Approaching China´s Pharmaceutical Market als eBook Download von - new book

EAN (ISBN-13): 9783319155760
Publishing year: 2015
Publisher: Springer-Verlag

Book in our database since 2015-09-30T21:07:36+01:00 (London)
Detail page last modified on 2023-10-19T00:13:57+01:00 (London)
ISBN/EAN: 9783319155760

ISBN - alternate spelling:
978-3-319-15576-0
Alternate spelling and related search-keywords:
Book author: ming, fritz springer, schölz schölz, fritz scholz
Book title: china and beyond

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Information from Publisher

Author: Ming Q. Lu
Title: Approaching China's Pharmaceutical Market - A Fundamental Guide to Clinical Drug Development
Publisher: Springer; Springer International Publishing
648 Pages
Publishing year: 2015-07-30
Cham; CH
Printed / Made in
Language: English
149,79 € (DE)
154,00 € (AT)
177,00 CHF (CH)
Available
XVI, 648 p. 54 illus., 38 illus. in color.

EA; E107; eBook; Nonbooks, PBS / Technik/Chemische Technik; Medizinische Chemie, Pharmazeutische Chemie; Verstehen; CFDA; FDA; drug management law; investigational drug; regulatory guidance; B; Pharmaceutical Sciences/Technology; Pharmaceutics; Biomedical and Life Sciences; BB

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.