1. Reasons for Revision
a. Establishing manufacturing, safety management, and evaluation standards for handling high-risk pathogens to lay the foundation for domestic production of vaccines against national disaster-type animal infectious diseases.
b. Supporting the activation of genetic engineering-based animal pharmaceutical industries by establishing safety management systems for handling genetically modified organisms (GMOs) used in animal medicines.

2. Key Content

a. Establishing standards for handling and safety management of genetically modified organisms (Article 4-2, Table 6)

• Manufacturers handling genetically modified organisms must comply with storage, transportation management, and emergency response standards.

b. Addition of necessary facilities and equipment for the manufacturing and testing of biological products (Table 3)

• To ensure safety when handling animal infectious disease pathogens, additional facilities such as biosafety workstations and equipment to prevent emergency incidents like pathogen leaks are required.

c. Establishment of facilities and equipment for high-risk pathogen handling workplaces (Table 5)

• Locking devices at main entrances, security systems, and biosafety signage.

• Air conditioning systems to minimize cross-contamination between pathogen-exposed areas and other manufacturing zones.

• Supporting facilities such as pipelines, electricity, gas, pathogen handling support systems, hand sanitizers, eye wash stations, and emergency shower facilities.

d. Establishment of manufacturing and quality management evaluation standards for biological product workplaces, high-risk pathogen handling workplaces, and safety management of genetically modified organisms (Table 7)

• Backflow prevention devices for aseptic workstations, air conditioning systems to maintain negative pressure in pathogen-exposed areas, documentation of emergency response management systems in case of biosafety incidents, and more.