SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
request if it falls into one of the following cat- egories: (i) a drug used for treating serious or rare diseases with no alternative available, or one expected to significantly improve safety and efficacy compared to existing alternatives; and (ii) a new drug developed by an innovative pharmaceutical company designated as such by the MHW. Such designated drugs must be reviewed within 90 days, barring exceptional circumstances. According to the Act on the Safety and Sup- port for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, drugs can be designated for expedited processing upon the request of the developer if any of the following conditions is met: (i) for the treatment of life- threatening diseases like cancer with no alter- natives; (ii) for the treatment of rare diseases as defined by the Rare Diseases Management Act; or (iii) for the prevention or treatment of bioter- rorism-related or other pandemic infectious dis- eases. These expedited drugs will be prioritised over other non-designated product approvals. The Special Act on the Promotion of Develop- ment and Emergency Supply of Medical Prod- ucts for Public Health Crisis Response man- dates that preliminary crisis-response medical products, designated by the head of MFDS for preventing or treating infectious diseases pos- ing a serious threat to public health, should be reviewed within 40 days barring exceptional cir- cumstances. For medical devices, an expedited review sys- tem exists for orphan medical devices, inno- vative medical devices, and those under the integrated review of approval and new medical technology assessment. The MDA stipulates that orphan medical devices, designated by the head of MFDS for their special utility value for
rare diseases, can be reviewed and approved expeditiously. The Medical Device Industry Enhancement and Innovative Medical Device Support Act allows for advanced technological devices, significantly improving upon existing devices or treatments, to also receive expedited review. Regulations for the Integrated Operation of Medical Device Approvals and Assessments aim to shorten the market entry period by con- currently reviewing device approval, insurance benefit eligibility, and new medical technology assessments. 4.2 Regulatory Reliance South Korea does not have a system in place for the expedited approval of pharmaceuticals that have been approved in other countries. However, there are regulations that allow for the submission of clinical trial data conducted abroad when applying for market approval (or notification, as applicable) of pharmaceuticals. According to the PAA, foreign clinical trial data can be submitted in place of safety and efficacy data for Koreans during the domestic approval process. However, due to ethnic differences, it is challenging to only use foreign clinical data. Therefore, the law requires that simplified clini- cal trial data obtained from studies conducted specifically on Koreans be submitted together with the foreign clinical data. Regarding medical devices, the MDA stipulates that clinical trial data related to the safety and efficacy of the medical devices must be sub- mitted during the approval process. Submis- sion of foreign data generated by institutions recognised for their reliability and determined to have been generated in accordance with medi- cal device clinical trial management standards is allowed. While submission of bridging data is not explicitly mandatory for medical devices, the
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