South Korea tightens veterinary medicine standards to align with global GMP norms

The South Korean government is implementing phased reforms to enhance the quality, safety, and export potential of veterinary medicines, bringing regulations closer to international good manufacturing practice standards by 2035.

South Korea has moved to tighten standards for veterinary medicines, with the agriculture ministry revising rules to bring manufacturing and quality control closer to international good manufacturing practice norms.

According to the Ministry of Agriculture, Food and Rural Affairs, the overhaul is intended to strengthen product quality and safety while improving the export prospects of domestic animal drug makers. The ministry said the new framework reflects a global trend towards stricter validation of production processes, facilities and equipment.

The changes will be phased in between 2030 and 2035, beginning with injectables, after allowing industry time to adjust facilities and procedures. From 2027, the government will also split regulation into six product categories, replacing the current two-tier system that broadly distinguished between standard veterinary medicines and biologicals such as vaccines.

The revised regime will move away from factory-level oversight towards product-specific controls within the same plant, and it will introduce a three-year renewal review from 2027 to check whether manufacturing sites continue to meet GMP standards.

The ministry said the aim is to build a system aligned with global practice. The World Health Organisation, the US Food and Drug Administration and the European Medicines Agency all describe GMP as a baseline for consistent production, quality control and market confidence in medicines, including veterinary products.