Page 89 - 2019食藥署年報(英文版)

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Precision medicine is one of the investments focuses of the global biomedical community.

In this area, a patient’s personal data obtained through diagnosis and biological testing (such as
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medical history of the family, etc.) are used to customize treatments for the patient by comparing
and analyzing the information with other entries within an established genomic database.
Precision medicine promises a future with maximized treatment effects, minimized adverse
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document, "Guidance on Laboratory Developed Tests and Services (LDTS) for Precision

Medicine Molecular Testing", to support the development of related industries in the nation. The
objectives of this guidance document include improving the quality of laboratories performing
such testing and promoting the development of molecular testing technology in Taiwan.

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TFDA initiated several research projects on the regulatory frameworks and trends of
laboratories conducting precision medicine molecular testing in the United States, China, the

European Union, Australia and Japan. Except for understanding the international practices,
TFDA also established an expert-based special task force to conduct six expert meetings and
three seminar sessions to explore the domestic needs in Taiwan. With a great honor, the TFDA
hosted the "international seminar on Laboratory Developed Tests and Services (LDTS) for
precision medicine molecular testing industry" and invited experts in molecular testing from the
US and China to share their regulatory and technical experience. The former Premier Lai Ching-
Te, as the Premier at that time, gave an opening speech at the international seminar, which gave a
strong signal that the government values the importance of precision medicine (Figure 5-4).

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