Page 78 - 2021 Taiwan Food and Drug Administration Annual Report
P. 78
DGYDQFH ,Q WHUPV RI DOFRKRO VXSSO\ LQ tional difficulties
addition to accelerating the reviewing
process to assist medicinal alcohol Since the pandemic affects the drug
manufacturers for changing raw material VXSSO\ FKDLQ LW DOVR LQFUHDVHV WKH FRVW RI
VXSSO\ 7)'$ FRRUGLQDWHG ZLWK WZR $3,V DQG SUHSDUDWLRQV ZKLFK DOVR GHFUHDVHV
major state-owned enterprises to produce the willingness or capability of drug
pandemic control alcohol to ensure the manufacturers to manufacture or import
VX൶FLHQW VXSSO\ RI DOFRKRO GUXJV 8QGHU WKLV FLUFXPVWDQFH 7)'$ KDV
(II) In order to prevent drug stockpiling and proposed relief subsidies for drug companies
XQHYHQ VXSSO\ FDXVHG E\ WKH SDQGHPLF in the Compensation and Relief Measures
TFDA issued the “Management Principles IRU 0HGLFDO ,QVWLWXWLRQV (QWHUSULVHV DQG
for Drug Supply During the COVID-19 Industries due to the Impact of Severe
3 D Q G H P L F ´ R Q 0 D U F K 3QHXPRQLD ZLWK 1RYHO 3DWKRJHQV ZKLFK ZDV
requiring that pharmaceutical companies DQQRXQFHG DQG LPSOHPHQWHG RQ 0DUFK
to distribute drugs to medical care 2020. Pharmaceutical companies that meet
LQVWLWXWLRQV DQG SKDUPDFLHV DQG PHGLFDO the requirements for operational difficulties
care institutions or pharmacies to purchase can receive subsidies for manufacturing or
GUXJV ZKLFK LV EDVHG RQ WKH PRQWKO\ VDOH importing expense of drugs to relieve the
in the past year. If the quantity exceeds the pressure of competition of raw materials and
average monthly sale in the past year by VXSSOLHV $SDUW IURP WKDW LW DOVR VWDELOL]HV WKH
PRUH WKDQ UHDVRQV DQG VXSSRUWLQJ drug supply chain and maintains the operation
documents must be submitted to TFDA RI WKH PHGLFDO FDUH V\VWHP $W WKH VDPH WLPH
for approval. relevant information is also integrated into
(III)TFDA announced and implemented the webpage of the Ministry of Health and
the “Guidelines for the Management of Welfare and which is accessible for industry
Uneven Distribution of Medicines During practitioners.
the COVID-19 Pandemic´ RQ $SULO
WR H൵HFWLYHO\ KDQGOH LVVXHV VXFK DV III. Accelerated the review pro-
excessive order of medical care institutions cess of COVID-19 drugs and
and an increase of drug inventory caused assisted the research and
E\ WKH GHFUHDVH LQ RXWSDWLHQW YLVLWV $OVR D development of vaccines
dedicated reporting mailbox (tfdawatch@
fda.gov.tw) was established for reporting (I) In order to speed up the launching of
GUXJ VWRFNSLOLQJ XQHYHQ GLVWULEXWLRQ HWF domestic vaccine and maintain the quality
to facilitate the follow-up investigations. DQG VDIHW\ RI WKH YDFFLQH 7)'$ DQG WKH
Center for Drug Evaluation (CDE) became
II. Formulated relief measures D SURMHFW FRQVXOWLQJ DQG FRXQVHOLQJ WHDP
for drug sellers with opera- which held weekly discussion meetings
with manufacturers. The rolling review
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