東協學名藥品法規解析

中國醫藥大學機構典藏 China Medical University Repository, Taiwan > 藥學院 > 製藥碩士學位學程 > 博碩士論文 > Item 310903500/58367

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题名:	東協學名藥品法規解析 ASEAN Regulatory Affairs Study on Generic Drugs
作者:	邱君慧;Chun-Huei Chiu
贡献者:	製藥碩士學位學程
关键词:	學名藥法規;東協;ACTD;ACTR;Generic drug regulation;ASEAN market
日期:	2017-08-23
上传时间:	2018-01-29 15:52:13 (UTC+8)
出版者:	中國醫藥大學
摘要:	2015年12月31日成立的東協經濟共同體(ASEAN Economic Community,AEC)為後起之秀，繼全球最大經濟共同體—歐盟之後，為全球人口僅次於中國和印度及全球生產毛額第七大的經濟體。學名藥(Generic Drug)，本研究的主要類別，在各國政府為節約醫療開支，鼓勵使用學名藥政策下，BMI(Business Monitor International)研究機構預測全球學名藥市場在2020年將達3,953億美元。台灣本土的西藥製劑廠多為學名藥廠且以內銷市場為主，每家藥廠生產品項繁多且與他廠重疊性高，如何在國內銷售市場有限但生產成本又因PIC/S升級而遽增的情況下維持營運，成了國內各家學名藥廠重要課題。觀察全球跨國學名藥廠的經營模式，發現除了彼此間藉著互相併購以整合研發、生產及銷售通路外，積極的開拓海外市場增加銷量以達到生產經濟規模也是這些學名藥大廠的選項之一。台灣屬於高度依賴貿易的海島經濟國，本研究即以台灣學名藥廠拓展外銷市場的需求並配合台灣新南向政策，系統性分析和歸納東協各國學名藥查登的相關規定，提供有意拓展東協藥品市場的廠商進軍東協的入門指引。 ASEAN Economic Community, AEC, established on 31 Dec., 2015 and becomes rising start after the world’s lagest economic community-European Union. AEC’s population is the 3rd largest community that is less than China and India while its GNP is the 7th economic community. Generic Drug, the subject of the study, is a promising industry due to encouragement policy of generics usage from governments all over the world. According to BMI (Business Monitor International) survey, the global generics market will reach US$395 billion in year 2020. In Taiwan, local pharmaceutical manufacturers are mostly producing generics and focusing domestic market. Their product portfolios are similar so the product price is very competitive. How to maintain the business operation under the condition of increasing production cost and limited local market size is a tough challenge. To observe the global multinational generic drug companies’ business modle, except mutual acuqtions to integrate research & development, production and sales channels, to expand overseas markets to achieve the scale of production economies is another option. Taiwan is an island-economic country which depends highly on foreign trade. Under Taiwan government “New Southern Policy” and the expanding market needs of generic-drug manufacturers expanding overseas markets, the study is systematic analysis the pharmaceutical regulation in ASEAN countries to provide a guidance of pharmaceutical registration for those stakeholders who are interested in ASEAN market.
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