2023-09-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/660633盤點國內動物用藥及農藥登記制度、審查流程及管理法規內容。 蒐集研析國內外人用藥品、動物用藥品和環境用藥等之登記審查規範，滾動檢討我國現行管理動物用藥品檢驗登記相關規範，提出精進措施建議。此外，因應動物用藥品產業需求，針對口服散劑之賦形劑，進行管理規範之法規科學研究，研擬合適之賦形劑變更登記之管理規範，陳主管機關施政參考。 1. 因應我國動物用藥品檢驗登記之管理需求，進行國內外藥品登記之法規研究，蒐集、彙整與研析國內外動物用藥品、人用藥品和環境用藥等的登記審查規範，滾動檢討我國現行動物用藥品檢驗登記之法規制度，研提符合國際間管理趨勢及產業需求之精進措施。計畫成果有助於因應動物用藥品之管理趨勢，健全國內管理動物用藥品法規與檢驗登記規範，促使國內動物用藥品法規的完備。 2. 提供主管機關農藥登記審查規範與國內管理做法資料。 Take stock of the domestic animal drug and pesticide registration system, review process, and management regulations. Collect and analyze domestic and foreign registration review standards for human drugs, animal drugs, and environmental drugs, continuously review my country`s current regulations related to the inspection and registration of animal drugs, and suggest improvement measures. In addition, in response to the needs of the animal drug industry, we conduct regulatory research on the management of excipients for oral powders, and develop appropriate management standards for excipient change registration, which will serve as a reference for the competent authorities in their policies. 1. In response to the management needs of animal drug inspection and registration, conduct research on domestic and foreign drug registration regulations, collect, compile, and analyze domestic and foreign registration review standards for animal drugs, human drugs, and environmental drugs, and conduct a rolling review of the current laws and regulations for the inspection and registration of animal drugs will be developed to develop advanced measures that are in line with international management trends and industry needs. The project`s results will help respond to the management trend of animal drugs, improve the domestic regulations and inspection and registration standards for the management of animal drugs, and promote the completion of domestic animal drugs regulations. 2. Provide information on pesticide registration review specifications and domestic management practices of the competent authorities.動物用藥品檢驗登記;農藥;法規研究;veterinary drug;pesticide;regulatory study