政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/121731

政大機構典藏-National Chengchi University Institutional Repository(NCCUR):Item 140.119/121731

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政大機構典藏 > 商學院 > 國際經營管理英語碩士學程IMBA > 學位論文 > Item 140.119/121731

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題名:	形塑動物保健行業在各國的藥品註冊策略 : 以中國為例 Shaping Regulatory Affairs Strategy in Animal Healthcare Industry at a Country Level: The Case of China
作者:	丁宇星 Ding, Yu-Xing
貢獻者:	冷則剛 Leng, Tse-Kang 丁宇星 Ding, Yu-Xing
關鍵詞:	動物保健規制策略動物藥品中國 Animal health Regulatory strategy Veterinary medicinal product China
日期:	2018
上傳時間:	2019-01-04 16:20:15 (UTC+8)
摘要:	The fast-growing global demand for livestock-derived products and pet health care has driven the animal healthcare industry to develop safe, efficacious, and high-quality veterinary medicinal products. The commercialization of most veterinary medicinal products, similar to human medicine, requires the marketing authorization from regulatory authorities. However, the complexities of regulatory environment and inconsistent regulatory requirement at different markets have still been a hurdle for multinational companies to rapidly bring new products to the market, especially to China. The objective of this study is to provide a systemic analysis on China’s regulatory landscape as well as to help animal healthcare firms develop a well-structured and robust in-country regulatory affairs strategy in China.We started from examining existing regulatory challenges and conducting gap analysis on currently proposed solutions to regulators and industry. The roadmap comprising key driving forces and elements to the regulatory approval in China as well as potential roadblocks were analyzed and constructed. The proposed “Schematic of Regulatory Affairs Process” offers a practical approach for multinational animal healthcare firms to develop the most rewarding regulatory affairs strategy in China via capturing required forces driving to the regulatory approval of veterinary medicinal product.
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描述:	碩士國立政治大學國際經營管理英語碩士學位學程(IMBA) 104933004
資料來源:	http://thesis.lib.nccu.edu.tw/record/#G0104933004
資料類型:	thesis
DOI:	10.6814/THE.NCCU.IMBA.041.2018.F08
顯示於類別:	[國際經營管理英語碩士學程IMBA] 學位論文

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The digital content of this website is part of National Chengchi University Institutional Repository. It provides free access to academic research and public education for non-commercial use. Please utilize it in a proper and reasonable manner and respect the rights of copyright owners. For commercial use, please obtain authorization from the copyright owner in advance.

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NCCU Institutional Repository is made to protect the interests of copyright owners. If you believe that any material on the website infringes copyright, please contact our staff(nccur@nccu.edu.tw). We will remove the work from the repository and investigate your claim.

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