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Unlimited
Authorized users
Authorized users
Document Delivery Supplied
Can lend chapters, not whole ebooks
Title
Approaching China's pharmaceutical market [electronic resource] : a fundamental guide to clinical drug development / Ming Q. Lu, editor.
ISBN
9783319155760 electronic book
3319155768 electronic book
9783319155753
Published
Cham, Switzerland : Springer, 2015.
Language
English
Description
1 online resource : illustrations
Call Number
HD9672.C5
Dewey Decimal Classification
338.4761510951
Summary
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.
Bibliography, etc. Note
Includes bibliographical references and index.
Access Note
Access limited to authorized users.
Preface
Law, Regulation and Guidance
Pharmaceutical Intellectual Property Rights in China
The China Food and Drug Administration (CFDA)
Registration
Guidance for Application Materials/Booklets (Chemical)
New Investigational Drug Application
Clinical Development of Investigational New Drug
Strategic Drug Development in China and Surrounding Countries
Drug Safety Monitoring and Reporting Systems in China
In Vitro Diagnostic Development
Index.
