2012-02-232024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/661621摘要：我國現行動物用藥品管理制度，依據動物用藥品管理法，有關檢驗登記事項，由中央主管機關定之，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，雖然運作大致順暢，仍有少數幾項規範尚未臻周延，例如動物用生物藥品 皆須進行完整的檢驗登記，經許可後方能上市。生物相似性藥品指以生物技術衍生 之生物藥品，於品質、安全及功效上，與作為&#63851;考之原開發生物藥品相似。有關這類藥品檢驗登記之管理，歐美日與我國衛生機關已有相關之藥品管理規範。因應當 前生技趨勢，動物用相似性藥品之管理規範急需建立。目前動物用藥品檢驗標準及 新藥試驗動物試驗方法，皆依循過去累積之經驗所研擬，但因擬訂時程與擬訂人員各異，內容與用語仍未達完全一致性之作法，及需加以整理，並訂定一套足供依循 之訂定方式。並討論動物用藥品檢驗方法內容，提出修改優先順序。近年動物疫苗 產業整併與新市場開發並進，產業趨勢需要進一步了解。本計畫將對上述工作進行研析，並提出草案與建議。此外，為了讓學界與產業界更加了解我國動物疫苗產品 登記制度與程序，本年度將持續辦理4場說明會，直接面對面介紹與回答疫苗研究人員與業者之需求。<br> Abstract: Animal drug management system is according to Veterinary Drugs Control marketing, all animal vaccines are required to be tested and registration. The biosimilar drugs refer to biologicals of by the biological technology derivation with similar quality safety and efficacy compared with original biologicals. Concerns management of animal biosimilar drugs examination registration, the European country, Japan, United State of America and Department of Health had conducted mangement process and related. Regarding the trend of biological technology progress, the regulations of animal biosimilar drugs urgently needed establishment. All testing in “Test Standards for Veterinary Drugs” is conducted by experts in a long period. The terms and format are not consistent. We have to set up a standard operation procedure for construction of “Test Standards for Veterinary Drugs”. The researcher and manufacture have not enough message of regulation and requirement of registration of animal vaccine. In this project, we will have 4 seminars to propagate the requirement and registration process of animal vaccine.動物疫苗動物用藥品檢驗標準登記animal vaccineTest Standards for Veterinary Drugsrigistration