ABSTRACT This study mainly talks about the relationships between outsourcing and developing opportunities of China pharmaceutical industry. The research background is current situations of the world pharmaceutical industry and pharmaceutical industry in China. The aim of our study is to raise some strategic proposals for China pharmaceutical industry development through carefully looking into pharmaceutical outsourcing. Meanwhile, we also expect that our study can introduce the new concept of outsourcing into China pharmaceutical market, and help Chinese drug companies to adjust their traditional ways of running business. In order to reach those objectives, we brought up 5 questions and answered them respectively. Those 5 questions are: (1) What is outsourcing? (2) Why pharmaceutical outsourcing can help China pharmaceutical industry to grow bigger and stronger? (3) What does the world pharmaceutical outsourcing market like? (4) What is the competition like in pharmaceutical outsourcing market? (5) How can China pharmaceutical industry take full advantage of the developing opportunities by promoting pharmaceutical outsourcing? In the first section, we compared outsourcing with traditional industrial structure adjustment. After comparing their definitions and the implementary effectiveness, we found obviously differences on how they affect the target industry. The conclusion is that outsourcing can substantially promote growth in problem industry. In the second section, we proved that outsourcing can relieve the great financial pressures in the world pharmaceutical industry, and it can also actualize the potential value of this industry. In this section, we also proved that pharmaceutical outsourcing can help China pharmaceutical industry to enter the global market and eventually become competitive. In the third section, we collected a large amount of data and screened out useful market information to form the whole picture of the pharmaceutical market. Contract research and contract manufacturing were mainly studied, since they are the biggest business sections in the whole business process. After that, we analysed the competition circumstance and the main competitors in pharmaceutical industry market, and we assessed the competitive abilities of China pharmaceutical industry as well. By studying the market and competitors in it, we found that China pharmaceutical industry has competitive advantages in contract manufacturing. In the last section, we raised several strategic proposals to take good advantage of the opportunities which are created by pharmaceutical outsourcing. We suggested that the drug regulation infrastructure should be more compatible for pharmaceutical outsourcing, and more compliant to the international drug regulation system. We also suggested Chinese drug companies to open their minds and join in pharmaceutical outsourcing business. In order to make all those suggestion feasible, we redesigned the drug regulation system and described it in details. We hope our study can be fully considered when new drug policies are made. KEY WORDS Outsourcing, Pharmaceutical Industry, Strategic Study, "Double-layer Drug Standard", "Diversified Regulatory System"

摘要 本研究是以目前世界制藥業的整體形勢以及我國制藥業的現實狀況為產業背景,針對業務外包這一新型的管理理念和經營模式在我國制藥業內的開展,以及它對我國制藥業國際競爭力提升的作用和機制等問題做了初步的探討。整個研究以業務外包為線索,從業務外包概念的介紹、業務外包與制藥業、制藥業業務外包、以及制藥業業務外包所帶來的對產業發展策略的思考等幾方面內容,具體闡述了業務外包與中國制藥業的發展機會之間的關係。 開展本研究的主要目的是通過具體論述業務外包給中國制藥業帶來的發展機遇,為我國制藥業的現代化發展和國際競爭力的提升提出策略建議和意見參考。同時,通過對業務外包是如何促進我國制藥業發展的理論分析,並結合產業經濟學和競爭力理論的普遍規律,向中國制藥業界介紹開展業務外包思路,推動產業界經營和發展觀念的轉變。 在對業務外包概念的研究中,文章對業務外包與傳統產業結構調整進行了比較, 認為二者具有顯著的區別,他們二者對於被調整產業的具體處置方式不同,這也就導致了被調整產業的發展方向的差異。業務外包所調整的產業的發展狀況,無論從規模還是質量都較傳統產業調整要更優。 文章接下來論證了業務外包不僅可以解決制藥業發展過程中日益嚴重的財務壓力,而且可以為制藥業實現潛在價值,從而促進制藥業的發展。在業務外包給中國制藥業發展問題上,本文以業務外包的一種具體形式——委託生產為例,證明瞭委託生產不僅可以優化中國制藥業的產業鏈,還能全面提升中國制藥業的國際競爭力。 通過廣泛收集國際制藥業產業的數據和資料,本文對國際制藥業務外包市場進行了整體評價和預測,認為藥物委託生產和委託研發的市場剛剛進入高速發展階段,前景廣闊。針對我國制藥業如何迅速國際制藥業務外包市場,本文運用 SWOT分析法 對我國制藥業進行了實證研究,並得到如下結論:(1)我國制藥業具有進入國際制藥業務外包市場的比較優勢,極具市場發展潛力;(2)我國最有潛力的制藥業務外包市場為藥物的委託生產業務;(3)提升我國制藥業務外包競爭力的關鍵是政府的藥品監管體系建設以及行業發展觀念的改變。 基於對制藥業務外包市場的研究和我國制藥產業發展狀況的分析,文章認為通過在國內開展制藥業務外包服務是有利於我國制藥業整體素質提升和實現產業的跳越式發展的。針對如何實現業務外包在國內制藥業的開展問題,文章認為首要的問題是健全相關法律法規,使之能有效的規範和管理制藥業務外包和適應其發展需要。文章還提出了“雙層監管標準”和“差別監管體制”的藥品監管體系改造構想,並以此為基礎提出了“中國制藥業國際競爭力提升戰略”以供政策制定者參考。 關鍵字 業務外包 制藥業 策略研究 雙層監管標準 差別監管機制