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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 4-一月-2019 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. 參考文獻 [1] Hunter, R. P., Shryock, T. R., Cox, B. R., Butler, R. R., Hammelman, J. E. [J]. Overview of the animal health drug development and registration process: an industry perspective. 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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 dc.contributor.advisor 冷則剛 zh_TW dc.contributor.advisor Leng, Tse-Kang en_US dc.contributor.author (作者) 丁宇星 zh_TW dc.contributor.author (作者) Ding, Yu-Xing en_US dc.creator (作者) 丁宇星 zh_TW dc.creator (作者) Ding, Yu-Xing en_US dc.date (日期) 2018 en_US dc.date.accessioned 4-一月-2019 16:20:15 (UTC+8) - dc.date.available 4-一月-2019 16:20:15 (UTC+8) - dc.date.issued (上傳時間) 4-一月-2019 16:20:15 (UTC+8) - dc.identifier (其他 識別碼) G0104933004 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/121731 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 國際經營管理英語碩士學位學程(IMBA) zh_TW dc.description (描述) 104933004 zh_TW dc.description.abstract (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. en_US dc.description.tableofcontents 1. Introduction ......12. Review.....42.1. Overview of Animal Healthcare (AH) Industry ....42.2. Regulatory Landscape for Animal Healthcare Product ....82.2.1. Regulatory Body and Regulatory Framework....92.2.2. Key Animal Healthcare Stakeholder ......142.2.3. Registration Process and Timeline ......172.2.4. Regulatory Requirement and Assessment Approach ....222.3. Regulatory Challenge and Impact on Animal Healthcare Products .....262.3.1. at a Global Level .......262.3.2. at a Regional Level .......292.3.3. at a Country Level .......342.4. China Focus ......393. Gap Analysis ........423.1. on Proposed Solutions to Regulatory Challenges for Regulators ..........433.2. on Proposed Solutions to Regulatory Challenges for AH Industry ......464. Proposed Solution ........49iv4.1. Roadmap to Regulatory Approval in China .....504.2. Roadblocks to Regulatory Approval in China .....524.3. “Schematic of Regulatory Affairs Process” to Regulatory Approval........574.3.1. Regulatory Landscape Analysis .......574.3.2. Creating Forces to Regulatory Approval .....624.3.3. Capturing Forces to Regulatory Approval ......644.3.4. Sustaining Forces to Regulatory Approval ......685. Conclusion .....696. Reference ......73 zh_TW dc.format.extent 7341184 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0104933004 en_US dc.subject (關鍵詞) 動物保健 zh_TW dc.subject (關鍵詞) 規制策略 zh_TW dc.subject (關鍵詞) 動物藥品 zh_TW dc.subject (關鍵詞) 中國 zh_TW dc.subject (關鍵詞) Animal health en_US dc.subject (關鍵詞) Regulatory strategy en_US dc.subject (關鍵詞) Veterinary medicinal product en_US dc.subject (關鍵詞) China en_US dc.title (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 zh_TW dc.title (題名) Shaping Regulatory Affairs Strategy in Animal Healthcare Industry at a Country Level: The Case of China en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) [1] Hunter, R. P., Shryock, T. R., Cox, B. R., Butler, R. R., Hammelman, J. E. [J]. Overview of the animal health drug development and registration process: an industry perspective. Future Med. Chem., 2011, 3(7): 881-886.[2] AnimalHealthEurope. 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