Risk assessment of living modified organisms for healthcare purposes

Risk assessment for the use of healthcare-related living modified organisms

Entities who wish to import, produce, or utilize LMOs for health and medical purposes must undergo a risk assessment by the Korea Disease Control Agency in accordance with Article 7-2 (1) of the Act on Transboundary Movements, etc. of Living Modified Organisms.
- The risk assessment of living modified organisms is evaluated through a comparative analysis with existing species (non-living modified host organisms).

유전자변형생물체 위해성 평가 다이어그램. 인체 위해성과 환경 위해성으로 구분하여 분석.

보건의료용 유전자변형생물체 위해성 심사 절차 흐름도. 신청부터 자료 제출·검토·심사 및 결과 통보까지 단계별로 구성됨.

[보건의료용 LMO 위해성심사 절차]

Data published in professional journals
Data tested according to Good Laboratory Practice (GLP) standards
Data tested at domestic and international specialized institutions such as universities or research organizations, issued by the head of the institution, and reviewed to be deemed valid, which must include an overview of the research facility, major equipment, composition of research personnel, and the research experience of the testers
Data submitted during the risk assessment of living modified organisms in foreign countries; documents must confirm that the foreign government has approved the use of living modified organisms

Application documents: Submit the application documents along with the application for risk assessment of living modified organisms.
How to submit: Submit one printed copy and 12 electronic copies of the documents either by electronic mail or by post. If submitting by email, the original must be sent by mail.
Where to submit: Biological Safety Assessment Division, Centers for Disease Control and Prevention
Processing period (If there is a document supplementation period, the supplementation period is not included in the processing deadline.)
- Notification of results: Within 270 days