[Experimental Guidelines for Genetic Modification (2025 Revision): Understanding Biological Risk Group...

This document introduces the Experimental Guidelines for Genetic Modification, including recent revisions (Ministry of Health and Welfare Notice No. 2025-152), which serve as a biosafety reference for biotechnology research and development institutions and provide information on listed biological agents classified by risk group.

Biological agent classification by risk group is based on international references, including U.S. National Institutes of Health Guidelines, the UK Approved List of Biological Agents, and domestic references including the Pathogen Biosafety Data Sheet published by the Korea Disease Control and Prevention Agency (KDCA). Viral taxonomy and nomenclature meeting the new naming rules of the International Committee on Taxonomy of Viruses (ICTV) have also been reviewed. Guideline revisions were prepared through consultation with academic, research, and industrial institutions and reviewed by the KDCA's Health and Biosafety Expert Committee.

Biological agent risk group classification, spanning Risk Groups 1 through 4, has remained unchanged since the most recent revision (2022). However, the guidelines have been updated to reflect ICTV-recommended virus nomenclature changes, with revised and existing virus names presented in parallel.

This revision updates the classification and nomenclature of biological agents to align with current international standards. The KDCA will continue to improve and advance its Experimental Guidelines for Genetic Modification to ensure that biosafety assessments and management systems in bioscience research institutions operate in compliance with global biosafety standards.