Page 93 - 2023 Taiwan Food and Drug Administration Annual Report
P. 93
6Special Edition
review of new drugs in 2018 and have improving the manufacturing quality
collaborated in the review of two pilot of medical devices. The “Medical
cases, and mutually signed the “New Device Registration Scheme between
Drug Review Scheme between MHLW/ MHLW/PMDA and TFDA/CDE” was
PMDA and TFDA/CDE” in 2019, established jointly in 2021 in an effort
which marks an important milestone for to promote bilateral collaboration on
the mutual exchange and collaboration medical devices. In addition, the “FAQs
in medicinal products. Through the on Quality Management Systems for
substantial collaboration between Medical Devices between Taiwan and
Taiwan and Japan in the review of Japan” and the “FAQs on Registration
new drugs, we have completed 3 new of Medical Devices between Taiwan and
drug reviewsand expedited the new Japan” were prepared to help medical
drugs to the market. In addition, taking device industries in both countries
advantage of the bilateral collaboration familiarize themselves with regulatory
experience, Taiwan and Japan jointly requirements while marketing their
prepared the “FAQs on Taiwan-Japan products to the market as soon as
Collaboration on New Drugs” in 2022, possible. Statistics up to the “Tenth
which will help industries in both Joint Conference of Taiwan and Japan
Taiwan and Japan understand more on Medical Products Regulation” show
clearly the application procedure and a total of 44 Japanese manufacturers and
review mechanism available for the 67 Taiwanese manufacturers benefited
collaborative reviews of new drugs, from the implementation of QMS MOC.
contribute to transparent collaboration
procedures, and expedite the new drugs II. Gradual deepening of
to the market in both countries. collaboration in medical
(II)Since November 30, 2018, when field
Taiwan-Japan Relations Association
and the Japan-Taiwan Exchange (I) The parties continue to explore and
Association signed the “Taiwan-Japan exchange in related medical fields,
Medical Device Quality Management including issues such as “applicable
System Collaboration Memorandum” COVID-19 countermeasures,” “orphan
(QMS MOC), the parties have drugs,” “harmonization strategy for
officially committed themselves to regulations on medicinal products
in Taiwan and in Japan,” real-world
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