Page 133 - 2019食藥署年報(英文版)

$BUFHPSZ 0VUDPNFT #FOFGJUT
Biologics and 3UHSDUDWLRQ RI WKH FDQGLGDWH VWDQGDUG IRU WKH VHFRQG JHQHUDWLRQ ,Q DGGLWLRQ WR WKH TXDOLW\
emerging +%9 JHQRW\SH % YLUXV QXFOHLF DFLG PDQDJHPHQW EHIRUH DQG
biotechnology &RPSOHWHG WKH IHDVLELOLW\ DQG WHVW PHWKRGV IRU WKH HQWHURYLUXV DIWHU WKH SURGXFW HQWHULQJ
medicinal products (9 $ DQWLJHQ WKH IHDVLELOLW\ DVVHVVPHQW RI SODFHQWDO WLVVXH WKH PDUNHW WKH ELRORJLFDO
VXEVWDQFH DQG WKH SUHSDUDWLRQ DQG IHDVLELOLW\ HYDOXDWLRQ IRU WKH VWDQGDUGV FDQ DOVR EH XVHG
GHQJXH YLUXV 16 DQWLJHQ DV SURGXFW GHYHORSPHQW
(VWDEOLVKHG WKH SURWHLQ GDWD IRU WKH PRQRFORQDO DQWLERG\ DQG TXDOLW\ FRQWURO IRU WKH
SUHSDUDWLRQV RI %HYDFL]XPDE DQG WKH WHVW DQG DQDO\VLV PHWKRGV industry.
for the physicochemical properties and functionalities. 7KH HVWDEOLVKHG LQVSHFWLRQ
&RPSOHWHG WKH UHYLVLRQ RI WKH DUWLFOHV LQ ELRSKDUPDFHXWLFDO PHWKRG FDQ EH DSSOLHG IRU
WHVWLQJ VWDQGDUGV DQG GRFXPHQWHG WKH UHYLVHG WKH TXDOLW\ FRQWURO IRU WKH
ELRSKDUPDFHXWLFDO DUWLFOHV IURP WKH SUHYLRXV \HDU WR WKH HLJKWK SURGXFWV RQ WKH PDUNHW WR
HGLWLRQ RI WKH &KLQHVH 3KDUPDFRSRHLD HIIHFWLYHO\ FRQWURO WKH SURGXFW
TXDOLW\ DQG HQVXUH WKH VDIHW\
RI WKH FLWL]HQV
7KH ELRSKDUPDFHXWLFDO
WHVWLQJ VWDQGDUGV ZLOO EH
LQFOXGHG LQ WKH &KLQHVH
Pharmacopoeia and it can
EH XVHG DV D UHIHUHQFH IRU
WKH TXDOLW\ LQVSHFWLRQ DQG
FRQWURO RI ELRSKDUPDFHXWLFDO
products.

Medical devices and &RPSOHWHG RQH GUDIW RI WKH KHPRVWDVLV HYDOXDWLRQ DQG WHVW PHWKRG 3ODQQLQJ WR UHYHDO WKH
cosmetics &RPSOHWHG WKH LQWHQVLYH OHYHO IRU WKH DGGLWLYH PDQXIDFWXULQJ test methods for domestic
DUWL¿FLDO LQWHUYHUWHEUDO LPSODQWV DQG GUDIW RI IDWLJXH WHVW PHWKRG DGPLQLVWUDWLYH XQLWV DQG
&RPSOHWHG WKH PHWKRG IRU WKH ILOWUDWLRQ SHUIRUPDQFH RI VSHFLDO SULYDWH LQVSHFWLRQ XQLWV
ZDYHOHQJWK UDQJH LQ WKH FRUUHFWLYH OHQVHV 8VLQJ WKH GHYHORSHG WHVW
&RPSOHWH WKH WHVW PHWKRG RI DJHQW UHVLGXH LQ K\DOXURQLF DFLG DQG PHWKRGV IRU WKH VXSHUYLVLRQ
GUXJ DEXVH HYDOXDWH RI LQ YLWUR GLDJQRVWLF HI¿FDF\ RI SRVW PDUNHW SURGXFWV
&UHDWH WHVW PHWKRGV IRU WKH IROORZLQJ WKUHH NLQGV RI FDQQDELQRLGV

VXFK DV WHWUDK\GURFDQQDELQRO ǻ 7+& FDQQDELGLRO &%' DQG
FDQQDELQRO &%1 LQ FRVPHWLFV QLQH KHDY\ PHWDOV VXFK DV DUVHQLF
$V OHDG 3E DQG FDGPLXP &G NLQGV RI EDQQHG DQG UHVWULFWHG
SUHVHUYDWLYHV VXFK DV ,RGRSURS\Q\O EXW\OFDUEDPDWH ,3%& NLQGV
RI EDQQHG LQJUHGLHQWV VXFK DV 6DIUROH DQG NLQGV RI EDQQHG IRRG
FRORULQJV
7KH PHWKRG RI WHVW IRU DVEHVWRV ZDV HVWDEOLVKHG E\ XVLQJ ;5'
DQG 6(0 ('6 PDSSLQJ ZLWK D UHIHUHQFH WR WKH LQWHUQDWLRQDO
standards.

131