近年來在相關產業與政府的努力及人才培育之下，我國許多生技研究已有初步的規模且可說是居於亞洲領先地位。然而，這些技術在商品化應用的階段卻一直沒有重大突破與發展，難以將研發成果的實質效益挹注到產業中。研發成果商品化的過程中，必須兼備技術面、法律面、財務面、管理面的考量，面面俱到才能將初萌的技術逐步發展為成熟的商品，進而在市場上獲取實質利潤，再將獲得的資源挹注於研發活動，形成良性循環。 研發成果商品化的策略視產業特性而截然不同，在「生技醫療產業」中，因其具有「受衛生主管機關高度管制」、「商業化認證需時」、「行銷國際化」的特性，在法規面的複雜度較高，且為專案成功與否的關鍵因素之一，進行商品化評估時必須熟悉相關醫藥法規，才能著手為專案發展做正確的規畫 ，極度仰賴「跨領域」、「高度技術」與「熟稔特殊商業技巧」的人才。依各國藥物法規的不同，商品化的開發時程也受此影響，生技製藥產業之技術及研發成果必須將為達到法規規範的要求而必須投入的時間、資金、人力等各項資源納入總體可行性評估之考量依據。。因法規具有地域性，本研究無法齊備全球各國，將以美國及台灣為研究主體，台灣的法規深受世界公認醫藥法規先進的美國影響，熟知美國的法規可以預估台灣法規機構的思路；且美國藥品市場佔全世界最大規模，此外，美國也極有可能成為潛在合作廠商之所在地，因此本研究將比較美國與台灣之醫藥法規，並評估在技術研發的過程中，衛生主管機關之要求對於技術商品化過程中所產生的影響。 明確、具科學性、可預期性的法規環境能降低製藥產業於研發過程中的不確定性，提高廠商投入的意願。衛生醫療政策及藥政管理政策直接影響到醫藥法規的訂立，政府制定的法規將引導產業發展的方向，對於藥品市場有極重要的影響。一個好的政策應該能夠與國家的總體背景相匹配，法規要求應與國家發展程度及國家內需市場成比例。台灣生技製藥產業目前的困境之一，就是國內廠商在開發新藥時，為了符合台灣衛生主管機關訂定的高標準法規必須投入更多的成本，但台灣卻沒有足夠的內需市場得以支撐，造成擁有豐厚資源的國外廠商可以將符合世界（十大先進國）高標準的藥品進入台灣市場，但國內廠商卻無法立足。為解決此困境，台灣廠商一定要設法將業務範圍擴大到外需市場，以獲取足以支持藥物發展所需的資金成本。因此，了解國內、外之藥物相關法規，做出能符合各國法規要求的產品，為踏出國際外銷市場的第一步；此外，各國的智財法以及與商業相關的法律，還有其之間的互相關聯，都是技術商品化是否能夠成功至為重要的關鍵因素。本文擬就藥物法規面為討論之主軸，其間輔以智財、商業相關構面，對生技製藥產業之技術商品化之過程做一探討。在本研究所選的個案—核子醫學藥物，是眾多創新產品的一種，如果能把握技術、智財、法規、法律、國際商業運作，很有可能為台灣的藥業打開另一片天。 / In recent years, we have already developed some achievements in biotech researches in Taiwan and are in a leading position in Asia under the efforts of government and industries. However, these technologies still are slowly developed to the commercialized phase. Thus, the achievement of these researches does not benefit industry substantially. In the process of commercialization of biotech research, we have to consider all the aspects, including technology and regulation, intellectual property, finance and management. With a well-rounded development plan, technologies in the bud will gradually develop to a mature commodity, and earn fiscal profit in the market. The profit will consequently contribute to research activity. A virtuous circle will be formed. The strategies of commercialization differ considerably among industries. Regarding biopharmaceutical industry which has the properties of highly regulated by competent authorities, time consuming, heavy capital, and global marketing, the regulation assessment is not only complicate but also critical to project implementation. The required documents according by regional authorities will be a decisive factor to consider the development plan including the estimated timetable, needed resources. Due to the regulation system in US affected a lot legislation for laws in Taiwan , America and Taiwan will be the prior topics in this research. A well-developed legal framework and protection of intellectual property rights is the prerequisite for building an ideal environment where the biotechnology and pharmaceutical industries can flourish. In order to improve the environment for these industries, in recent years the government has approved the amendment and execution of related laws and regulations. Amendments have been made to related tax benefit and incentive measures of investment. Other amendments have been made which have allowed R&D results to be more easily transferred to academia and industry. Looking into the future, under the joint cooperation of industry, academia and research institutes, and with the government’s policy to fully promote the sector, it is believed that Taiwan will have well developed in the near future.