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Approaching China`s Pharmaceutical Market - Ming Q. Lu
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ISBN: 9783319155760

ID: 9783319155760

A Fundamental Guide to Clinical Drug Development ¿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 China`s Pharmaceutical Market: ¿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. CFDA FDA drug management law investigational drug regulatory guidance B Pharmaceutical Sciences/Technology Biomedical and Life Sciences, Springer International Publishing

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Approaching China`s Pharmaceutical Market - Ming Q. Lu
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Approaching China`s Pharmaceutical Market - neues Buch

ISBN: 9783319155760

ID: 9783319155760

A Fundamental Guide to Clinical Drug Development ¿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 China`s Pharmaceutical Market: ¿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. Arznei - Arzneimittel Medikament Arzneimittel ( Arznei ) Pharmaka Tablette MEDICAL / Pharmacy, Springer-Verlag Gmbh

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Approaching China´s Pharmaceutical Market:A Fundamental Guide to Clinical Drug Development. 1st ed. 2015. Approaching China´s Pharmaceutical Market:A Fundamental Guide to Clinical Drug Development. 1st ed. 2015. eBooks > Fachthemen & Wissenschaft > Medizin, Springer International Publishing

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A Fundamental Guide to Clinical Drug Development. 1st ed. 2015. A Fundamental Guide to Clinical Drug Development. 1st ed. 2015. eBooks > Fachthemen Wissenschaft > Medizin

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2015, ISBN: 9783319155760

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A Fundamental Guide to Clinical Drug Development, [ED: 1], Auflage, eBook Download (PDF), eBooks, [PU: Springer-Verlag]

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Approaching China`s Pharmaceutical Market
Autor:

Ming Q. Lu

Titel:

Approaching China`s Pharmaceutical Market

ISBN-Nummer:

9783319155760

Detailangaben zum Buch - Approaching China`s Pharmaceutical Market


EAN (ISBN-13): 9783319155760
Erscheinungsjahr: 2015
Herausgeber: Springer-Verlag Gmbh

Buch in der Datenbank seit 30.09.2015 22:07:36
Buch zuletzt gefunden am 07.02.2017 21:01:07
ISBN/EAN: 9783319155760

ISBN - alternative Schreibweisen:
978-3-319-15576-0

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