2016-01-012024-05-17https://scholars.lib.ntu.edu.tw/handle/123456789/682277摘要：動物用活毒疫苗於檢驗登記時須提供對象動物安全性測試，本年度將研析先進國家動物用疫苗毒力回歸試驗基準，並提出研析報告。於現行國內之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，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，近年來我國動物用疫苗之研發發展迅速，並隨著生物技術之發展，許多應用新式動物疫苗也開始進入產品登記階段，本年度將辦理4場說明會，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。因應我國動物用藥品管理需求，針對世界各國動物用藥品的查驗登記管理法規、製造動物用藥品之規範、和藥品品質檢驗基準，進行全面性的法規分析。參考先進國家動物用藥品法規制度，並審酌國內動物用和人用藥品之管理規範，研擬適合我國施行之動物用藥品科技政策和管理基準草案。<br> Abstract: Animals live vaccine at the time of inspection and registration are required to provide target animal safety testing. This year, we will analysis of the animal vaccines reverse virulence technology and conduct an assessment report. Animal drug management system is according to Veterinary Drugs Control Act and the authority registration approved by BAPHIQ of COA. Before marketing, all animal vaccines are required to be tested and registration. In recent years, animal vaccines developed rapidly in Taiwan, and with the development of biotechnology , many new applications have begun to be an animal vaccine. To enable researchers registration for animal vaccine, able to understand the types of the animal clinical trial, manufacture documentation and test methods, 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.To enable researchers registration for animal vaccine, able to understand the types of the animal clinical trial, manufacture documentation and test methods, 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. In response to the management needs of animal drugs, animal drugs for the world`s examine the registration regulations, manufacturers of animal regulate drug, and drug quality inspection benchmarks, we conducted a comprehensive analysis of legislation. By consult the advanced countries animal drugs laws and regulations, and the trial discretionary domestic animal management practices and medicines for human use, the elaboration of the implementation of appropriate policies and draft animal management benchmarks with drugs and Technology.動物用疫苗動物用藥品檢驗標準登記病毒毒力回歸Veterinary vaccineTest standard for Veterinary DrugsregistrationReversion to virulence