Page 44 - 2021 Taiwan Food and Drug Administration Annual Report
P. 44
To actively improve the related laws and -DQXDU\
UHJXODWLRQV 7)'$ LVVXHG DQ DPHQGPHQW WR ,,, 2Q -XO\ LW ZDV DQQRXQFHG WKDW
Article 53-1 of the Pharmaceutical Affairs
Act XQGHU WKH 3UHVLGHQWLDO 'HFUHH RQ -XQH pharmaceutical companies that handle
2017. The regulations specify that businesses WKH GLVWULEXWLRQ LPSRUW DQG H[SRUW RI
HQJDJHG LQ WKH ZKROHVDOLQJ LPSRUWLQJ DQG active pharmaceutical ingredients of
exporting of western medicines should meet western medicine shall comply with the
WKH UHTXLUHPHQWV RI WKH *'3 DQG WKHLU EXVL- Good Distribution Practice for Western
nesses can only be implemented after passing 0HGLFLQHV VWDUWLQJ -DQXDU\
the inspection and obtaining the western
pharmaceuticals distribution license by the III. Implemented the GDP related
central health competent authority. supplementary measures
In conjunction with the amendments TFDA has progressively promoted the
to the Pharmaceutical Affairs Act, relevant distribution and management system of
management measures were formulated western medicines since 2011 and provided
RQ 'HFHPEHU DQG 0D\ consultation and educational training to the
UHVSHFWLYHO\ VSHFLI\LQJ UHJXODWLRQV RQ WKH EXVLQHVV RSHUDWRUV LQ WKH LQGXVWU\ LQFOXGLQJ
application for inspection and issuance of FRQWLQXLQJ WR FRQGXFW WRSLF IRUXPV WHFKQL-
licenses. FDO VHPLQDUV DQG OHVVRQV IRU SKDUPDFHXWLFDO
firms. TFDA also invited GDP experts to
II. Implementation timeline of SURYLGH RQ VLWH FRXQVHOLQJ D WRWDO RI VHV-
GDP sions; TFDA actively communicates with the
industry to promote related management pol-
, 2Q )HEUXDU\ WKH 0LQLVWU\ LFLHV DQG WLPHOLQH DQG UHDFKHG D FRQVHQVXV
of Health and Welfare announced that ZH FUHDWHG D 3,& 6 *'3 DUHD RQ WKH R൶FLDO
manufacturers of western medicines website of TFDA and announced the GDP
and drug business operators who have regulations to be used as a reference for the
obtained a drug license for western shall business operators.
comply with the Good Distribution
Practice for Western Medicines starting $FKLHYHPHQWV DQG %HQH¿WV
-DQXDU\
$V RI WKH HQG RI D WRWDO RI
,, 2Q 0D\ LW ZDV DQQRXQFHG WKDW western pharmaceutical manufacturers and
pharmaceutical companies of the western pharmacy operators have fulfilled the GDP
medicine preparations that require cold VWDQGDUG ZKLFK KDV DWWDLQHG RI WKH ¿UPV
chain storage and transportation shall LQ WKH ¿UVW VWDJH WR HQVXUH WKH TXDOLW\ RI GUXJ
comply with the Good Distribution storage and transportation as well as the qual-
Practice for Western Medicines starting ity and safety of the public’s drugs usage.
42
