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研究生:郭聯耀
研究生(外文):Lien-Yao Kuo
論文名稱:國內藥廠實施PIC/SGMP後競爭優勢之探討
論文名稱(外文):A Study of Competitive Advantage for Domestic Pharmaceutical Factory after the PIC/S GMP
指導教授:鍾燕宜 博士吳成豐 博士
指導教授(外文):Yen-Yi Chung, Ph. D.Chen-Fong Wu, Ph. D.
學位類別:碩士
校院名稱:靜宜大學
系所名稱:管理碩士在職專班
學門:商業及管理學門
學類:企業管理學類
論文種類:學術論文
論文出版年:2010/07/
畢業學年度:98
語文別:中文
論文頁數:105
中文關鍵詞:製藥業PIC/S競爭策略競爭優勢GMP
外文關鍵詞:PIC/SPharmaceutical IndustryGMPCompetitive AdvantageCompetitive Strategy.
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攸關人類身體健康及安全之醫藥產品,政府為求促進國內藥廠製藥品質之提昇及接軌國際市場,衛生署於2007年公佈PIC/S GMP實施時程,預定將於2015年全面實施。目前PIC/S GMP之制定是國際GMP共通提昇之規範標準,全球化已是現今世界各國無法抵擋之趨勢,各國政府保護自己國人之健康,訂定互有差異之GMP規範。為求各國GMP規範能夠相互協同合作,近年歐盟致力推行會員國間GMP國際協同及標準一致化之查廠規範「PICS」(Pharmaceutical Inspection Co-operation Scheme)。未來醫藥品之GMP規範,趨向國際一致化之標準,促進各國產品在國際市場流通更加順暢。
相對國內製藥業,原來承受健保藥價支付制度及進口藥品擠壓與GMP規範束縛等因素,加上缺乏關鍵技術、藥廠家數眾多、生產設備未具經濟規模,惡劣環境下,各廠家經營困難,業績難以擴展。未來國內藥廠實施PIC/S GMP後,能夠避免限縮國內藥品市場,拓展製藥產業版圖,推展進入國際市場,值得業界值得深思及因應之議題。

本研究是以國內外製藥產業發展趨勢與產業政策環境分析,並與國內四家藥廠主要負責研發、行銷、營業高階主管深度訪談後,彙整提供業界面對製藥產業困難經營環境之因應對策,包括差異化目標市場策略、產品技術發展策略、策略聯盟與國際化策略等四大策略發展方向,尋求關鍵營運之競爭優勢發展最有利的競爭策略,促成製藥產業突破困境,更加進步與發展。
The pharmaceutical products are related to human health and safety, the Government seeks to promote the domestic pharmaceutical companies to enhance the pharmaceutical quality and integration of international markets, the Department of Health published in 2007, PIC/S GMP implementation timetable, expected to be fully implemented by 2015.
The current PIC/S GMP of the development is to enhance the international GMP standard common standards, globalization is now the world can not resist the trend, governments protect their citizens of health, there are differences between each set of GMP standard. GMP norms for the sake of national collaboration with each other in recent years, the EU committed to international collaboration between Member States and GMP standards factory inspection line of the standard "PICS" (Pharmaceutical Inspection Co-operation Scheme). The future of pharmaceutical GMP standards will become harmonization towards international standards, promoting products flow more smoothly in the international market.
Relative domestic pharmaceutical industry, the original drug prices affordable health insurance payment system and regulate imported drugs bound GMP extrusion and other factors, lack of key technologies, the numbers of large drug manufacturers, production equipment, not economies of scale, poor environment, the factory management difficult, performance is difficult to expand. Future implementation of the domestic pharmaceutical PIC / S GMP, it can avoid the restrictions reduce the domestic pharmaceutical market, to expand the territory of the pharmaceutical industry, and to promote access to international markets, the industry is worth serious consideration and how to respond to this issue.
This study is the development of international and domestic pharmaceutical industry and interview the four major domestic pharmaceutical companies responsible for the R & D, Marketing, Business Executives. To provide the difficulties faced by the industry operating environment due to response strategies, the goal of marketing strategy includes difference, product technology development strategy, strategic alliances and international strategic of the direction of the four strategies. The key competitive advantage for business in the best interest of competitive strategy, to promote pharmaceutical breakthrough difficulties, more progress and development.
中文摘要......................................................................................I
英文摘要.....................................................................................II
目錄...........................................................................................IV
表目錄.......................................................................................VI
圖目錄....................................................................................VIII

第一章 緒論...............................................................................1
第一節 研究背景與動機.......................................................1
第二節 研究目的...................................................................2
第三節 研究對象與範圍.......................................................3
第四節 研究限制...................................................................3
第二章 文獻探討.......................................................................4
第一節製藥產業特性與PIC/S GMP規範............................5
第二節 競爭策略與競爭優勢相關文獻.............................12
第三節 資源基礎理論相關文獻.........................................21
第四節 產品技術發展策略相關文獻.................................25
第五節 策略聯盟與國際化策略相關文獻.........................28
第三章 研究設計.....................................................................32
第一節 研究流程.................................................................32
第二節 研究範圍.................................................................33
第三節 研究方法.................................................................33
第四節 研究架構.................................................................34
第四章 製藥產業總體環境發展分析.....................................35
第一節 全球製藥產業概況.................................................35
第二節 台灣製藥產業概況.................................................45
第三節 製藥產業政策環境分析.........................................53
第五章 個案公司分析.............................................................59
第一節 永信藥品工業股份有限公司.................................59
第二節 台灣東洋藥品工業股份有限公司.........................65
第三節 友華生技醫藥股份有限公司.................................70
第四節 美時化學製藥股份有限公司.................................76
第六章 競爭策略之選擇.........................................................82
第一節 訪談結果分析.........................................................83
第二節 競爭策略之選擇.....................................................88
第七章 結論與建議.................................................................93
第一節 結論.........................................................................93
第二節 建議.........................................................................95
第三節 研究限制與後續研究.............................................98
參考文獻...................................................................................99
(一)中文文獻.........................................................................99
(二)英文文獻.......................................................................101
深度訪談問卷.........................................................................104
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