Page 54 - 2019食藥署年報(英文版)

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information, share experience, revised related guidance documents and map out future plans for
inspector training.

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"The 6 Joint Conference of Taiwan and Japan on Medical Products Regulation" was held
in Tokyo on October 11, 2018. Other than TFDA, National Health Insurance Administration of
Ministry of Health and Welfare, Center for Drug Evaluation, the representatives of the industries

and pharmaceutical and medical device related industry and associations also attended the
conference in Japan. The representatives from the official authorities and industries of both
countries gave speeches on topics ranging from the development and trend of drug regulations,
the practical management of Real-World Data, promotion policy of OTC, the management model
for the 3D printing of medical devices and the international regulatory harmonization strategies.

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Becoming an ICH member is a major achievement of Taiwan’s efforts on stipulating
international drug management regulations in the past few years, and it is also best proof that
Taiwan’s drug management regulations meet the international standards. TFDA has continued to
expand its participation in ICH related activities
(Figure 3-3). So far, more than 30 experts have
been selected to participate in more than 20 expert
working groups in the development of guidelines,

and vigorously contributed their strength. At
the same time, a working group of industry,
government and academia was formed in Taiwan 'JHVSF cc" HSPVQ QIPUP PG *$)
to understand the actual needs of industrial FWFOU QBSUJDJQBOUT
upgrading, and handled the guidance training and actively implements ICH guidelines, so that
ICH guidelines can be implemented in Taiwan’s pharmaceutical industry earlier and more
effectively.

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A total of 62 trainees from 14 APEC member economies participated in the seminar, and
the overall satisfaction score of the trainees was 4.35 (out of 5). All the participating economies
valued the importance of Good Registration Management (GRM). After the workshop, many
representatives from different economies consulted TFDA for the assistance of providing
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