Approaching China´s Pharmaceutical Market als eBook Download von - nouveau livre

EAN (ISBN-13): 9783319155760
Date de parution: 2015
Editeur: Springer-Verlag

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ISBN/EAN: 9783319155760

ISBN - Autres types d'écriture:
978-3-319-15576-0
Autres types d'écriture et termes associés:
Auteur du livre: ming, fritz springer, schölz schölz, fritz scholz
Titre du livre: china and beyond

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Données de l'éditeur

Auteur: Ming Q. Lu
Titre: Approaching China's Pharmaceutical Market - A Fundamental Guide to Clinical Drug Development
Editeur: Springer; Springer International Publishing
648 Pages
Date de parution: 2015-07-30
Cham; CH
Imprimé / Fabriqué en
Langue: Anglais
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.