Approaching China´s Pharmaceutical Market als eBook Download von - novo libro

EAN (ISBN-13): 9783319155760
Ano de publicação: 2015
Editor/Editora: Springer-Verlag

Livro na base de dados desde 2015-09-30T21:07:36+01:00 (Lisbon)
Página de detalhes modificada pela última vez em 2023-10-19T00:13:57+01:00 (Lisbon)
Número ISBN/EAN: 9783319155760

Número ISBN - Ortografia alternativa:
978-3-319-15576-0
Ortografia alternativa e termos de pesquisa relacionados:
Autor do livro: ming, fritz springer, schölz schölz, fritz scholz
Título do livro: china and beyond

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Dados da editora

Autor: Ming Q. Lu
Título: Approaching China's Pharmaceutical Market - A Fundamental Guide to Clinical Drug Development
Editora: Springer; Springer International Publishing
648 Páginas
Ano de publicação: 2015-07-30
Cham; CH
Impresso / Feito em
Língua: Inglês
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.