2016-01-012024-05-17https://scholars.lib.ntu.edu.tw/handle/123456789/682428摘要：目前動物用藥品檢驗標準及新藥試驗動物試驗方法，有些仍與其他國家有所差異，急需比對後訂定一致性之方法以與各國標準接軌。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，但目前我國動物疫苗產業急速發展，需要對國際規範進行研究與了解，本計畫將研析VICH規範中有關黴漿菌污染檢測基準，並收集先進國家之動物用藥品不良反應通報資訊，提出研析建議；另規劃我國動物用藥品檢驗登記之毒理安全性試驗GLP制度研析，規劃我國動物用藥品GLP之推動方式建議草案。本計畫也將進行國際動物用疫苗產業動態分析、國內動物用疫苗市場分析與規模推估及國內動物用疫苗產值推估。<br> Abstract: Currently animal drug testing standards and test methods for new drugs in experimental animals, and some still have differences with other countries, the consistency of the method compared to the urgent need to set in order and national standards. 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. Concerns management, examination and registration of protein drugs for animal use, we have to analysis the mangement process and related. The researcher and manufacture have not enough information of regulation and requirement of registration of animal vaccine, we need understanding of international norms and standards. This project will study analyzes VICH testing for the detection of mycoplasma contamination, and also collect international veteriinary regulation and pharmacovigilance information. Furthermore, analysis of animal drug testing GLP toxicological safety tests system registration, and planning of animal medicines GLP way of promoting draft recommendation. This project will also mainly focus on dynamic analyzing of animal vaccines industry, and assessing of the domestic market size and the production value of animal vaccines.動物用疫苗黴漿菌動物用藥品不良反應產值市場規模Veterinary vaccineMycoplasmaPharmacovigilanceproduction valuemarket size