Page 94 - 2023 Taiwan Food and Drug Administration Annual Report

2023 Taiwan Food and
Drug Administration
Annual Report
data,” “self care therapy,” “cross-
regional clinical trials,” “regulations
on regenerative medicine,” “nano-
medicine drugs,” “regulations on unique
device identification (UDI),” “tumor
testing instruments for next-generation
sequencing,” “medical device
software,” “in-vitro diagnostic devices,” of the Implementation
“3D-printing devices,” and “artificial
intelligence instruments,” on order to
gradually deepen bilateral collaboration. and Tenth Anniversary
(II)2022 happened to mark the 10th
anniversary of Taiwan-Japan exchange.
In light of the far-reaching impacts of
COVID-19 on public health around
the world, both Taiwan and Japan have
realized the importance of international
collaboration and have prepared goals
and development blueprints for the next
10 to 15 years to be followed. Action
plans containing substantial items to be
worked on together are jointly discussed
and planned to be followed in future
exchanges. Meanwhile, continuous
efforts are being made in the promotion
of mutual exchange and deepening,
in enhancing medicinal management
and review capacity in Taiwan, and
in boosting harmonization between
regulations and those internationally
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for the increased international
competitiveness of the medicinal
industry in Taiwan.
Section 3
Fortieth Anniversary
of GMP for Western
Medicinal Products
of PIC/S Membership
▍ Introduction of the Policy
In order to ensure the medication safety
of the public, the GMP has been implemented
since 1982 in our country. It had been
upgraded to cGMP in 1995 (validation process)
and further upgraded to PIC/S GMP in line
with international norms since 2010. TFDA
become a member of PIC/S in 2013, and the
manufacturing quality of domestic medicinal
products has been upgraded to international
standards. The year 2022 coincides with the
40th anniversary of the implementation of GMP
for western medicinal products and the 10th