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Approaching China's Pharmaceutical Market

Author: Ming Q. Lu

Publisher: Springer

Published: 2015-07-30

Total Pages: 657

ISBN-13: 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.

Book Synopsis Approaching China's Pharmaceutical Market by : Ming Q. Lu

Download or read book Approaching China's Pharmaceutical Market written by Ming Q. Lu and published by Springer. This book was released on 2015-07-30 with total page 657 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

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

Author: Kung-Chung Liu

Publisher: Springer Nature

Published: 2019-09-06

Total Pages: 513

ISBN-13: 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.

Book Synopsis Innovation, Economic Development, and Intellectual Property in India and China by : Kung-Chung Liu

Download or read book Innovation, Economic Development, and Intellectual Property in India and China written by Kung-Chung Liu and published by Springer Nature. This book was released on 2019-09-06 with total page 513 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Author: James Hou

Publisher: Edward Elgar Publishing

Published: 2021-03-28

Total Pages: 352

ISBN-13: 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.

Book Synopsis The Commercialization of Pharmaceutical Patents in China by : James Hou

Download or read book The Commercialization of Pharmaceutical Patents in China written by James Hou and published by Edward Elgar Publishing. This book was released on 2021-03-28 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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's Healthcare System and Reform

Author: Lawton Robert Burns

Publisher: Cambridge University Press

Published: 2017-01-26

Total Pages: 929

ISBN-13: 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.

Book Synopsis China's Healthcare System and Reform by : Lawton Robert Burns

Download or read book China's Healthcare System and Reform written by Lawton Robert Burns and published by Cambridge University Press. This book was released on 2017-01-26 with total page 929 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 New Chinese Dream

Author: Francesca Spigarelli

Publisher: Springer Nature

Published: 2021-05-28

Total Pages: 148

ISBN-13: 3030698122

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This volume describes the most salient changes faced by key Chinese industry sectors as defining components of global and domestic macroeconomic performance. Set within the context of the Global China 2049 initiative, which aims to transform the country into a fully advanced and developed nation, chapters focus specifically on industrial policies that are considered to be one of the main determinants of Chinese growth. Covering sectors such as healthcare, aerospace, microprocessors and other data driven industries, chapters highlight the pitfalls and anticipated successes of Chinese firms operating in the global competitive market. Importantly, the book fosters debate on how Chinese industries will achieve competitive growth in the post-pandemic era. Ultimately the book discusses the likelihood of China achieving a leading position in terms of processes and innovation and suggests a road to future research on China’s industrial trajectory. Francesca Spigarelli is Associate Professor of Applied Economics, at the University of Macerata and Director of the China Center. She is Vice Rector for Entrepreneurship and Technological Transfer and for European research policy and is member of the board of Chinese Globalization Association (www.chinagoesglobal.org). John McIntyre has been Director of the Georgia Tech Center for International Business Education and Research (CIBER), a national center of excellence, since 1993 and a full Professor of International Business Management and International Relations with joint appointments in the College of Management and the Sam Nunn School of International Affairs of the Georgia Institute of Technology, Atlanta, Georgia.

Book Synopsis The New Chinese Dream by : Francesca Spigarelli

Download or read book The New Chinese Dream written by Francesca Spigarelli and published by Springer Nature. This book was released on 2021-05-28 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume describes the most salient changes faced by key Chinese industry sectors as defining components of global and domestic macroeconomic performance. Set within the context of the Global China 2049 initiative, which aims to transform the country into a fully advanced and developed nation, chapters focus specifically on industrial policies that are considered to be one of the main determinants of Chinese growth. Covering sectors such as healthcare, aerospace, microprocessors and other data driven industries, chapters highlight the pitfalls and anticipated successes of Chinese firms operating in the global competitive market. Importantly, the book fosters debate on how Chinese industries will achieve competitive growth in the post-pandemic era. Ultimately the book discusses the likelihood of China achieving a leading position in terms of processes and innovation and suggests a road to future research on China’s industrial trajectory. Francesca Spigarelli is Associate Professor of Applied Economics, at the University of Macerata and Director of the China Center. She is Vice Rector for Entrepreneurship and Technological Transfer and for European research policy and is member of the board of Chinese Globalization Association (www.chinagoesglobal.org). John McIntyre has been Director of the Georgia Tech Center for International Business Education and Research (CIBER), a national center of excellence, since 1993 and a full Professor of International Business Management and International Relations with joint appointments in the College of Management and the Sam Nunn School of International Affairs of the Georgia Institute of Technology, Atlanta, Georgia.

Dosage Form Design Parameters

Author:

Publisher: Academic Press

Published: 2018-07-25

Total Pages: 810

ISBN-13: 012814422X

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Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

Book Synopsis Dosage Form Design Parameters by :

Download or read book Dosage Form Design Parameters written by and published by Academic Press. This book was released on 2018-07-25 with total page 810 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dosage Form Design Parameters, Volume II, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries. Examines the history and recent developments in drug dosage forms for pharmaceutical sciences Focuses on physicochemical aspects, prefomulation solid state properties and polymorphism Contains extensive references for further discovery and learning that are appropriate for advanced undergraduates, graduate students and those interested in drug dosage design

China

Author: Ross Garnaut

Publisher: ANU E Press

Published: 2012-12-01

Total Pages: 500

ISBN-13: 192214455X

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Twenty-five years of reform have transformed China from a centrally planned and closed system to a predominantly market-driven and open economy. As a consequence, China is emerging as the new powerhouse for the world economy. China: new engine for world growth discusses the impact and significance of this transformation. It points out risks to the growth process and unfinished tasks of reform. It presents conclusions from recent research on growth, trade and investment, the financial sector, income and regional disparities, industrial location and private sector development.

Book Synopsis China by : Ross Garnaut

Download or read book China written by Ross Garnaut and published by ANU E Press. This book was released on 2012-12-01 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Twenty-five years of reform have transformed China from a centrally planned and closed system to a predominantly market-driven and open economy. As a consequence, China is emerging as the new powerhouse for the world economy. China: new engine for world growth discusses the impact and significance of this transformation. It points out risks to the growth process and unfinished tasks of reform. It presents conclusions from recent research on growth, trade and investment, the financial sector, income and regional disparities, industrial location and private sector development.

Imitation to Innovation in China

Author: Yahong Li

Publisher: Edward Elgar Publishing

Published: 2010

Total Pages: 0

ISBN-13: 9781848442061

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Following decades in which China's approach to technology has been to imitate, the country is now transforming itself to become innovation-oriented. This pioneering study examines whether patents play a similar role in promoting innovation in China as they do in the West, exploring the interplay between patents and China's biotechnology and pharmaceutical industries in particular.

Book Synopsis Imitation to Innovation in China by : Yahong Li

Download or read book Imitation to Innovation in China written by Yahong Li and published by Edward Elgar Publishing. This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following decades in which China's approach to technology has been to imitate, the country is now transforming itself to become innovation-oriented. This pioneering study examines whether patents play a similar role in promoting innovation in China as they do in the West, exploring the interplay between patents and China's biotechnology and pharmaceutical industries in particular.

Comparative Approaches to Biotechnology Development and Use in Developed and Emerging Nations

Author: Bas, Tomas Gabriel

Publisher: IGI Global

Published: 2016-10-19

Total Pages: 592

ISBN-13: 1522510419

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The development of biotechnological innovations is quickly becoming a globalized phenomenon as emerging nations are making major strides to compete with more developed economies. Though efforts to bridge the gap between emerging and developed nations have been successful, there are still many barriers that need to be overcome. Comparative Approaches to Biotechnology Development and Use in Developed and Emerging Nations evaluates the importance of manufacturing biotechnological products around the world. Highlighting a comparative analysis of public policies, technological policies, innovations, and marketing capabilities of developed and emerging nations, this publication is a pivotal reference source for government officers, policy makers, academics, and practitioners.

Book Synopsis Comparative Approaches to Biotechnology Development and Use in Developed and Emerging Nations by : Bas, Tomas Gabriel

Download or read book Comparative Approaches to Biotechnology Development and Use in Developed and Emerging Nations written by Bas, Tomas Gabriel and published by IGI Global. This book was released on 2016-10-19 with total page 592 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development of biotechnological innovations is quickly becoming a globalized phenomenon as emerging nations are making major strides to compete with more developed economies. Though efforts to bridge the gap between emerging and developed nations have been successful, there are still many barriers that need to be overcome. Comparative Approaches to Biotechnology Development and Use in Developed and Emerging Nations evaluates the importance of manufacturing biotechnological products around the world. Highlighting a comparative analysis of public policies, technological policies, innovations, and marketing capabilities of developed and emerging nations, this publication is a pivotal reference source for government officers, policy makers, academics, and practitioners.

Managing the Drug Discovery Process

Author: Walter Moos

Publisher: Woodhead Publishing

Published: 2016-11-08

Total Pages: 536

ISBN-13: 0081006322

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Managing the Drug Discovery Process: How to Make It More Efficient and Cost-Effective thoroughly examines the current state of pharmaceutical research and development by providing chemistry-based perspectives on biomedical research, drug hunting and innovation. The book also considers the interplay of stakeholders, consumers, and the drug firm with attendant factors, including those that are technical, legal, economic, demographic, political, social, ecological, and infrastructural. Since drug research can be a high-risk, high-payoff industry, it is important to researchers to effectively and strategically manage the drug discovery process. This book takes a closer look at increasing pre-approval costs for new drugs and examines not only why these increases occur, but also how they can be overcome to ensure a robust pharmacoeconomic future. Written in an engaging manner and including memorable insights, this book is aimed at redirecting the drug discovery process to make it more efficient and cost-effective in order to achieve the goal of saving countless more lives through science. A valuable and compelling resource, this is a must-read for all students and researchers in academia and the pharmaceutical industry. Considers drug discovery in multiple R&D venues, including big pharma, large biotech, start-up ventures, academia, and nonprofit research institutes Analyzes the organization of pharmaceutical R&D, taking into account human resources considerations like recruitment and configuration, management of discovery and development processes, and the coordination of internal research within, and beyond, the organization, including outsourced work Presents a consistent, well-connected, and logical dialogue that readers will find both comprehensive and approachable

Book Synopsis Managing the Drug Discovery Process by : Walter Moos

Download or read book Managing the Drug Discovery Process written by Walter Moos and published by Woodhead Publishing. This book was released on 2016-11-08 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: Managing the Drug Discovery Process: How to Make It More Efficient and Cost-Effective thoroughly examines the current state of pharmaceutical research and development by providing chemistry-based perspectives on biomedical research, drug hunting and innovation. The book also considers the interplay of stakeholders, consumers, and the drug firm with attendant factors, including those that are technical, legal, economic, demographic, political, social, ecological, and infrastructural. Since drug research can be a high-risk, high-payoff industry, it is important to researchers to effectively and strategically manage the drug discovery process. This book takes a closer look at increasing pre-approval costs for new drugs and examines not only why these increases occur, but also how they can be overcome to ensure a robust pharmacoeconomic future. Written in an engaging manner and including memorable insights, this book is aimed at redirecting the drug discovery process to make it more efficient and cost-effective in order to achieve the goal of saving countless more lives through science. A valuable and compelling resource, this is a must-read for all students and researchers in academia and the pharmaceutical industry. Considers drug discovery in multiple R&D venues, including big pharma, large biotech, start-up ventures, academia, and nonprofit research institutes Analyzes the organization of pharmaceutical R&D, taking into account human resources considerations like recruitment and configuration, management of discovery and development processes, and the coordination of internal research within, and beyond, the organization, including outsourced work Presents a consistent, well-connected, and logical dialogue that readers will find both comprehensive and approachable