2015-01-012024-05-15https://scholars.lib.ntu.edu.tw/handle/123456789/662546摘要：近幾年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，檢驗登記相關法規如何與國際規範接軌，已成為主管機關重要議題。本年度將研析VICH動物用藥品安定性試驗基準，辦理專家會議，討論審查試驗基準草案。並蒐集研析先進國家管理單價疫苗組合成多價疫苗之效力評估規範，提出研析報告。為使研發人員對於動物疫苗登記時，能夠了解即將進行之試驗種類、生產文件與試驗規格，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。<br> Abstract: In recent years, due to the rapid development of animal vaccines and biotechnology in Taiwan, many new applications for registrating animal vaccines have been submitted to the regulatory authority. The objectives of this year project is to discuss and analyze the VICH guideline "Testing of new veterinary drug substances ans medicinal products" and to propose a draft of Chinese version of the guideline, and to call expert meetings to review the draft. The project will also collect effecacy assessment specifications for multivalent vaccines that are manufactured by combining monovalent vaccines. The project will have 4 seminars to explain the requirement and registration process for animal vaccine registration to reseachers to accelerate the development of animal vaccines in Taiwan.動物用疫苗動物用藥品檢驗標準登記Veterinary VaccineTest Standards for Veterinary DrugsRegistration