Page 92 - 2023 Taiwan Food and Drug Administration Annual Report

2023 Taiwan Food and
Drug Administration
Annual Report
Section 2
The 10th
Anniversary on
Joint Conference of
Taiwan and Japan
on Medical Products
Regulation
▍ Introduction of the Policy
In order to advance the collaboration
between Taiwan and Japan on regulations of
medicinal products and medical devices, the
Taiwan-Japan Relations Association and the
Japan-Taiwan Exchange Association signed
the “Framework Agreement on Collaboration
between Taiwan and Japan” on November
5, 2013. Since then, the Joint Conference
of Taiwan and Japan on Medical Products
Regulation began under this collaboration
framework. Under the framework, TFDA,
Ministry of Health, Labour and Welfare
(MHLW) and the Pharmaceuticals and
Medical Devices Agency (PMDA) formed the
governmental working group that exchanges
the latest regulations on medicinal policies in ▍ Achievements and Benefits
Taiwan and Japan. The parties take turns each
year holding seminars on the bilateral side,
and 2022 is marked as the tenth anniversary.
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▍ Implementation Strategy
I. In order to expand the domains and levels
involved in the Taiwan-Japan collaboration
on medicinal products and medical
devices and to address globalization
trends in the medical field, TFDA holds
meetings with industries every year,
to help directly communicate between
regulatory authorities and industries, and
also provide ideas on governing regulations
or administrative measures, and discuss
further in the general assembly.
II. Taiwan and Japan exchange information
on regulations and review experiences
through official working groups such
as new drugs, generic drugs, good
clinical practice and good manufacturing
practice, non-prescription drugs, quality
management systems, product registration,
information exchange, mutual visits, and
observations and learning from each other,
and collaboration within the industry for
deepened substantial exchange.
I. Taiwan-Japan interaction
and developments in medical
field
(I) Taiwan and Japan formed the preliminary
framework for collaboration in the