SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Eunkyoung Lyu and Soo Yeon Park, Lee & Ko
Lee & Ko Hanjin Building 63 Namdaemun-ro Jung-gu Seoul 04532 South Korea Tel: +82 2 772 3036 Fax: +82 2 772 4001/2 Email: keumnang.park@leeko.com Web: www.leeko.com
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation The primary legislation governing pharmaceuticals in Korea is the Pharmaceutical Affairs Act (PAA). The Act on the Safety of and Support for Advanced Regen- erative Medicine and Advanced Biological Products (AABP) regulates cutting-edge biopharmaceutical products such as cell therapy, gene therapy, and tis- sue engineered products. The Medical Devices Act and the In-Vitro Medical Devices Act (collectively, MDA) regulate medical devices. All Acts, together with related presidential decrees, regulations and guidelines, are promulgated by the Office of the Prime Minister and the Ministry of Food and Drug Safety (MFDS). On a related note, the Digital Medical Product Act was newly enacted on 23 January 2024. It aims to define and regulate digital medical products, includ- ing digital medical devices, digital integrated drugs, and digital medical/healthcare support devices. Such products were previously governed by the existing PAA, Medical Device Act, In Vitro Diagnostic Medical Devices Act, their subordinate regulations, and MFDS guidelines. The Digital Medical Product Act will now have precedence over those regulations. It will first be effective for digital medical devices and digital inte- grated drugs on 24 January 2025, and sequentially for digital medical/healthcare support devices on 24 January 2026. The Ministry of Health and Welfare (MOHW) and the MFDS (which is overseen by the MOHW) are the main
regulatory bodies in relation to pharmaceuticals and medical devices, and they are responsible for issuing and enforcing most of the regulations, guidelines and administrative orders for pharmaceuticals and medi- cal devices. Local governments (such as the Seoul Metropolitan government) also monitor pharmaceuti- cal and medical device entities within their jurisdiction. 1.2 Challenging Decisions of Regulatory Bodies Administrative orders issued by the MFDS, the MOHW or local governments to entities in violation of the PAA, AABP or MDA may be challenged via an administra- tive appeal to the competent administrative appeals commission under the Administrative Appeals Act, or via administrative litigation to the competent court under the Administrative Litigation Act. In most cases, either action will request that the competent commis- sion or court revoke or declare null the administrative order. Rulings rendered by an administrative appeals commission may also be appealed to the competent court. In general, these challenge procedures are applicable to other regulated products, such as food products. 1.3 Categories of Pharmaceuticals and Medical Devices Pharmaceuticals are categorised into over-the-coun- ter (OTC) drugs and prescription drugs. In principle, all pharmaceuticals must be delivered to patients by licensed pharmacists at pharmacies, except in some cases such as administration of pharmaceuticals to patients by doctors within medical institutions. While
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