The South Korean government is set to adjust the production and quality management standards for animal drugs to align with international levels. This move aims to enhance the export competitiveness of domestically produced animal pharmaceuticals.
The Ministry of Agriculture, Food and Rural Affairs announced on July 30 that it has revised and published the 'Regulations on the Handling of Animal Drugs.'
First, the Good Manufacturing Practice (GMP) standards will be strengthened to meet international benchmarks. In response to the recent trend of tightening manufacturing process and facility verification standards in the global animal pharmaceutical sector, domestic standards will also be updated. To allow the industry time to prepare, the new GMP standards will be phased in from 2030 to 2035, categorized by formulation types.
Additionally, a tailored management system will be established based on product characteristics. Previously, the classification was limited to two categories: general pharmaceuticals and vaccines. This will be expanded to six categories, including raw materials, starting next year. Furthermore, within the same manufacturing facility, processes and quality management will be adapted to suit the specific characteristics of the products. Facilities that have already received GMP compliance certification will be exempt from submitting documentation when applying for product approval for the same formulation.
A renewal system will also be introduced to strengthen post-market surveillance. Starting next year, facilities will undergo regular checks every three years to ensure compliance with GMP standards.
A ministry official stated, "We expect that the advancement of GMP standards will enhance the global credibility of the domestic animal pharmaceutical industry and serve as a foundation for boosting export competitiveness."
The Ministry of Agriculture, Food and Rural Affairs announced on July 30 that it has revised and published the 'Regulations on the Handling of Animal Drugs.'
First, the Good Manufacturing Practice (GMP) standards will be strengthened to meet international benchmarks. In response to the recent trend of tightening manufacturing process and facility verification standards in the global animal pharmaceutical sector, domestic standards will also be updated. To allow the industry time to prepare, the new GMP standards will be phased in from 2030 to 2035, categorized by formulation types.
Additionally, a tailored management system will be established based on product characteristics. Previously, the classification was limited to two categories: general pharmaceuticals and vaccines. This will be expanded to six categories, including raw materials, starting next year. Furthermore, within the same manufacturing facility, processes and quality management will be adapted to suit the specific characteristics of the products. Facilities that have already received GMP compliance certification will be exempt from submitting documentation when applying for product approval for the same formulation.
A renewal system will also be introduced to strengthen post-market surveillance. Starting next year, facilities will undergo regular checks every three years to ensure compliance with GMP standards.
A ministry official stated, "We expect that the advancement of GMP standards will enhance the global credibility of the domestic animal pharmaceutical industry and serve as a foundation for boosting export competitiveness."
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.