Approaching China's Pharmaceutical Market

Approaching China's Pharmaceutical Market
Author: Ming Q. Lu
Publisher: Springer
Total Pages: 657
Release: 2015-07-30
Genre: Medical
ISBN: 3319155768

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​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 issues.

Approaching a New Market

Approaching a New Market
Author: Kathleen Anne Fickle
Publisher:
Total Pages: 562
Release: 1986
Genre:
ISBN:

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Innovation, Economic Development, and Intellectual Property in India and China

Innovation, Economic Development, and Intellectual Property in India and China
Author: Kung-Chung Liu
Publisher: Springer Nature
Total Pages: 513
Release: 2019-09-06
Genre: Law
ISBN: 981138102X

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This open access book analyses intellectual property codification and innovation governance in the development of six key industries in India and China. These industries are reflective of the innovation and economic development of the two economies, or of vital importance to them: the IT Industry; the film industry; the pharmaceutical industry; plant varieties and food security; the automobile industry; and peer production and the sharing economy. The analysis extends beyond the domain of IP law, and includes economics and policy analysis. The overarching concern that cuts through all chapters is an inquiry into why certain industries have developed in one country and not in the other, including: the role that state innovation policy and/or IP policy played in such development; the nature of the state innovation policy/IP policy; and whether such policy has been causal, facilitating, crippling, co-relational, or simply irrelevant. The book asks what India and China can learn from each other, and whether there is any possibility of synergy. The book provides a real-life understanding of how IP laws interact with innovation and economic development in the six selected economic sectors in China and India. The reader can also draw lessons from the success or failure of these sectors.

The Commercialization of Pharmaceutical Patents in China

The Commercialization of Pharmaceutical Patents in China
Author: James Hou
Publisher: Edward Elgar Publishing
Total Pages: 352
Release: 2021-03-28
Genre:
ISBN: 9781789908220

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Presenting detailed analysis of the industrialization and commercialization of pharmaceutical patents in China, this timely book explores a range of related topics including a comparison of the ideal and existing state of the pharmaceutical market and patent industrialization. It argues that the core purpose of the industrialization of pharmaceutical patents is to promote the development of the local pharmaceutical industry whist also protecting society's right to safe and effective medication. Chapters examine the special application issues of patent law in relation to the field of pharmaceuticals, compare the Chinese and American legal systems and their approach to pharmaceutical patents, and provide in depth political and legal analysis of the industry. James Hou suggests methods by which the Chinese legal system can seek to improve its governance of pharmaceutical patents and balance the conflicts of interest arising between new drug developers, established drug manufacturers and the end users. Featuring comprehensive coverage of patents in the Chinese pharmaceutical industry, this book will be a key resource for scholars and students of commercial, pharmaceutical and intellectual property law, whilst also being of interest to industry talents discovering the potential of their own innovations.

China Medical and Pharmaceutical Industry Business Intelligence Report Volume 1 Strategic Information, Regulations, Contacts

China Medical and Pharmaceutical Industry Business Intelligence Report Volume 1 Strategic Information, Regulations, Contacts
Author: IBP, Inc
Publisher: Lulu.com
Total Pages: 327
Release: 2018-09-03
Genre: Business & Economics
ISBN: 1433061309

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2011 Updated Reprint. Updated Annually. China Pharmaceutical Chemicals Producers Directory

China's Healthcare System and Reform

China's Healthcare System and Reform
Author: Lawton Robert Burns
Publisher: Cambridge University Press
Total Pages: 744
Release: 2017-01-26
Genre: Business & Economics
ISBN: 1316738396

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This volume provides a comprehensive review of China's healthcare system and policy reforms in the context of the global economy. Following a value-chain framework, the 16 chapters cover the payers, the providers, and the producers (manufacturers) in China's system. It also provides a detailed analysis of the historical development of China's healthcare system, the current state of its broad reforms, and the uneasy balance between China's market-driven approach and governmental regulation. Most importantly, it devotes considerable attention to the major problems confronting China, including chronic illness, public health, and long-term care and economic security for the elderly. Burns and Liu have assembled the latest research from leading health economists and political scientists, as well as senior public health officials and corporate executives, making this book an essential read for industry professionals, policymakers, researchers, and students studying comparative health systems across the world.

The Chemical and Pharmaceutical Industry in China

The Chemical and Pharmaceutical Industry in China
Author: G. Festel
Publisher: Springer
Total Pages: 296
Release: 2009-09-02
Genre: Business & Economics
ISBN: 9783540802907

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A detailed examination of China’s increasingly important chemical and pharmaceutical industry. Numerous case studies describe how western companies, such as BASF, Bayer, Bicoll, Ciba, Degussa, DSM and Novartis are managing their market entry in China.

The Problems and Potential of China's Pharmaceutical Industry

The Problems and Potential of China's Pharmaceutical Industry
Author: Roger Bate
Publisher:
Total Pages: 0
Release: 2014
Genre:
ISBN:

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China's pharmaceutical market has experienced significant growth in recent years, fueled by increasing wealth among its own population as well as accelerating global demand for cheap, effective medicines to treat ailments ranging from high cholesterol to HIV/AIDS. Along with India, China supplies more than 40 percent of the active pharmaceutical ingredients (API) used to make U.S. pharmaceuticals. The current financial crisis, and the limited resources and tighter budgets it has engendered, may accelerate the trend. Yet, China is dogged by a history of poor-quality pharmaceuticals that have killed hundreds and sickened thousands of its own citizens and people across the globe. The government has begun to tighten its laws, but enforcement remains weak, and official obfuscation is rampant. While any retaliatory protectionist measures in the United States would be counterproductive, China and its international partners would gain from improving the frequency and technical sophistication of inspections, the prosecution of perpetrators, and the culture of self-policing within China's pharmaceutical industry.