In Vitro Diagnostic Industry In China

This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of eight parts, including the overview on the IVD industry in China in 2019, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, molecular diagnosis, blood and body fluid diagnosis, microbial detection, point-of-care testing, laboratory assembly line, etc. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.

This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of eight parts, including the overview on the IVD industry in China in 2019, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, molecular diagnosis, blood and body fluid diagnosis, microbial detection, point-of-care testing, laboratory assembly line, etc. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.

This book systematically describes the achievements and current situation of in vitro diagnostic (IVD) industry in China. It consists of twelve parts, including the overview on the IVD industry in China in 2021, hot technologies and products of IVD industry, academic, technological and product development in the field of IVD, such as biochemical diagnosis, immune-diagnosis, point-of-care testing, molecular diagnosis, blood and body fluid diagnosis, microbial detection, laboratory assembly line, etc. In this second edition, the new contents added include the development of new coronavirus molecular diagnostic products, flight mass spectrometry, tandem mass spectrometry, tumor markers, ELISA immune reagents, autoimmune diagnostics, concomitant diagnosis, fecal and intestinal microecology detection, pathological diagnosis, raw materials for in vitro diagnostic reagents, standard substances and quality controls for in vitro diagnostic reagents, etc., making the content of the whole book more novel and rich. This book is compiled by an editorial committee composed of well-known entrepreneurs, experts and professors in IVD industry in China. It is a reference book for practitioners of IVD industry, medical laboratory and medical staffs all over the world.

​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.

The objective of the list is to help countries develop or update their national essential diagnostics lists, raise awareness and political will, guide procurement and regulation policies and improve access to the most important in vitro diagnostics that all countries need to make available to their populations, particularly in low-resourced countries. It will also contribute towards health systems strengthening and realizing universal health coverage.

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.

Companion and Complementary Diagnostics: From Biomarker Discovery to Clinical Implementation provides readers with in-depth insights into the individual steps in the development of companion diagnostic assays, from the early biomarker discovery phase straight through to final regulatory approval. Further, the clinical implementation of companion diagnostic testing in the clinic is also discussed. As the development of predictive or selective biomarker assays linked to specific drugs is substantially increasing, this book offers comprehensive information on this quickly-evolving area of biomedicine. It is an essential resource for those in academic institutions, hospitals and pharma, and biotech and diagnostic commercial companies. Covers all aspects, from biomarker discovery, to development and regulatory approval Explains the "how to" aspects of companion diagnostics Incorporates information on the entire process, allowing for easier and deeper understanding of the topic

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.