Approaching China's Pharmaceutical Market A Fundamental Guide to Clinical Drug Development /

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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 strat...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor Corporativo: SpringerLink (Online service)
Otros Autores: Lu, Ming Q. (Editor )
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Cham : Springer International Publishing : Imprint: Springer, 2015.
Edición:1st ed. 2015.
Temas:
Pharmaceutical chemistry.
Pharmaceutics.
Acceso en línea:Texto Completo

MARC

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245 1 0 |a Approaching China's Pharmaceutical Market  |h [electronic resource] :  |b A Fundamental Guide to Clinical Drug Development /  |c edited by Ming Q. Lu. 
250 |a 1st ed. 2015. 
264 1 |a Cham :  |b Springer International Publishing :  |b Imprint: Springer,  |c 2015. 
300 |a XVI, 648 p. 54 illus., 38 illus. in color.  |b online resource. 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
347 |a text file  |b PDF  |2 rda 
505 0 |a Preface -- Law, Regulation and Guidance -- Pharmaceutical Intellectual Property Rights in China -- The China Food and Drug Administration (CFDA) -- Registration -- Guidance for Application Materials/Booklets (Chemical) -- New Investigational Drug Application -- Clinical Development of Investigational New Drug -- Strategic Drug Development in China and Surrounding Countries -- Drug Safety Monitoring and Reporting Systems in China -- In Vitro Diagnostic Development -- Index. 
520 |a 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. 
650 0 |a Pharmaceutical chemistry. 
650 1 4 |a Pharmaceutics. 
700 1 |a Lu, Ming Q.  |e editor.  |4 edt  |4 http://id.loc.gov/vocabulary/relators/edt 
710 2 |a SpringerLink (Online service) 
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776 0 8 |i Printed edition:  |z 9783319365718 
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950 |a Biomedical and Life Sciences (SpringerNature-11642) 
950 |a Biomedical and Life Sciences (R0) (SpringerNature-43708) 

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