2011-01-012024-05-15https://scholars.lib.ntu.edu.tw/handle/123456789/663680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計，經許可後方能上市，國內目前並無先進國家實施已久之自家疫苗的規定。再者，廠商申請檢驗登記所提送之技術資料，並無一定的格式，而資料內容又經常是極為龐大，致使審查不易，亟需將其格式化，依固定項目分類檢附送審之資料，利於廠商申請檢驗登記時參考，以及主管機關之審查，達到便民與提升動物用藥品檢驗登記審查之效率。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，本年度將辦理8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 Act and the authority registration approved by BAPHIQ of COA. Before marketing, all animal vaccines are required to be tested and registration. But the Act is not perfect, for example, we lack the regulation of production and registration of own vaccine. And the submission form of manufacture and technology archives are not consistent format, we have to provide a template for manufacturers. 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 astandard 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 8 seminars to propagate the requirement and registration process of animal vaccine.動物用藥品檢驗登記法規研究veterinary drugregistrationregulatory study