Approaching China's Pharmaceutical Market


Book Description

​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


Book Description




The Commercialization of Pharmaceutical Patents in China


Book Description

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.




Approaching the Medical Industries in China


Book Description

As one of the Series of Approaching China, this book presents a full view of China's medical industries, provides analysis and suggestions on how to approaching this fast growing market. In order to help readers understand the current market environment and know the business rules, culture and characteristics in China, this book includes the introduction on the market shares, competition, key players, market segmentation, import & export changes, sales channel, buyer's behavior, entry barriers, industrial environment and policy trends; introduces the procedure for practicing medical appliance and herb business in China, Chinese inspection & standards system, a list of major importers & agencies and annual trade fairs in China. This book consists of two independent parts, the Guidance for Medical Appliance Market in China and the Guidance for Herb Market in China. In terms of the writing method, for convenience of readers, authors of this book greatly use a form of illustration plus text analysis and presentation. Through the combination of multiple chart forms such as flow chart, system chart, distribution graph, tendency chart and proportion chart, Approaching the Medical Industries in China visually presents readers with a picture of the Chinese market conditions as well as guidance for entry.




Pharmaceutical Patent Protection and World Trade Law


Book Description

Patents, including pharmaceutical patents, enjoy extended protection for twenty years under the TRIPs Agreement. The Agreement has resulted in creating a two-tier system of the World Trade Organisation Member States, and its implementation has seen the price of pharmaceutical products skyrocket, putting essential medicines beyond the reach of the common man. The hardest hit populations come from the developing and least developed countries, which have either a weak healthcare system or no healthcare at all, where access to essential and affordable medicines is extremely difficult to achieve. Pharmaceutical Patent Protection and World Trade Law studies the problems faced by these countries in obtaining access to affordable medicines for their citizens in light of the TRIPS Agreement. It explores the opportunities that are still open for some developing countries to utilise the flexibilities available under the TRIPS Agreement in order to mitigate the damage caused by it. The book also examines the interrelationship between the world governing bodies, and the right to health contained in some of the developing country’s national constitutions.




Dosage Form Design Parameters


Book Description

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




The New Chinese Dream


Book Description

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.




Managing the Drug Discovery Process


Book Description

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