2019-01-012024-05-17https://scholars.lib.ntu.edu.tw/handle/123456789/682447摘要：本計畫主旨在研提我國動物用診斷試劑檢驗登記應檢附文件及技術資料建議草案，藉由彙整美國與加拿大二國管理動物用診斷試劑之規定，包含檢驗登記應檢附資料，以及對診斷試劑品質、效能與安定性等技術資料之要求，研提我國動物用診斷試劑檢驗登記應檢附文件及技術資料建議草案，提供主管機關參考，以利未來我國管理動物用診斷試劑檢驗登記之需求，協助健全我國管理包含診斷試劑在內動物用藥品之法規環境，技術資料之規定亦提供國內與動物用診斷試劑相關生技業者產品開發之參考。 在生物技術產業快速發展的基礎上，生物製品產業已成為全球生物技術產業（包括獸醫產品）發展的重要趨勢。為了協助動物藥品生產企業的研發階段進入國際市場。並且該產品可以快速獲得註冊和產品許可。因此，我們需要關注獸藥的監管信息，包括檢查，質量控制，藥物警戒，醫藥信息，管理，檢查，登記等。此外，我們還必須了解國際規範和標準。通過研究和分析國際獸藥產品註冊技術要求協調組織（VICH）制定的指南，這些指南將有助於加強台灣獸藥管理的整體監管框架。基於這些原因，該項目旨在收集VICH GL17-“新生物技術/生物獸醫醫療產品的穩定性測試”。通過研究和分析VICH GL17，將起草動物生物技術/生物製品穩定性測試指南，討論穩定性測試的指導草案和基本原則。此外，還將舉辦4場研討會，向研發人員宣傳動物疫苗的要求和註冊程序，以加快動物疫苗的開發。<br> Abstract: The objective of this project is to propose a guidance draft for the regulations governing the registration of veterinary diagnostic kits in Taiwan. By means of studying and analyzing the overall regulatory framework and requirements for registering veterinary diagnostic kits in the United States and Canada, a guidance for registration of diagnostic kits will be drafted. The guidance draft will cover a comprehensive list of information required for registration of diagnostic kits, including general and technical requirements, such as quality, performance, stability, etc. Upon adaptation by the central government authority, the guidance will be beneficial to strengthen the overall regulatory framework for registering veterinary drugs with diagnostic kits included in Taiwan, and provide technical guidance to the domestic biotech-related sectors for the development of commercial veterinary diagnostic kits. Based on the rapid development of the biotechnology industry, biological products industry have already become important trends in the development of the global biotech industry (including veterinary medical products). In order to assist in the research and development stage of the products of animal drug manufacturers to enter the international market. And the product can quickly obtain the registration and the product license. Therefore, we need to concern the regulatory information about veterinary medicines including inspection, quality control, harmacovigilance, medicine information, management, examination,registration, etc.Further, we also have to understand the international norms and standards. By the way of studying and analyzing the guidelines that have been developed by the International Cooperation on armonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), these guidelines will be beneficial to strengthen the overall regulatory framework for managing veterinary medicines in Taiwan. According to these reasons, this project will aims at the collection of VICH GL17-「Stability testing of new biotechnological/biological veterinary medical products」. By studying and analyzing the VICH GL17, a guidance for stability testing of biotechnological/biological products for animals will be drafted. We will also provide the draft guidance and essential principles of the stability testing on the final report. Furthermore, 4 seminars will be held for propagating the requirement and registration process of animal vaccine to R &D personnel to accelerate the development of animal vaccines.動物用診斷試劑法規研析檢驗登記動物用藥品檢定標準veterinary diagnostic kitregistrationregulatory studytest standards