Safety management of high-risk pathogens (Article 23 of the Infectious Disease Control and Prevention Act and Article 19-6 of the Enforcement Decree of the same Act)
- A person who intends to examine, possess, control, or transfer high-risk pathogens shall establish and operate facilities necessary for the examination, possession, control, and transfer thereof (hereinafter referred to as the "facilities handling high-risk pathogens"), or enter into a contract for the use of the facilities handling high-risk pathogens with a person who establishes and operates the facility handling high-risk pathogens.
- A person who intends to establish and operate facilities handling high-risk pathogens shall obtain permission from the Commissioner of the Korea Disease Control and Prevention Agency or file a report thereon with the Commissioner of the Korea Disease Control and Prevention Agency according to the safety control level of the facilities handling high-risk pathogens. In such cases, if there are two or more persons who intend to establish and operate the facilities handling high-risk pathogens, they shall obtain permission or file a report jointly.
- Where a person who has obtained permission pursuant to paragraph (2) intends to modify any of the matters permitted, he or she shall obtain permission for such modification.
Compliance requirements for high-risk pathogen safety management
- There shall be a person in charge of the installation and operation of high-risk pathogen handling facilities, a dedicated manager for high-risk pathogens, and a bio-safety management officer.
- An advisory body composed of external experts and bio-safety management officers shall be established and operated in the high-risk pathogen handling facilities to review matters related to the safety management of inspection, possession, management, and transportation of high-risk pathogens.
- High-risk pathogens must be preserved in storage units that display relevant information such as the name of the high-risk pathogen, management number, identification number, and date of manufacture, and these units must be kept in a separate storage box or equipment with a security locking device.
- Access to the handling area and storage area of high-risk pathogens shall be restricted, and a security system capable of verifying the handling of high-risk pathogens must be operated
- If it is intended to inactivate high-risk pathogens (processing them in such a way that they cannot survive permanently without disposal), it must undergo a review by the advisory body as specified in item 2.
Head of the high-risk pathogen handling institution
Institution Biosafety Committee
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Medical Administrator
※ Possible to connect with external medical institutions.
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Biosafety Management OfficerDedicated manager for high-risk pathogens
※ The Biosafety Management Officer can serve concurrently.
Biosafety Manager (if designated)
Practical Manager (if designated)