| 期刊全稱 | Approaching China‘s Pharmaceutical Market | | 期刊簡(jiǎn)稱 | A Fundamental Guide | | 影響因子2023 | Ming Q. Lu | | 視頻video | http://file.papertrans.cn/161/160337/160337.mp4 | | 發(fā)行地址 | Addresses the key issues for multinational pharmaceutical companies looking to market their drugs in China.Highlights the regulations of the Chinese State Food and Drug Administration (SFDA) and the C | | 圖書(shū)封面 |  | | 影響因子 | ?This authoritative volume examines the major laws, regulations and guidelines related to pharmaceutical product development in China. With a focus on patent, clinical and registration strategies, the book helps Western companies introduce their clinical drugs to the Chinese market, determine a strategic path and bridge the gap for regulatory and legal differences between China and the Western world. For a better understanding of the drug registration process, it explores the differences between the China Food and Drug Administration (CFDA)—including its regulations and registration procedures—and those of the Western world. The volume discusses disparities between China‘s application requirements compared to Western standards to make it easier for companies to prepare their application packages. It also provides detailed commentary on CFDA guidelines in reference to clinical trial (IND) and market application (NDA) requirements. ? Overall, this book offers guidance for Western companies aspiring to expand into China’s pharmaceutical market in hopes that they may gain a fundamental understanding of its rules and complexities in order to ensure a smooth transition and prevent future | | Pindex | Book 2015 |
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