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008			150730s2015 gw | s |||| 0|eng d
020			_a9783319155760
024	7		_a10.1007/978-3-319-15576-0 _2doi
040			_aES-MaUEC
050		4	_aHD9672.C5 _bA67 2015 EB
082	0	4	_a615.19
245	0	0	_aApproaching China's Pharmaceutical Market : _bA Fundamental Guide to Clinical Drug Development _cedited by Ming Q. Lu
260			_aCham, Switzerland _bSpringer _c2015
300			_a1 recurso en línea (XVI, 648 p.) _b54 ilustraciones, 38 ilustraciones en color
336			_aTexto (visual) _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
505	0		_aPreface -- 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			_aThis 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	7	_aIndustria farmacéutica _zChina _9138366 _0LocalX _2embne
700	1		_aLu, Ming Q. _eeditor literario _993743 _0Local
710	2		_aSpringerLink (Online service) _0Local _9106996
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://link.springer.com/book/10.1007/978-3-319-15576-0 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
901			_ai9783319155760
907			_a.b12899616 _b10-10-17 _c18-01-16
942			_2lcc _cLE
945			_aHD9672.C5 A67 2015 EB _g1 _ieBOOK _j0 _lmae _o- _pEUR0.00 _q- _r- _sb _t15 _u0 _v0 _w0 _x0 _y.i11569232 _z06-04-17
988			_aEBOOK, EBSPRINGER
998			_am _a_alco _a_vill _b02-09-17 _cm _dz _ei _feng _ggw _h0