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

丁宇星(Ding Yu-Xing)

指導教授 ： 冷則剛

國立政治大學/商學院/國際經營管理英語碩士學位學程(IMBA)/碩士(2018年)

https://doi.org/10.6814/THE.NCCU.IMBA.041.2018.F08

摘要

本論文以英文書寫，作者無提供中文摘要。

關鍵字

動物保健 ； 規制策略 ； 動物藥品 ； 中國

並列摘要

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.

並列關鍵字

Animal health ； Regulatory strategy ； Veterinary medicinal product ； China

參考文獻

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