國立虎尾科技大學 |

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

紀錄類型:	書目-語言資料,印刷品 : Monograph/item
正題名/作者:	Approaching China's Pharmaceutical Market/ edited by Ming Q. Lu.
其他題名:	A Fundamental Guide to Clinical Drug Development /
其他作者:	Lu, Ming Q.
面頁冊數:	XVI, 648 p. 54 illus., 38 illus. in color.online resource. :
Contained By:	Springer Nature eBook
標題:	Pharmaceutical technology. -
電子資源:	https://doi.org/10.1007/978-3-319-15576-0
ISBN:	9783319155760

Approaching China's Pharmaceutical Market = A Fundamental Guide to Clinical Drug Development /
Approaching China's Pharmaceutical MarketA Fundamental Guide to Clinical Drug Development /[electronic resource] :edited by Ming Q. Lu. - 1st ed. 2015. - XVI, 648 p. 54 illus., 38 illus. in color.online resource.

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.

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.

ISBN: 9783319155760

Standard No.: 10.1007/978-3-319-15576-0doiSubjects--Topical Terms:

557391
Pharmaceutical technology.

LC Class. No.: RS380

Dewey Class. No.: 615.19

Approaching China's Pharmaceutical Market = A Fundamental Guide to Clinical Drug Development /
LDR:03119nam a22004095i 4500 001 963227
003 DE-He213
005 20200702221024.0
007 cr nn 008mamaa
008 201211s2015 gw | s |||| 0|eng d
020 $a 9783319155760 $9 978-3-319-15576-0
024 7 $a 10.1007/978-3-319-15576-0 $2 doi
035 $a 978-3-319-15576-0
050 4 $a RS380
050 4 $a RS190-210
072 7 $a TDCW $2 bicssc
072 7 $a MED072000 $2 bisacsh
072 7 $a TDC $2 thema
082 0 4 $a 615.19 $2 23
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 technology. $3 557391
650 1 4 $a Pharmaceutical Sciences/Technology. $3 768561
700 1 $a Lu, Ming Q. $4 edt $4 http://id.loc.gov/vocabulary/relators/edt $3 1066886
710 2 $a SpringerLink (Online service) $3 593884
773 0 $t Springer Nature eBook
776 0 8 $i Printed edition: $z 9783319155753
776 0 8 $i Printed edition: $z 9783319155777
776 0 8 $i Printed edition: $z 9783319365718
856 4 0 $u https://doi.org/10.1007/978-3-319-15576-0
912 $a ZDB-2-SBL
912 $a ZDB-2-SXB
950 $a Biomedical and Life Sciences (SpringerNature-11642)
950 $a Biomedical and Life Sciences (R0) (SpringerNature-43708)