South Korea to raise veterinary drug GMP standards to international level, require triennial reviews

South Korea will tighten its good manufacturing practice standards for veterinary drugs to bring them in line with international norms, subdividing requirements by product type and mandating reassessment of manufacturing facilities every three years.

The Ministry of Agriculture, Food and Rural Affairs said Thursday it had revised and promulgated the Rules on Handling of Veterinary Drugs to raise the quality and safety of veterinary pharmaceuticals and strengthen their export competitiveness.

GMP refers to the standards governing manufacturing facilities, processes and quality-control procedures to ensure veterinary drugs are produced safely and at consistent quality.

The revised rules will first raise verification standards for manufacturing processes, facilities and equipment to international levels. To give the industry time to upgrade its facilities, veterinary drugs will be divided into three dosage-form groups, with the stricter standards applied sequentially starting with injectables.

Group 1 covers injectables and infusions; Group 2 covers external-use and oral liquid preparations; and Group 3 covers biological products and active pharmaceutical ingredients. The enhanced standards will be phased in between 2030 and 2035.

Product-specific GMP standards will also be introduced. Under the current system, veterinary drugs are classified into two categories — general veterinary drugs and biological products such as vaccines. The new framework expands this to six categories: finished products, active pharmaceutical ingredients, biological products, radiopharmaceuticals, medical high-pressure gases and blood products. The new standards take effect in 2027.

The management approach will also shift from a facility-centered model to a product-centered one, restructuring the system so that manufacturing processes and quality controls are tailored to the characteristics of each product even when produced at the same facility.

The revision also reduces some administrative burden on companies. Manufacturers whose facilities have already received GMP approval will be exempt from submitting GMP-related documents when applying for product approval for the same dosage form, except in the case of new drugs and biological products.

A renewal regime to strengthen post-approval oversight will also be introduced in 2027. Previously, a facility needed only a single approval at the time of initial licensing; going forward, it will be required to undergo reassessment every three years.

The ministry said it expects the overhaul to establish a manufacturing and quality-control system that meets international standards, boosting the credibility and export competitiveness of South Korea's veterinary pharmaceutical industry. It added that it will continue consultations with relevant industry associations and companies to help the new system take root.