Page 51 - 2019食藥署年報(英文版)

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TFDA has worked hard to promote international cooperation in pharmaceutical products
over the years. We actively participated in international organizations and strive to hold
international conference activities to strengthen Taiwan’s international participation and
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direction of implementations in 2018 are as follows:

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The International Council for Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH) is an international organization cofounded by the
pharmaceutical administration and the pharmaceutical industry of the European Union, Japan
and the United States in 1990. The Council aims to develop drug guidelines that can be accepted
by various countries and recognized as global technical standards through international
discussions in various regions. We hoped to join the ICH and participate in the stipulation of

international standards, avoid the technical regulation obstacles, and create opportunity of
cooperation amongst members, so that our domestic drug management regulations could meet
the international standards.

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To promote international information exchange and cooperation in drug management
and regulatory harmonization, TFDA has been long-term participating in the Regulatory
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Life Science Innovation Forum. TFDA co-champions the "Good Registration Management

(GRM)" priority work area with Ministry of Health, Labour and Welfare (MHLW) and the
Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. In addition, TFDA was
endorsed as an APEC Regulatory Science Training Center of Excellence in the area of GRM and
has been providing training each year in Taiwan. Through cooperation between the competent
authorities and the pharmaceutical industry, promoting GRM has been enhancing the mutual
trust between the competent authorities and the pharmaceutical industry and the regulatory
convergence amongst APEC member economies by 2020.

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