2013-01-282024-05-15https://scholars.lib.ntu.edu.tw/handle/123456789/662881摘要：蒐集國際組織和先進國家動物用藥品新藥進行臨床研究之規範，和我國現行動物用藥品新藥試驗辦法進行法規研析和比較，針對動物用藥品新藥如新興抗癌藥物，研擬其臨床試驗與檢驗登記之規範草案，籌組包含法律顧問之專家委員會，完成研提草案之審議和研提。本計畫工作項目包括：(1)因應管理新興動物用藥品臨床研究與檢驗登記之需求，研提動物用藥品新藥試驗規範建議草案，以適切因應當前動物用藥品之管理趨勢，健全我國動物用藥品管理法規。(2)針對受關注之動物用藥品議題，進行文獻資料探討，提出科學評析報告和管理建議供參。(3)藉由實質參與，培養國內未來動物用藥品法規人力。<br> Abstract: Collect international regulations and requirements for the new drug clinical investigation of veterinary medicinal products, and compare to the current regulations applied domestically. Propose draft guidelines or rules to regulate the conduct of clinical study for registration of new animal drugs, such as anti-cancer agents for pet animals. The proposed drafts will be reviewed, discussed and finalized by an established committee whose members include experts major in the fields of veterinary drugs and veterinary regulations. Specific aims of this project include:(1)In response to the need to regulate clinical and/or field research for registration of new animal drugs, the project will propose draft guidelines or rules that can be applied to meet the current trend and need for regulating the registration of new drugs, and strengthen the overall structure of the regulatory network for animal drugs in Taiwan. (2) Collect and study information relevant to emerging critical issues on animal drugs. Comprehensive reports and suggestions pertaining to the issues will be available for the authority.(3)Trainees recruited to this project will participate in the regulatory review and study, and therefore may gain their competency in the field of regulatory science on veterinary drugs.動物用藥品檢驗登記新藥試驗法規veterinary drugregistrationnew drug investigationregulation