生技產業被視為二十一世紀的明星產業，特別是在醫療進步下，不但使整體生活的提升，國人平均壽命增加，更讓健康養生觀念日益重視。而這些有利因素為生技產業帶來美好的發展前景，並成為各方期待的明星產業。 生技產業具備高經濟效益、高技術性，低污染、低耗能的特性。生物科技產業是相當強調研發創新的產業，研發活動的主要成效表現在新應用技術的產生、產品品質的提升等方面。整體生物技術產業的研發經費支出因相對較其他產業高，故新技術或新產品的研發能力可說是其主要的競爭優勢，但研發期長也造成成本累積，而使公司面臨經營上的風險。 1997年發生亞洲金融危機後，國內、外相繼爆發不少企業醜聞，不但影響整個經濟環境，更讓投資大眾的權利受損，亦凸顯公司治理對企業管理經營上的重要性。內部控制已深受許多企業廣泛之應用。在現行內部控制的運用下，其對於各控制項目之要求已有明確規範，並對公司運作有極大的幫助與效益。因此，本論文以內部控制五大要素：控制環境、風險評估、控制作業、資訊與溝通、監督來分析個案生技醫藥產業之內部控制機制，希望藉由個案實際運作分析可作為其他生技公司之參考。 The bio-tech industry is viewed as the most potential industry. With the development of medical science, we not only have a better standards of living and a longer life span, but also that we put more emphasis on how to maintain a healthy life style. It is also because of these favorable factors that promise a prosperous future for bio-tech industry and make it a rising-star industry. The bio-tech industry features high economic benefit, high technological level, low pollution, and low energy consumption. Innovation is always the priority of this industry. The main outcomes of R&D are the introduction of new application and the enhancement of products’ quality. The R&D expenses in this industry is higher than others industries, therefore the abilities of introducing new technology and developing new products are it’s main competitive edges. However, the long-term accumulation of R&D costs may result in a financial risk for the operation of business. After the Asian financial crisis in 97, the outbreak of several business scandals not only has a negative impact on the overall investing environment and the investors, but highlights the importance of corporate governance for the business. Nowadays the idea of internal control is widely adapted by many businesses. This thesis uses the five controlling factors of internal control: controlling environment, risk evaluation, controlling operation, information & communication, and supervision to analyze the mechanism of internal control in bio-tech and pharmaceutical industries. Last but not least, we also hope the case study may offer some hands-on experience for other bio-tech companies.