SOUTH KOREA Law and Practice Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
1. Life Sciences Regulatory Framework 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices The primary legislation governing pharmaceu- ticals in Korea is the Pharmaceutical Affairs Act (PAA). The Act on the Safety of and Sup- port for Advanced Regenerative Medicine and Advanced Biological Products (AABP) regulates cutting-edge biopharmaceutical products such as cell therapy, gene therapy, and tissue engi- neered products. The Medical Devices Act and the In-Vitro Medical Devices Act (collectively, MDA) regulate medical devices. All Acts, togeth- er 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 prod- ucts, including 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 guide- lines. The Digital Medical Product Act will now have precedence over those regulations. It will first be effective for digital medical devices and digital integrated drugs on 24 January 2025, and sequentially for digital medical/healthcare sup- port devices on 24 January 2026. The Ministry of Health and Welfare (MHW) and the MFDS (which is overseen by the MHW) are the main regulatory bodies in relation to phar- maceuticals and medical devices, and they are responsible for issuing and enforcing most of the regulations, guidelines and administrative orders
for pharmaceuticals and medical devices. Local governments (such as the Seoul Metropolitan government) also monitor pharmaceutical and medical device entities within their jurisdiction. 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation Administrative orders issued by the MFDS, MHW or local governments to entities in violation of the PAA, AABP or MDA may be challenged via an administrative appeal to the competent admin- istrative appeals commission under the Adminis- trative 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 commission or court revoke or declare null the administrative order. Rulings rendered by an administrative appeals commission may also be appealed to the com- petent court. In general, these challenge procedures are appli- cable to other regulated products, such as food products. 1.3 Different Categories of Pharmaceuticals and Medical Devices Pharmaceuticals are categorised into over-the- counter (OTC) drugs and prescription drugs. In principle, all pharmaceuticals must be delivered to patients by licensed pharmacists at pharma- cies, except in some cases such as administra- tion of pharmaceuticals to patients by doctors within medical institutions. While prescription drugs require a prescription from physicians, OTC drugs can be supplied to consumers with- out a prescription. Additionally, the MHW has designated certain OTC drugs as emergency drugs to treat light symptoms in urgent situations at patients’ discretion, and such OTC drugs may be sold at 24-hour convenience stores by non-
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