SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Eunkyoung Lyu and Soo Yeon Park, Lee & Ko
falls into one of the following categories: (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 MOHW. Such designated drugs must be reviewed within 90 days, barring exceptional circum- stances. According to the Act on the Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals, drugs can be designated for expedited processing upon the request of the devel- oper if any of the following conditions are met: (i) for the treatment of life-threatening diseases like cancer with no alternatives; (ii) for the treatment of rare dis- eases as defined by the Rare Diseases Management Act; or (iii) for the prevention or treatment of bioter- rorism-related or other pandemic infectious diseases. These expedited drugs will be prioritised over other non-designated product approvals. The Special Act on the Promotion of Development and Emergency Supply of Medical Products for Pub- lic Health Crisis Response mandates that preliminary crisis-response medical products, designated by the head of MFDS for preventing or treating infectious dis- eases posing a serious threat to public health, should be reviewed within 40 days barring exceptional cir- cumstances. For medical devices, an expedited review system exists for orphan medical devices, innovative medi- cal devices, and those under the integrated review of approval and new medical technology assessment. The MDA stipulates that orphan medical devices, des- ignated by the head of MFDS for their special utility value for rare diseases, can be reviewed and approved expeditiously. The Medical Device Industry Enhance- ment and Innovative Medical Device Support Act also allows for advanced technological devices which significantly improve upon existing devices or treat- ments, to receive expedited review. Regulations for the Integrated Operation of Medical Device Approv- als and Assessments aim to shorten the market entry period by concurrently reviewing device approval,
insurance benefit eligibility, and new medical technol- ogy 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 mar- keting authorisation (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. How- ever, due to ethnic differences, it is challenging to only use foreign clinical data. Therefore, the law requires that simplified clinical trial data obtained from stud- ies 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 submitted during the approval process. Submission of foreign data gen- erated by institutions recognised for their reliability and determined to have been generated in accord- ance with medical device clinical trial management standards is allowed. While submission of bridging data is not explicitly mandatory for medical devices, the MFDS may request additional data from domestic trials if it is deemed difficult to directly apply foreign clinical trial data. 5. Manufacturing of Pharmaceuticals and Medical Devices 5.1 Requirement for Authorisation for Manufacturing Plants A manufacturing plant of pharmaceutical products is subject to an authorisation for manufacturing pharma- ceuticals under the PAA, while a manufacturing plant of medical devices requires an authorisation under the MDA. Such authorisations are granted by the MFDS. An applicant intending to manufacture pharmaceu- ticals or medical devices, must prepare and file the application for manufacturing authorisation and nec-
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