Page 94 - 2020Taiwan Food and Drug Administration Annual Report

"QQFOEJY c*NQPSUBOU &WFOUT

April "QSJM Convened the “2019 Foreign Pharmaceutical Factory GMP
Management and Communication Meeting” and invited 5 public
associations related to pharmaceutical imports to join the meeting
to continuously improve and implement the management of foreign
pharmaceutical factories.

"QSJM Attended the forum “Promoting the Development of Taiwan to
%HFRPH WKH 5 ' %LRWHFKQRORJ\ &HQWHU LQ $VLD 3DFL¿F” and served
as the representative speaker to report the registration mechanism
IRU QHZ GUXJV ZH IRFXVHG RQ WKH VLPSOL¿HG UHYLHZ SULRULW\ UHYLHZ
accelerated approval and breakthrough therapy mechanism, as well
as the description of multi-regional clinical trials review procedures.
May .BZ We were invited to the “Practices on Foreign Pharmaceutical
Factory Management and Inspection Seminar” WR H[SODLQ WKH
current GMP management status and management system of
foreign pharmaceutical factories.

.BZ The “Regulations for the Management of Regenerative Medicine
Preparations” were reviewed by the Sanitation and Environment
th
Committee of the Legislative Yuan (at the 7 meeting in the 9th session).
st
June +VOF TFDA attended the 1 meeting in 2019 held by the International
&RXQFLO IRU +DUPRQL]DWLRQ RI 7HFKQLFDO 5HTXLUHPHQWV IRU
UP
Pharmaceuticals for Human Use (ICH) and its work group in
+VOF Amsterdam, Netherlands, as well as the meeting held by the
International Pharmaceutical Regulators Program (IPRP) and
the Drug Regulatory Authority (DRA). During the meetings,
we communicated and interacted with representatives of
pharmaceutical regulators from various countries and continuously
enhanced the international visibility and influence of Taiwan
regarding pharmaceutical regulations.

+VOF In response to the first year of “World Food Safety Day,” the
Ministry of Economic Affairs, the “Cross-Ministry Press Conference
for the World Food Safety Day” ZDV MRLQWO\ RUJDQL]HG E\ WKH 0LQLVWU\
RI (GXFDWLRQ WKH &RXQFLO RI $JULFXOWXUH RI WKH ([HFXWLYH <XDQ
and the Environmental Protection Administration, to reinforce our
determination for the protection of food safety from farm to table.

+VOF TFDA conducted the “2019 APEC International Workshop on Food
Safety and Threat from New Psychoactive Substances” to share
UP
DQG H[FKDQJH LQIRUPDWLRQ DERXW WKH WHVWLQJ WHFKQRORJ\ IRU 136
+VOF DQG LOOHJDO GUXJ ZLWK H[SHUWV IURP YDULRXV FRXQWULHV WR HQKDQFH WKH
domestic testing technology to protect the health and drug safety of
WKH FLWL]HQV LQ 7DLZDQ

+VOF Conducted the “([FHOOHQW )RRG 6XSSOLHUV $ZDUG &HUHPRQ\ RQ WKH
World Food Safety Day” WR SXEOLFO\ SUHVHQW DZDUGV WR H[FHOOHQW IRRG
VXSSOLHUV :LWK WKH DZDUG DQG UHFRJQLWLRQ LW LV H[SHFWHG WR HQFRXUDJH
more businesses to voluntarily apply for verification to enhance the
RYHUDOO VDIHW\ DQG K\JLHQLF TXDOLW\ RI WKH IRRG LQGXVWU\ LQ WKH QDWLRQ

st
+VOF TFDA hosted the “1 3,& 6 ([SHUW &LUFOH 0HHWLQJ RQ &RQWURO RI &URVV
Contamination” in Taipei in 2019, to learn and discuss the inspection
UP
skills of the risk management of cross-contamination in shared facilities
+VOF ZLWK LQVSHFWRUV DQG H[SHUWV IURP YDULRXV FRXQWULHV.

92