Risk assessment of living modified organisms for healthcare purposes

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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).

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Risk assessment procedure for living modified organisms for healthcare use

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[보건의료용 LMO 위해성심사 절차]

Documents to be submitted for risk assessment of living modified organisms for healthcare use

  • 위해성심사제출자료
    1. Application form for risk assessment of living modified organisms
    2. Submission table for risk assessment data
    3. Risk assessment data for living modified organisms
    4. Korean summary of the risk assessment report
    5. Supporting documents for submitted materials (references, standards, etc.)
    6. Government import approval - Issuance for administrative fees (4 million KRW)
    The relevant form is attached in the Library [View form].
    - Safety management guide for living modified organisms

The risk assessment data submitted when applying for risk assessment of LMOs for healthcare use must meet the requirements specified in Article 5-2 of the “Consolidated Notice on the Transboundary Movements, etc. of Living Modified Organisms.

  1. Data published in professional journals
  2. Data tested according to Good Laboratory Practice (GLP) standards
  3. 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
  4. 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 procedure for risk assessment of LMOs for healthcare use

  • 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
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