2018-01-012024-05-15https://scholars.lib.ntu.edu.tw/handle/123456789/663394摘要：本計畫主旨在研析動物用診斷試劑審查基準及相關準則，經由研析國際組織與先進國家管理動物用診斷試劑檢驗登記之審查基準與法規架構，研擬適合我國採行之診斷試劑檢驗登記審查基準草案或管理建議草案，提供主管機關參考，協助健全我國動物用生物藥品檢驗登記之法規環境。動物用死毒疫苗於檢驗登記時，須提供細胞培養、純度、安全試驗、活性測試及甲醛含量等相關資料，本年度將研析先進國家不活化試驗基準，並提出研析報告。國內現行動物用藥品管理制度，依據動物用藥品管理法，由中央主管機關制定相關檢驗登記事項，並陸續公告相關之作業須知，以規範檢驗登記之審查標準與各項作業規定。生物科技醫藥產品主要應用於產食動物上，與民眾身體健康及飲食安全息息相關，近年來隨著生物技術之快速發展，我國動物用疫苗研發亦發展迅速，許多新型動物用疫苗也開始進入產品登記階段，本年度將辦理4場研討會，由動物疫苗檢驗登記主辦人員向研發人員說明研發階段須注意事項，以加速我國動物疫苗研發到上市期程。本計畫也將進行動物用疫苗專題研究、產業動態分析與產值推估，包含（1）國內動物用疫苗市場分析與規模推估；（2）國內動物用疫苗產值推估；（3）國際動物用疫苗產業動態分析；（4）動物用疫苗重大議題研討。<br> Abstract: The objective of this project is to study the regulations governing the registration of veterinary diagnostic reagents and kits. By means of studying and analyzing the overall regulatory framework and requirements for registering veterinary diagnostic kits by international authorities, a draft guideline suitable for implementation in Taiwan will be proposed, which may be adopted by the authority. Upon implementation, the proposed draft may be beneficial to strengthen the regulatory framework forregistering veterinary diagnostic kits in provide cell culture requirements, purity tests, safety tests, viricidal activity test, formaldehyde content. This year, we will analysis of theanimal inactivated bacterial products and killed virus vaccines, andconduct an assessment report. Animal drug management system is accordingto Veterinary Drugs Control Act and the authority registration approvedby BAPHIQ of COA. Biotech pharmaceutical industry products are mainlyused in food animal, and regarding the public`s health and dietarysafety. In recent years, biotechnology developed rapidly in Taiwan, and with the development ofanimal vaccines, many new applications have begunto be an animal vaccine. We will have 4 seminars to propagate the requirement and registration process of animal vaccine to R &D personnel to accelerate the development of animal vaccines. This project is including as follows,(1) assessing of the production value of animal vaccines; (2) dynamic analyzing of animal vaccines industry; (3) assessing of the domestic market size ; (4) animal vaccines on major issues related to information collection.動物用診斷試劑法規研析檢驗登記veterinary diagnostic kitregulatory studyregistration