Page 39 - 2021 Taiwan Food and Drug Administration Annual Report
P. 39
Ch3 Reinforced Drug
Management
In order to implement the product life- SXEOLF H[SHGLWHV WKH GUXJ DSSURYDO SURFHVV
cycle management and effectively ensure and also encourages the drug development to
WKH VDIHW\ H൶FDF\ DQG TXDOLW\ RI PHGLFLQDO IXO¿OO WKH PHGLFDO QHHGV RI WKH SXEOLF 7)'$
SURGXFWV 7)'$ DFWLYHO\ SDUWLFLSDWHV continues establishing a comprehensive
in international organizations which drug regulation trends in patent linkage
constructs a regulatory environment and V\VWHP DV ZHOO DV FRRSHUDWLQJ ZLWK WKH
harmonises with international standards to current development status of the domestic
improve domestic regulations of medicine pharmaceutical industry. At the same
management. We continue working on WLPH ZH FRQWLQXH WR LPSURYH WKH UHOHYDQW
YDULRXV DVSHFWV VXFK DV WKH PDQDJHPHQW regulations to provide a better drug regulatory
RI GUXJ UHYLHZLQJ WKH UHJXODWLRQV RI GUXJ environment for the public.
GLVWULEXWLRQ GLJLWDO PDQDJHPHQW WKH
VXSHUYLVLRQ RI TXDOLW\ DQG VDIHW\ DQG DOVR Implementation Strategy
the inspection technology for quality to
further strengthen the risk management and I. Guidances improvement re-
thus provide a safe environment for drugs garding regenerative medicinal
usages as well as facilitate the development products
of the domestic pharmaceutical industry.
The “Regenerative Medicinal Products
Section 1 Management Act” (Draft) has been
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Enhanced the Drug regulations have also been submitted to the
Management Regulations Legislative Yuan for deliberation. TFDA
continues to announce the stipulation of
Introduction of the Policy relevant guidances on regenerative medicinal
products as a reference for the industry
In order to cope with the development GHYHORSLQJ UHJHQHUDWLYH PHGLFLQDO SURGXFWV
WUHQGV DURXQG WKH ZRUOG 7)'$ QRW RQO\ and further improving the regulatory
increases the accessibility of drugs for the environment.
37
