Act for the Development of Biotech and Pharmaceutical Industry Article 4
For the purposes of this Regulation, the following definitions apply:1.“Biotech and Pharmaceutical Industry” refers to the industry that deals with New Drugs, New Dosage Forms, High-Risk Medical Devices, Regenerative Medicine, Precision Medicine, Digital Medicine, Innovative Technology Platforms Dedicated to Biotech and Pharmaceutical Industry and Other Strategic Biotech and Pharmaceutical Products used by human beings, animals and plants.2.“Biotech and Pharmaceutical Company” refers to a company in the Biotech and Pharmaceutical Industry that is organized and incorporated in accordance with the Company Act and engages in any of the following business activities approved by the Competent Authority:(i)the research, development and manufacture of New Drugs, New Dosage Forms, High-Risk Medical Devices, Regenerative Medicine, Precision Medicine, Digital Medicine, Innovative Technology Platforms Dedicated to Biotech and Pharmaceutical Industry and Other Strategic Biotech and Pharmaceutical Products; and(ii)the contract development and manufacture of New Drugs, New Dosage Forms, High-Risk Medical Devices, Regenerative Medicine, Precision Medicine, Digital Medicine and Other Strategic Biotech and Pharmaceutical Products.3.“New Drug ” refers to a drug that has a new ingredient, a new therapeutic effect or a new administration method, and “New Dosage Form” refers to a new dosage form of a pharmaceutical preparation, as approved by the central governmental authority in charge of the industry concerned.4.“High-Risk Medical Device” refers to a Class III medical device or a Class II medical device of which the approval requires clinical trials, as approved by the central governmental authority in charge of the industry concerned.5.“Regenerative Medicine” refers to a drug, medical device, product or technology that uses cells or genes to reconstruct or repair the structure or function of the human body for the purpose of treatment or prevention of diseases, as approved by the central governmental authority in charge of the industry concerned.6.“Precision Medicine” refers to an innovative product or technology that analyzes the relationship between the physiological and pathological characteristics of an individual and the mechanism and extent of a disease through genetic sequencing, molecular identification, metabolite analysis or other omics-based tests, in order to provide predictive, preventive, diagnostic and therapeutic functions for treating diseases, as approved by the Competent Authority in conjunction with the central governmental authority in charge of the industry concerned.7.“Digital Medicine” refers to an innovative product or technology that is applied in the field of healthcare with big data, cloud computing, Internet of Things (IoT), artificial intelligence and/or machine learning technologies, and is used to enhance the prevention, diagnosis and treatment of diseases, as approved by the Competent Authority in conjunction with the central governmental authority in charge of the industry concerned; provided that the medical device software of artificial intelligence or machine learning technology shall be subject to the approval of the central governmental authority in charge of the industry concerned.8.“Innovative Technology Platforms Dedicated to Biotech and Pharmaceutical Industry” refers to a platform for products or technologies with high research and development (“R&D”) risk, importance and innovation that specializes in the research, development and manufacture activities identified in Subparagraph 3 or 5 above, or in the development and manufacture of New Drugs, New Dosage Forms or Regenerative Medicine identified in Item (ii) of Subparagraph 2 above, as approved by the Competent Authority in conjunction with the central governmental authority in charge of the industry concerned and the Ministry of Finance.9.“Other Strategic Biotech and Pharmaceutical Product” refers to a biotech and pharmaceutical item having a strategic development direction designated by the Executive Yuan and announced by the Competent Authority after being approved thereby.Regarding the Biotech and Pharmaceutical Company referred to in Subparagraph 2 of the preceding paragraph, the approval criteria, the documents required to be submitted, the application procedures for approval, the revocation or termination of the approval, and other relevant matters shall be prescribed by the Competent Authority.
中文原文 生技新藥產業發展條例第4條
本條例用詞，定義如下：
一、生技醫藥產業：指用於人類與動植物用之新藥、新劑型製劑、高風險醫療器材、再生醫療、精準醫療、數位醫療、專用於生技醫藥產業之創新技術平台及其他策略生技醫藥產品之產業。
二、生技醫藥公司：指生技醫藥產業依公司法設立之公司，從事下列業務之一，並經主管機關審定者：
（一）研發製造新藥、新劑型製劑、高風險醫療器材、再生醫療、精準醫療、數位醫療、專用於生技醫藥產業之創新技術平台及其他策略生技醫藥產品。
（二）受託開發製造生產新藥、新劑型製劑、高風險醫療器材、再生醫療、精準醫療、數位醫療及其他策略生技醫藥產品。
三、新藥、新劑型製劑：指經中央目的事業主管機關審定屬新成分、新療效複方或新使用途徑製劑，及新劑型製劑之藥品。
四、高風險醫療器材：指經中央目的事業主管機關審定屬第三等級之醫療器材或須經臨床試驗始得核准之第二等級之醫療器材。
五、再生醫療：指將細胞、基因用於人體構造、功能之重建或修復，以達到治療或預防為目的，並經中央目的事業主管機關審定之藥品、醫療器材、產品或技術。
六、精準醫療：指透過基因定序、分子鑑定或代謝體分析等之體學檢測，分析個體之生理病理特性與疾病機制及程度之關係，以提供疾病之預測、預防、診斷及治療功能，並經主管機關會同中央目的事業主管機關審定之創新性產品或技術。
七、數位醫療：指以巨量資料、雲端運算、物聯網、人工智慧、機器學習技術應用於健康醫療照護領域，且用於提升疾病之預防、診斷及治療，並經主管機關會同中央目的事業主管機關審定之創新性產品或技術。
但屬人工智慧或機器學習技術之醫療器材軟體，由中央目的事業主管機關審定。
八、專用於生技醫藥產業之創新技術平台：指專門應用於第三款或第五款之研發製造，或提供第二款第二目之開發製造新藥、新劑型製劑或再生醫療，並經主管機關會同中央目的事業主管機關及財政部審定之具高度研發風險、關鍵性及創新性產品或技術之平台。
九、其他策略生技醫藥產品：指經行政院指定為具策略性發展方向之生技醫藥項目，並經主管機關審定後公告者。
前項第二款生技醫藥公司之審定要件、應備文件、程序、審定之撤銷或廢止及其他相關事項之辦法，由主管機關定之。
一、生技醫藥產業：指用於人類與動植物用之新藥、新劑型製劑、高風險醫療器材、再生醫療、精準醫療、數位醫療、專用於生技醫藥產業之創新技術平台及其他策略生技醫藥產品之產業。
二、生技醫藥公司：指生技醫藥產業依公司法設立之公司，從事下列業務之一，並經主管機關審定者：
（一）研發製造新藥、新劑型製劑、高風險醫療器材、再生醫療、精準醫療、數位醫療、專用於生技醫藥產業之創新技術平台及其他策略生技醫藥產品。
（二）受託開發製造生產新藥、新劑型製劑、高風險醫療器材、再生醫療、精準醫療、數位醫療及其他策略生技醫藥產品。
三、新藥、新劑型製劑：指經中央目的事業主管機關審定屬新成分、新療效複方或新使用途徑製劑，及新劑型製劑之藥品。
四、高風險醫療器材：指經中央目的事業主管機關審定屬第三等級之醫療器材或須經臨床試驗始得核准之第二等級之醫療器材。
五、再生醫療：指將細胞、基因用於人體構造、功能之重建或修復，以達到治療或預防為目的，並經中央目的事業主管機關審定之藥品、醫療器材、產品或技術。
六、精準醫療：指透過基因定序、分子鑑定或代謝體分析等之體學檢測，分析個體之生理病理特性與疾病機制及程度之關係，以提供疾病之預測、預防、診斷及治療功能，並經主管機關會同中央目的事業主管機關審定之創新性產品或技術。
七、數位醫療：指以巨量資料、雲端運算、物聯網、人工智慧、機器學習技術應用於健康醫療照護領域，且用於提升疾病之預防、診斷及治療，並經主管機關會同中央目的事業主管機關審定之創新性產品或技術。
但屬人工智慧或機器學習技術之醫療器材軟體，由中央目的事業主管機關審定。
八、專用於生技醫藥產業之創新技術平台：指專門應用於第三款或第五款之研發製造，或提供第二款第二目之開發製造新藥、新劑型製劑或再生醫療，並經主管機關會同中央目的事業主管機關及財政部審定之具高度研發風險、關鍵性及創新性產品或技術之平台。
九、其他策略生技醫藥產品：指經行政院指定為具策略性發展方向之生技醫藥項目，並經主管機關審定後公告者。
前項第二款生技醫藥公司之審定要件、應備文件、程序、審定之撤銷或廢止及其他相關事項之辦法，由主管機關定之。