Page 46 - 2021 Taiwan Food and Drug Administration Annual Report
P. 46
WKH SURJUHVV RI GUXJ UHJXODWLRQV WKH FKDO- TFDA attended the 2020 Vancouver
lenges faced by medicine and medical device Conference in Canada and the Athens
management in response to the COVID-19 Conference in Greece as a full member.
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device quality management system (QMS) participate in 27 ICH expert working groups
under the “Taiwan-Japan Medical Device and participated in the formulation of ICH
Quality Management System Collaboration guidelines with other international experts. In
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closed-door meeting was held on October 16 incorporated into the implementation stage
LQ WKH VDPH \HDU WR IXUWKHU GLVFXVV WKH FRRS- to make an active contribution. At the same
eration of drug review and relevant experi- WLPH D ZRUNLQJ JURXS FRQVLVWHG RI H[SHUWV
ence sharing. IURP WKH LQGXVWU\ JRYHUQPHQW DQG DFDGHPLD
was formed in Taiwan to practically
IV. Continued to participate in the understand the needs of the industry and
PIC/S activities FRQGXFW JXLGDQFH WUDLQLQJ RQ ,&+ VR WKDW
these guidelines can be implemented in
(I) The Agency dispatched personnel to par- Taiwan’s pharmaceutical industry quicker
ticipate in PIC/S Webinar meeting of Ex- DQG PRUH H൵HFWLYHO\
pert Circle on Quality Risk Management
held by Turkey/TMDA (Turkish Medi- II. Promoted cooperation and in-
cines and Medical Devices Agency) on teraction of pharmaceutical
6HSWHPEHU $ WRWDO RI SHRSOH management in the Asia-Pacif-
from 53 countries and 3 Associated Part- ic region
ner Organisations attended the meeting.
TFDA convened the APEC GRM
(II) The Agency dispatched personnel to P r i o r i t y Wo r k A r e a ( P WA ) s t e e r i n g
participate in PIC/S Virtual seminar held FRPPLWWHH PHHWLQJ RQ -XO\ WR
by Finland/FIMEA (Finnish Medicines lead and discuss the core issues and plans
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The topic was on Distant Assessment of to strengthen the relationship between the
GMP Compliance. A total of 378 people country various international pharmaceutical
from 48 countries attended the seminar. regulatory agencies. The APEC GRM key
performance indicator questionnaire analysis
$FKLHYHPHQWV DQG %HQH¿WV refines the management capabilities of the
country’s drug administration. The results
I. Contributed to ICH-related meet-
ings
44
