The establishment of the inner circle of new drug research and development is proportional to the economic strength of the country, In nineteen countries with the most powerful economic strength in the world as America Swiss Japan and etc formed the global inner circle of new drug research and development in the 1980’s. Iceland Ireland and other countries joined the inner circle from 80’s to 90's. With the rapid growth of the economic strength of the country from the end of 90’s, China India and other countries have show the strength, It is a strategic timing that China should seize to improve the ability of research of pharmaceutical industry. Meanwhile, the strategy of government and the choice of corporation are equally important. At present, numerous attempts have been made to analyze the R&D situation of Chinese Pharmaceutical Industry (CPI) by the similar conclusions have been reached, such as, the lack of the R&D funding, the extra repeated development at the low level, the too long reviewing process, and so on. However, little attention is given to apply the statistics method, economics theory, and management theory to systemically study the CPI. On the contrary, the medical administration study by the foreign scholars has reached a higher research level by many professional analysis instruments and methods and model research. The thesis evaluates the CPI R&D capability and performance by the application of the quantitative analysis method and the establishment of the rational evaluation indexes system. The thesis includes the following main contents. 1 To analyze the CPI R&D data by the establishment of the R&D evaluation system. This work vitally includes the theoretical analysis by Chapter 1 and the practical analysis by Chapter 3. In the Chapter 1, the basic theory of the technology innovation system and the impact factors of the R&D capability are reviewed. It is concluded that the evaluation system to the R&D capability and performance should include the capability indexes, represented by the R&D intensity and scale and stock, and the performance indexes, showed by the patent number, the field number, the efficiency index, the innovation index, and the labor productivity. In the Chapter 3, these indexes are calculated on the basis of the CPI data. This chapter demonstrates the poor situation of the CPI R&D with the special emphasis on the R&D intensity index of 2.6. Fortunately, the CPI R&D level has the rapid development, for example, the growth ratio of the CPI R&D input is 20.87% from 1997 to 2002, which is rapider than the developed countries. 2 To compare the new drug R&D situation of the different countries. The part is showed on the comparative study on the drug R&D of the Chinese and the other countries by the Chapter 3, and the drug R&D introduction of the main countries by the Chapter 2, The Chapter 2 analyzes the drug R&D situation and the strategies of the government and enterprise in the USA, the Japan, the EU, and the India, Besides, the ICH is also introduced in this part. The chapter presents the drug R&D details in the every country from the following aspects of the input capital, the manpower, the supervision and administration departments, the government and enterprise, and the R&D strategies, and so on. The EU part introduces the new drug R&D situation of the English, the Germany, the France, and the Italy with the special emphasis on the English by the quantitative method. 3 To put forward the Chinese new drug R&D strategies on the basis of the former chapters by the case study method, The Chapter 4 puts a case about the new drug R&D strategies of the Shanghai Tianwei Bio-pharmaceutical Firm, controlled by the Shanghai Modern Pharmaceutical Limited Corporations. The company has been developed from the started registered capital, 10 million RMB, to total capital after the 3 years, 59.89 million RMB by the favorable R&D strategies and environment, The case gives us a good example of the CPI R&D. Based on the positive analysis, the case study, and the comparative analysis, the Chapter 5 puts a detailed study on the new drug R&D strategy of CPI. This part can be divided into the following 4 sections. Firstly, as far as the domestic capital enterprises are concerned, the big firms with the powerful competitiveness should implement the united R&D strategy, and the super huge company with the excellent performance should apply the inner R&D strategy, and the small business may carry out the technology introduction strategy. Secondly, about the foreign capital firms, their R&D activities in China are benefit to improve the R&D level of CPI; therefore, the Chinese government should encourage these activities. At the same time.it is of great importance to create a fair competition environment in order to avoid the super national treatment, The Chinese technology improvement should depend on the increase of the Chinese technology innovation capability. Thirdly, about the role of the government in the R&D, we should introduce the following three foreign models and impel the role of the intermediary organizations. The first model, named the USA model, is that the government only creates a favorable innovation environment without the special technology innovation policies by government. In a word, the innovation is driven by the market system. The Japan model is that the government directly participates the technology innovation activities with the special technology police by the Japan government. It is interesting that the EU model is in the middle of the former two models. Finally, the other strategies are analyzed, such as the positive financial policy, the finance support policy, the patent policy, the public procurement policy, the small and middle enterprises .policy, and so on. Keyword: R&D innovation system, R&D performance, R&D strategy, Drug R&D, China

新藥研發核心國家的確立與各國經濟實力成正比。二十世紀八十年代，經濟實力雄厚的美國、瑞士、日本等十九個國家處於全球新藥研發核心圈；八十至九十年代，冰島、爱爾蘭等國加入這一核心圈；九十年代末以來，随著經濟實力的迅速增長，中國、印度等國已顯示出加入這一核心圈的實力。因此我國要抓住這個戰略时機提高醫藥產業的研發能力。同時，政府戰略和企業選擇也同樣重要。 目前，國内對於醫藥產業界现状的分析多採用比較泛的綜述的方法進行論述，大多數文章關於產業界缺研發投入、低水準重複、審批時間長等類似的結論。而採用統計學方法結合經濟學、管理學理論系統地對醫藥產業進行分析的文章非常少。國外對於醫藥產業及相關領域的研究分析已經進展到將醫藥管理這個大專業研究的方法學研究及理論研究上升到一門專業課的水準。現在國外的分析中很多採用量化及模型研究。本研究採用量化方法进行資料分析，對我國醫藥產業能力及績效的評估是建立在詳實的資料資料基礎上的並採用比較合理的評價指標體系進行科學计算分析。 本文一共分五個章節，是相互聯繫的一個有機整體。主要内容： 1、採用R&D理論指標評價體系對中國醫藥產業研發相關資料進行分析、評價。這一部分內容由第三章的實證分析呼應第一章的理論及量化指標體系成。第一章中概述研發理論來源於國家創新體系中由以企業爲主體的技術創新體系基礎理論和研發影響因素；研發能力和績效評價體系包括：能力指標：強度、規模、存量；績效指標：專利文獻數、領域數、效率指数、创新指数、勞動生產率。在第三章中用這些量化指標對中國醫藥產業研發狀況進行分析計算，如分析計算出我國的研發强度絕對指標是2.6，在主要制藥國家中如美、英、德、英、法、加、意、韓這些國家的比較中排名最後。但是採用強度比較相對指標發現結果並不如國内多數研究結果所得到的那麽悲觀，從1997到2002年間我國醫產業研投入年均增长率20.87%，在這些國家中居於首位且高於國内政府機構的投入(國内研發機構18.76%，高等學校12.78%)。 綜合各項指標的分析結果，目前在投入方面正在加強，但是效率方面還是比較差。我國醫藥產業的研發状況並不是如目前國内大多数的論文說得的那麼悲觀。 2、分析主要國家地區新藥研發狀況並採用相對指標與中國進行比較分析。這一部分内容由第三章的中國與各國實證比較分析呼應第二章的各主要國家地區的醫藥產業研發狀況構成。第二章主要分析了美、日、歐盟、印度新藥眼領域的现状和政府企業的策略，並介紹了重要組織ICH(國際人用藥品註册協调會)的状况。每一個國家和地區的介紹都非常詳細，包括研發資金、人力、監管機構及沿革、政府和企業的狀況和研發策略等方面。如欧盟部分介紹了英、德、法、意等的新藥研發狀况，尤其對英國的新藥研發狀況作了具體的量化分析。在第三章中採用相對指標把部分國家的研發状況同中國做了量化的比較分析。 3、結合案例分析並在前幾章研究分析的基礎上提出我國醫藥產業新R&D策略。第四章的案例分析主要寫了上海現代制藥股份有限公司下屬的上海天偉生物制燊有限公司發展過程中研發策略的推動作用案例。上海天偉生物制藥有限公司 天偉生物設立時註册資本爲人民1,000 萬元·在短短三年時間裹通過良好的研發策略及外部環境，截至2003年12月31日，天偉生物資座到5,989.44 萬元。案例分析其在發展過程中的良好的研發策略以及存在的一些問题，對於我國的醫藥產業具有很好的借鑒意義。 在實證分析、案例分析、中外比較分析後在第五章詳細展開論述我國醫藥產業的新藥研發策略。策略主要有：一、針對內資醫藥企業的研發戰略：初具規模、具備一定競争力的大型企業、外向型高科技企業採取聯合R&D戰略；業績優秀、富有社會责任感的超大型企業採取内部R&D戰略；規模、技術、資金、人才都不足的中小型企業可以採取技術引進戰略。二、針對外商獨資、合資制藥企業的在華研中心展戰略：跨國藥企在華設立R&D中心對中國醫藥產業研發水準的升級有較大貢獻，政府應該支援中國醫藥產業積極融入跨國制藥公司研發活動之中。同時要创造一個内外資研發的一個公平的競争環境，避免給予外资研發超國民待遇。中國的技術進步更多地要依賴于本土自主技術創新能力的提高。三、政府政策的原則導向問题(非直接幹預而是間接影響)：借鉴國外三種模式和市場仲介機構(如行業組等)對我國醫藥研發產業展開有效的引導。三種模式：美國模式，政府不制定專門的技術創新政策，主要通過市場機制來完成創新，政府的作用是為企業提供、管造良好的新環境；日本模式，政府直接介入技術创新活動，並制定專門的政策；欧洲模式:介於美日兩者之間。目前三種模式互相参考學習，界限已模糊。四、其他具體策略：包括财政刺激政策、金融支持政策、專利保護政策、公共採購政策、中小企業政策等。 關鍵字：研發體系 研發績效 研發策略 新藥研發 中國