2015-01-012024-05-17https://scholars.lib.ntu.edu.tw/handle/123456789/682501摘要：傳統中醫與中獸醫雖然有悠久的歷史，除中國大陸的中獸藥外，國內外對於中藥於獸醫畜牧之應用，尚無核發中草藥之動物用藥品許可證。然而，草本養殖和當前中獸醫對傳統中藥的應用與日俱增，對於動物用傳統中藥之安全性評估與檢驗登記，相關管理制度有待建立。本計畫針對動物用傳統中藥之檢驗登記管理，蒐集國內外相關法規，進行法制探討。參考歐美與國內人用中藥管理傳統故有成方之法規，並審酌當前動物用中藥之需求與趨勢，研擬適合我國施行之動物用傳統中藥檢驗登記管理構想建議草案，並經專家委員會之審議，提出共識版本之管理建議草案，提供主管機關參考，協助健全我國動物用藥品之管理法規與制度。<br> Abstract: Although the use of traditional Chinese medicines (TCM) in both human and veterinary medicine has a very long history, no marketing registration of TCM as veterinary drugs has been approved in Taiwan and many other countries, except for mainland China. However, The application of herbal drugs as veterinary drugs for medical purposes is growing rapidly. Hence, regulatory measures and registration requirements for new and traditional herbal veterinary drugs should be established. This project aims to collect regulations implemented by other countries to guide the evaluation and registration requirements for botanical and Chinese herbal drugs. A detailed analysis on the current regulatory strategy of botanical/herbal medicinal products for human use in Taiwan and other countries will be performed. A draft proposal to regulate veterinary TCM will be proposed in considering the current trend and need in Taiwan. The proposal will be reviewed and discussed by an expert committee that is comprised of experts in the field of veterinary drugs and herbal medicines. A consensus draft of the proposal will be submitted to the regulatory authority BAPHIQ. The final goal of this project is to facilitate the establishment of a comprehensive system to regulate veterinary medicinal products in Taiwan.動物用藥品傳統中草藥檢驗登記Veterinary DrugTraditional Chinese Herbal MedicineMarketing Registration