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標題: 動物用消毒劑及相關動物用藥品檢驗登記制度研析
Study of the Regulation of Veterinary Drugs and Disinfectants
作者: 周濟眾
關鍵字: 應用研究;Disinfectant;畜牧獸醫類, 藥學;消毒劑;管理制度;動物用;Regulation;Veterinary Use
國內主管機關,尤其動物用藥品技術審議委員會在審議核准動物用消毒劑產品進口或上市過程中,常遇到因進口國不同而有申請資料及標準無法一致之情形。申請人亦無可遵循之一標準而無法一次提出完整之必備資料,導致申請者以及主管機關共同之困擾。核准結果也容易引起各方討論。因此本計畫將有助於對各國動物用消毒劑管理制度之全面性瞭解。本計畫擬收集並比較歐、美、日先進國家動物用消毒劑的檢驗及登記制度及製造廠之管理規範,並參考中國大陸之作法,研擬出最適合本國國情之動物用消毒劑檢驗及登記制度,以玆本國動物用消毒劑之核准及製造廠之管理參考。實施方式為依主管機關之網頁先進行資料收集:美國為環境保護署(EPA)及食品藥物管理局(FDA),英國為環境食品農事部(Defra)的獸醫實驗室機構(VLA),日本為農林水產省動物醫藥品檢查所,歐盟為ANNEX8: BiocidalProduct Directive 98/8/EC,中國為農業部獸藥管理條例所制訂的獸藥註冊辦法。先全面瀏覽收集內容,就重要工作項目內容予以整理,比較,然後列表翻譯重要工作項目之重點內容。列表比較各國之異同並與本計畫共同主持人、計畫承辦人及其他相關計畫主持人定期討論重要工作項目內容及交換研擬草案要領及心得研擬適合本國之草案。本計畫知完成將對各國動物用消毒劑產品之主管機關、檢驗項目及方法、登記制度及各經濟區對於動物用消毒劑製造廠之管理規範等,有更深入的認識,可供我國參考對相關產品之管理提供一致性之規範,強化管理依據。此外,有關單位在針對其他動物用藥品之申請檢驗及登記時,也常遇到與消毒劑相似的情況,因此有必要一併予以檢討。因此,為因應輸入製造動物用藥品業界之實際需要,擬研究如何提升動物用藥品檢驗登記審查制度之行政效率、技術資料審查之精確度及相關檢驗登記程序之完整性, 對現階段動物用藥品檢驗登記流程之影響進行研析並提出建議,以 與國際規範接軌,俾利作為我國未來動物用藥品檢驗登記政策之參考。

The regulatory agency for veterinary drugs in Taiwan usually encounters situations in which applications for approval of new drugs from different countries and regions present different requirements for documentation. As such the administrator is often bothered by inconsistency in the application procedure and paper work or be questioned with the lack of universal standards. Therefore, the purpose of this study is to collect and evaluate the regulatory issues and requirements for new veterinary disinfectants application in major countries (including China, Japan, the United States, European union and England) and to evaluate the pro and cons for the application and regulation systems in each country in order to establish a refined system/requirement most suitable for use in Taiwan. The study will be carried out first by information collection from representative governmental websites, followed by translation of critical information and comparison among various countries. Experts from other universities in charge of similar projects concerning different veterinary products will join a group discussion session to draft the initial regulatory rules for a pannel to further review. The completion of this study will benefit the government with a uniformed regulation for new disinfectant application in Taiwan and reduce unnecessary costs and time for both the manufacture and the administrator. In addition, in view of the fact that other veterinary drugs, when applying for new approval, may encounter similar situation as suggested for new disinfectant application, the current study will also include a pannel (member of 3 ) review for the documents submitted to the administrator to discuss for an uniformed set of requirements for all future applications. The whole project, when successfully completed, will be the blueprint for a more complete and clear policy governing the regulation of new veterinary drugs applications.
其他識別: 98農科-9.2.2-檢-B2(4)
Appears in Collections:獸醫學系所

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