臺灣、中國、美國、澳洲健康食品監管體制之研究

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题名:	臺灣、中國、美國、澳洲健康食品監管體制之研究 The regulatory affairs study on Health Food of Taiwan, China, USA and Australia
作者:	劉欣維;Sin-Wei Liu
贡献者:	製藥碩士學位學程
关键词:	健康食品;保健食品;膳食補充品;補充藥品;特殊目的食品;Health Foods;Dietary Supplements;Complementary supplements;Special Purpose Foods
日期:	2018-06-13
上传时间:	2018-12-25 10:15:40 (UTC+8)
出版者:	中國醫藥大學
摘要:	隨著經濟成長，國人總體生活水準提升，民眾對於健康養生的意識也逐漸提高。在華人自古存在的藥膳養生觀推波助瀾下，台灣保健食品的興盛有目共睹。然而，自台灣健康食品標章開辦至今已近20年，註冊品項卻僅有四百餘種。本研究透過研讀健康食品與相關產品的法規與主管機關的管理方式，第一章探討我國健康食品制度可能未被滿足的原因。第二章至第五章介紹台灣、中國、美國和澳大利亞的健康食品及相關產品監督管理制度。每章從各國健康食品的發展現況出發，探討主管機關的行政管理。著重於闡述查驗登記的申請流程與功效驗證的科學方法與產品廣告標示。第六章通過健康食品及其相關產品的審批程序、健康宣明和廣告標示比較台灣、中國、美國和澳大利亞的不同之處與台灣健康產業與法律體制的競爭態勢分析。台灣健康產業的優勢與劣勢，從產業面而言，注重學術與品質的特性可提升歐美國家對產品的信任度。但內需市場太小，資本額不足為台灣眾多中小企業的共同劣勢。專注海外華人市場，與當地廠商進行策略聯盟，可能是進軍國際市場的競爭方式之一。從法規面而言，健康食品法規定義明確且詳細，審查單位專業嚴謹，對於健康產業與消費者都是一種良性的助力，但保健功效評估方法項目不足、審查時間過長與健康食品的知識教育，都需要政府單位持續努力及完善的規劃。 As the economy and the standard of living improve, the demand for health and wellness is rapidly increasing. Under the influence of the traditional Chinese concept of health, the functional food grows quickly and becomes a flourishing industry in Taiwan. According to the flourishing of functional food industry, Taiwan government legislated the law of Health food to strengthen the supervision and control in 1999. However, there are only four hundred registered Health Foods until now. This study focused on the requirements that may be unsatisfied in the regulatory affairs on Health Food by searching the laws and the competent authorities of Health Foods and related products. Chapters 2 to 5 introduce the supervision and control systems of health foods and related products in Taiwan, China, the United States and Australia. Each chapter start from the development status of health foods in these countries, then discuss the administrative of the competent authorities. Above all regulatory, this study focused on approval processes, scientific efficacy verification and the appropriate product labeling and advertising. Chapter 6 compares the different between Taiwan, China, the United States, and Australia by the approval processes, health claims, and labels of Health Food and its related products, and analysts the strengthen and weakness of Taiwan health industry and regulation system. From an industry perspective, the characteristics of emphasizing on academic research and quality management can win the trust of occidental world on products. However, the small domestic market and the lack of capital are common disadvantages for many Small and medium-sized enterprises in Taiwan. Focusing on the overseas Chinese market and conducting strategic alliances with local manufacturers may be the solutions to involve in the international market. In terms of regulations, the health food regulations are clearly defined and detailed, and the review units are professional and rigorous. They are a benign help to the health industry and consumers, but the government need to make more efforts on the insufficient health care efficacy assessment methods, the procrastination of examination, and the inadequate health food knowledge education by well planning.
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