台灣臨床試驗環境之改善策略：以韓國臨床試驗產業為鑒

Abstract

全球醫藥市場在慢性病藥物需求增加和COVID-19疫情影響下快速增長。臨床試驗是評估藥品對人體療效與安全性的必要環節，在新藥、學名藥及生物相似藥的研發與生技醫藥產業的發展中扮演關鍵角色。台灣與韓國具有相似的歷史背景和社會經濟環境，但臨床試驗環境卻存在著顯著差異。現今，韓國已然成為亞太地區臨床試驗的領頭羊，其臨床試驗環境在全球臨床試驗產業具有強大的競爭力，吸引國際生技醫藥業者投入其中。 本研究旨在深入探討韓國臨床試驗環境吸引國際生技醫藥業者的關鍵因素，並從中汲取經驗，提出改善台灣臨床試驗環境的具體策略。透過文獻分析法，廣泛蒐集與台灣和韓國臨床試驗法規條例、醫藥產業政策、醫療資源以及受試者招募等相關資訊，系統性地比較兩國臨床試驗環境的差異。 研究結果顯示，韓國政府自1990年代後半起積極制定並不斷完善臨床試驗相關法規，建立了有效的臨床試驗管理系統，並設立了多個專業機構來推動臨床試驗產業發展。韓國在法規完善性、主管機關支持、受試者招募速度和試驗啟動效率上均具有明顯優勢。 根據韓國的成功經驗，本研究提出改善台灣臨床試驗環境的具體建議，包括：強化法規管理，加速審查流程，提升受試者招募效率，增加臨床試驗資源投入，並建立有效的臨床試驗數據管理系統。透過這些措施，期望能提升台灣在全球臨床試驗市場中的競爭力，吸引更多國際生技醫藥業者來台進行臨床試驗，進一步促進台灣生技醫藥產業的發展與國際接軌。

The global pharmaceutical market has been rapidly expanding due to the increased demand for chronic disease medications and the impact of the COVID-19 pandemic. Clinical trials are essential for evaluating the efficacy and safety of drugs on humans, playing a crucial role in the development of new drugs, generics, and biosimilars, as well as the growth of the biotech and pharmaceutical industries. Taiwan and South Korea share similar historical backgrounds and socio-economic environments, yet their clinical trial environments differ significantly. South Korea has emerged as a leader in the Asia-Pacific region's clinical trial industry, demonstrating strong competitiveness in the global clinical trial sector and attracting international biotech and pharmaceutical companies. This study aims to delve into the key factors that make South Korea's clinical trial environment attractive to international biotech and pharmaceutical companies. By drawing lessons from South Korea's experience, this study proposes specific strategies to improve Taiwan's clinical trial environment. Through literature analysis, the study extensively collects information related to the clinical trial regulations, pharmaceutical industry policies, medical resources, and participant recruitment in Taiwan and South Korea, systematically comparing the differences between the two countries' clinical trial environments. The research findings indicate that since the late of 1990s, the South Korean government has been actively developing and continuously improving clinical trial-related regulations, establishing an effective clinical trial management system, and setting up several specialized institutions to promote the development of clinical trial industry. South Korea excels in regulatory comprehensiveness, governmental support, participant recruitment speed, and trial initiation efficiency. Based on South Korea's successful experience, this study proposes several recommendations to enhance Taiwan's clinical trial environment, including strengthening regulatory management, accelerating the review process, improving participant recruitment efficiency, increasing investment in clinical trial resources, and establishing an effective clinical trial data management system. By implementing these measures, it is hoped that Taiwan's competitiveness in the global clinical trial market will be enhanced, attracting more international biotech and pharmaceutical companies to conduct clinical trials in Taiwan, thereby further promoting the development and international integration of Taiwan's biotech and pharmaceutical industry.