2017-01-012024-05-17https://scholars.lib.ntu.edu.tw/handle/123456789/682406摘要：我國動物用藥品檢驗登記，依據動物用藥品管理法第12條規定，應向中央主管機關申請檢驗登記，經核准發給許可證後，始得製造或輸入。為審議新藥檢驗登記，依動物用藥品管理法施行細則第4條，設置動物用藥品技術審議委員會（以下簡稱技審會），針對動物用藥品申請案件之審議事項、檢驗規格、使用基準、新藥試驗等之審訂事項與其他有關動物用藥品技術改進之諮詢審議及調查事項加以討論與決議。因應動植物防疫檢疫局工作內容調整，擬將動物疫苗之新藥審查作業，移轉到財團法人農業科技研究院接辦，其完成初步審查後之審查意見報告，陳送動植物防疫檢疫局與技術審議委員會審議。本計畫將持續辦理動物用藥品審查，全年預計辦理240件次，協助辦理4-6次技術審議委員會。評估國際間含中草藥或天然植物藥用成分使用於動物之管理法規研究，以本國常見之疑義案件擬定相關的管理基準與建議成分清單，期能適切因應本國動物用藥品管理趨勢，針對具潛在風險之動物用藥品議題，研析科學文獻新知與國際管理規範，研提評析報告和風險管理建議，經專家會議討論，提供主管機關對重要風險議題之因應與管理策略之參考。<br> Abstract: Study on Animal Drug Registration Regulations and Risk AssessmentAccording to Veterinary Drug Control Act Article 12, one shall apply tothe central competent authority for product registration to manufacture or import the drugs. According to Enforcement Rules of Veterinary Drugs Control Act Article 4, the central competent authority shall invite the experts and scholars to set the Technical Committee with Veterinary drugs in order to review the veterinary drug in accordance with the provision of the Act. The committee reviewed the case of the contents of the veterinary drug applications, test specifications, use, field trials and veterinary drug advisory technical improvements. Due to BAPHIQ adjust the contents of the work, the work of veterinary drugs review will be transferred to the Foundation, which complete the preliminary evaluation report, and submit to BAPHIQ and committee reviewed. The program will continue to handle primary review of veterinary medicine, is expected to handle 240 cases throughout the year, and will help to run 4-6 the Technical Review Committees. Evaluate the global regulations that govern the use of herbal medicinal and natural ingredients in animals. In case that high risk issues associated with the use of herbal and natural products in animals emerge in Taiwan, the risk related to this kind of cases will be thoroughly studied to assess its potential hazardous constituents. Scientific evidence in the literature and the regulatory framework imposed by other countries will be the primary information to be studied and compared. Assessment reports addressing the risk of potential hazardous constituents contained in the concerned herbal and natural products will be discussed by an expert study panel and then submitted to the authority for potential implementation.動物用藥品檢驗登記風險評估法規研究animal drugregistrationrisk assessmentregulatory study