Approaching China's Pharmaceutical Market A Fundamental Guide to Cli
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
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Ming Q. Lu Editor
Approaching China’s Pharmaceutical Market A Fundamental Guide to Clinical Drug Development
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Editor Ming Q. Lu Helsinn Therapeutics Inc. Bridgewater New Jersey USA
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. ISBN 978-3-319-15575-3 ISBN 978-3-319-15576-0 (eBook) DOI 10.1007/978-3-319-15576-0 Library of Congress Control Number: 2015943073 Springer Cham Heidelberg New York Dordrecht London © Springer International Publishing Switzerland 2015 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. Printed on acid-free paper Springer International Publishing AG Switzerland is part of Science+Business Media (www.springer.com)
Preface
Since its opening in the early 1980’s, China’s pharmaceutical market has been burgeoning at a breathtaking rate. According to the China Pharmaceutical Market Report (2012), it has been and
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