Regulations Governing Incentive Rewards for Research and Development of Pharmaceutical Technology Article 4
The qualifications for incentive rewards under these Regulations are as follows:1. Having independently developed in Taiwan a newly invented pharmaceutical for which a patent has been obtained in Taiwan or abroad and which had its first market launch in Taiwan or another advanced country.2. Having obtained domestic or foreign patent licensing for a newly invented pharmaceutical that was developed in Taiwan, and the product that is produced received its first approval or market launch in Taiwan or another advanced country.3. Having obtained a patent or patent licensing in Taiwan or abroad for a pharmaceutical developed in Taiwan but not yet launched on the market and that has been approved for clinical trials in Taiwan or abroad and has shown concrete efficacy. (Respective applications for incentive rewards may be submitted for each of phases I, II, and III of human clinical trials.)4. Having developed or manufactured a pharmaceutical in Taiwan that has shown important and concrete performance in the market.5. Having developed or manufactured a pharmaceutical in Taiwan that has been patented in Taiwan or abroad as an improvement over prior art and that has made a concrete contribution to the development of the pharmaceutical manufacturing industry.6. Having developed or manufactured a new active pharmaceutical ingredient, excipient, medical device material, or part or component in Taiwan that has made a significant contribution to improving the pharmaceutical manufacturing industry in Taiwan.7. Having introduced advanced technology from abroad, which, in the area of research and manufacture of biopharmaceuticals, has made a significant contribution to medical treatment of illnesses in Taiwan.8. Having independently developed new equipment or devices, manufacturing processes, or analytical and testing methods in Taiwan which have had a major effect in improving pharmaceutical manufacturing or testing techniques.9. Having shown outstanding performance in promoting development of the pharmaceutical manufacturing industry in Taiwan in cooperation with the policies of the central competent authorities for health or industry, to raise the standards of medicament research and development.
中文原文 藥物科技研究發展獎勵辦法第4條
本辦法適用之獎勵條件如下：
一、國內自行研發，取得國內（外）專利，在我國或其他先進國家首先上市之新發明藥物者。
二、取得國內（外）專利之授權，在國內研發，所生產製品為我國或其他先進國家首先核准或上市之新發明藥物者。
三、國內研發之未上市藥物，取得國內（外）專利或授權，且經核准在國內（外）進行臨床試驗研究，有具體成效者。
（人體試驗階段一、階段二或階段三，各階段得分別提出申請獎勵）四、國內研發或製造藥物，有重要且具體之市場成效者。
五、國內研發或製造藥物以進步性，取得國內外專利，且對藥物製造工業發展有具體貢獻者。
六、國內研發或製造之新原料藥、賦形劑、醫療器材材質、零組件，對提昇我國藥物製造工業有顯著貢獻者。
七、引進國外先進科技，於國內研究並產製生物製劑藥品，對國人疾病之醫療有顯著貢獻者。
八、國內自行開發新設備裝置、製程或分析檢驗方法，對改進藥物製造或檢驗技術有重大成效者。
九、配合中央衛生或工業主管機關政策，推動本國藥物製造工業發展，提昇藥物研發水準，績效卓著者。
一、國內自行研發，取得國內（外）專利，在我國或其他先進國家首先上市之新發明藥物者。
二、取得國內（外）專利之授權，在國內研發，所生產製品為我國或其他先進國家首先核准或上市之新發明藥物者。
三、國內研發之未上市藥物，取得國內（外）專利或授權，且經核准在國內（外）進行臨床試驗研究，有具體成效者。
（人體試驗階段一、階段二或階段三，各階段得分別提出申請獎勵）四、國內研發或製造藥物，有重要且具體之市場成效者。
五、國內研發或製造藥物以進步性，取得國內外專利，且對藥物製造工業發展有具體貢獻者。
六、國內研發或製造之新原料藥、賦形劑、醫療器材材質、零組件，對提昇我國藥物製造工業有顯著貢獻者。
七、引進國外先進科技，於國內研究並產製生物製劑藥品，對國人疾病之醫療有顯著貢獻者。
八、國內自行開發新設備裝置、製程或分析檢驗方法，對改進藥物製造或檢驗技術有重大成效者。
九、配合中央衛生或工業主管機關政策，推動本國藥物製造工業發展，提昇藥物研發水準，績效卓著者。