Page 79 - 2021 Taiwan Food and Drug Administration Annual Report
P. 79
SUDFWLFH QRW RQO\ VKRUWHQ WKH WLPHOLQH EXW subsidy measures for phar-
DOVR SURYLGHV WKH PRVW LPPHGLDWH OHJDO maceutical companies
technical consultation and guidance. On
$SULO WKH &'( DQQRXQFHG WKH Since the implementation of relief
“CDE can Help: COVID-19 Regulatory subsidy measures for pharmaceutical
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free consultation and counseling for the applications from 8 western medicine sellers
cases of COVID-19 drugs that have been have applied as of the end of 2020. 6 items of
selected. 4 applications for relief subsidies have been
(II) TFDA established the “Registration DSSURYHG ZLWK D WRWDO RI 17
Platform for Intention to Participate in
&29,' 9DFFLQH &OLQLFDO 7ULDOV´ RQ III. Accelerated the review pro-
1RYHPEHU IRU WKRVH SHRSOH ZKR cess of COVID-19 drugs and
are willing to participate in COVID-19 assisted the research and
YDFFLQH FOLQLFDO WULDOV WR UHJLVWHU RQOLQH development of vaccines
assisting accelerate the clinical trials in
domestic vaccine. , $V RI WKH HQG RI DSSOLFDWLRQV
have been included in project consultation
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I. Reinforced drug management products. Three domestic COVID-19
during the pandemic control YDFFLQHV HQWHUHG SKDVH FOLQLFDO WULDOV
period one of which entered phase 2 of clinical
trials at the end of the same year. A
,Q WKHUH ZHUH D WRWDO RI DSSOLFD- special approval has been granted to the
tions for the new APIs source of medicinal LPSRUW OLFHQVH RI D &29,' GUXJ
SURGXFWV DQG QHDUO\ DSSOLFDWLRQV RI Remdesivir. TFDA will continue to
importing raw materials for domestic phar- provide consultation with the COVID-19
maceutical use. TFDA accelerated the review drugs and vaccines under the development
of the sources of new APIs and shortened to help them launch in the market as
the announcement period by half to prevent quickly as possible.
shortages. By strengthening the supply mech-
DQLVP RI GUXJ WKH VWDEOH VXSSO\ RI GUXJV ZDV ,, )URP 1RYHPEHU WR 1RYHPEHU
ensured during the pandemic. TFDA also WKH WRWDO QXPEHU RI UHJLVWUDWLRQV WR
coordinated with the distribution of alcohol the “Registration Platform for Intention to
supply to ensure that medical institutions had Participate in COVID-19 Vaccine Clinical
VX൶FLHQW XVDJH VR DV LPSURYH WKH FRQYHQLHQW 7ULDOV´ UHDFKHG 7KH PHGLFDO
access to the public. institutions which conducts clinical trials
can apply for access to the data on the
II. Implementation of relief platform to contact potential participants
in clinical trials of the domestic vaccines.
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