National Post-Market Surveillance (NPMS) program annually collects and tests approximately 1,650 marketed veterinary chemical drugs under formulation- and ingredient-based plans. Eighteen public authorities including 17 provincial governments and the Animal and Plant Quarantine Agency (APQA) collect products, while a testing laboratory designated by APQA has performed all active ingredient assays since 2018. The Efficacy & Adverse-Effect Monitoring (EAEM) program complements NPMS by retesting manufacturer-retained products from NPMS noncompliants and investigating complaints submitted through public portals and repeat-offender targeting. Though separately operated, the two systems are linked by a risk-tiered feedback mechanism. From 2018 to 2024, NPMS tested 11,579 products, detecting 193 non-compliances (1.7%), mainly powders (42%) and injectables (31%). Frequent noncompliances involved vitamin A, dexamethasone, spiramycin, amoxicillin, colistin, and florfenicol. Retained-product retesting confirmed 87 noncompliants (58.8%), but the system was abolished in 2024 due to growing concerns over the reliability of equivalence between retained and marketed products in some manufacturers. In 2024, following the phase-out of retained-collected product testing, additional tests focusing on formulation-specific quality features such as sterility, pH, and disintegration were conducted. EAEM also performs regular tasks such as contract lab proficiency testing, LC-MS/MS cross-contamination screening, bioequivalence trials, disinfectant efficacy evaluation (ASF, AI, FMD), and veterinary diagnostic kit performance tests. Through structured NPMS sampling, EAEM verification, and targeted pharmacovigilance inspections, Korea has maintained a noncompliance rate below 2% for veterinary chemical drugs, and uses NPMS and EAEM data to guide GMP oversight and improve regulatory policy.

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