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    12. Resources (listed in descending order of precedence)
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    12. Resources (listed in descending order of precedence)

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    Article summary

    1. Ministry of Food and Drug Safety (MFDS) Our Works, MFDS, accessed December 2022
    2. Global Regulatory Partners Inc (February 2022) Clinical Trial Application (CTA) in South Korea, Global Regulatory Partners, accessed December 2022
    3. Bioethics and Safety Act 2008 
    4. Ho-Dong L, Soon-Young S and Cha-Won K (2020) ‘Registration status of Institutional Review Boards (IRBs) and Changes to Responsible Organizations in Korea’, CDC, accessed December 2022
    5. Korea Customs Service (KCS) Information Plaza, KCS, accessed December 2022
    6. Ministry of Food and Drug Safety (MFDS) (2018) Guideline on Quality Assessment for Gene-Editing Based Advanced Therapy Medicinal Products [for industry], MFDS, accessed December 2022
    7. Korean Food and Drug Administration (FDA) (2000), Guideline for Korean Good Clinical Practice, FDA, accessed December 2022
    8. Credevo (Feasibility Team) (2021) South Korea – Clinical Trials Regulatory Process, Credevo, accessed December 2022
    9. Clinical Research Information Service (CRIS) (n.d.) CRIS Registration Status, Korean Disease Control and Prevention Agency (KDCA), accessed December 2022
    10. Korean Institute of Drug Safety and Risk Management (KIDS) (n.d.) Introduction of KAERS, KIDS, accessed December 2022
    11. 3H Medi Solution (2021) Home Based Clinical Trials in South Korea and 3H Initiative, 3H, accessed December 2022
    12. Digital Signature Act 2020
    13. Personal Information Protection Act (2011)
    14. Ministry of Food and Drug Safety (MFDS) (2022) Regulation on the Labelling of Medicinal Products etc., MFDS, accessed December 2022
    15. Ministry of Food and Drug Safety (MFDS) (1998) Guidelines for Recommending Drugs and Cosmetics for Exemption from Import Requirements, MFDS, accessed December 2022
    16. M&B (3 November 2021) Importing Goods into South Korea, M&B, accessed December 2022
    17. Be loved JR (12 August 2016) Import License – Country specific requirements, blog, accessed December 2022
    18. Korea Customs Service (KCS) Export Declaration Guideline, KCS, accessed December 2022
    19. DocuSign (n.d.) eSignature Legality in South Korea, DocuSign, accessed December 2022
    20. Hyun-tai S (7 August 2021) ‘Decentralized clinical trials need deregulation, detailed guidelines’, Korea Biomedical Review, accessed December 2022
    21. Roh J (22 March 2022) ‘Telemedicine booms in S.Korea amid COVID, President-elect Yoon back practice’, Reuters, accessed December 2022
    22. Personal Information Protection Act (General Law) (2020)
    23. Act on Promotion of Information and Communications Network Utilization and Information Protection (2016)
    24. Paulger D (June 2022) ‘South Korea Status of Consent for Processing Personal Data’ Asian Business Law Institute, accessed December 2022
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