Page 73 - 2021 Taiwan Food and Drug Administration Annual Report
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with the OCCLs. As a member of the to conventional medical information
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methods which were listed on the OCCLs OLIHVW\OH RI DQ LQGLYLGXDO RU VSHFL¿F JURXS
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were recognized around the world. Our active GLDJ QRVLV DQG W UHDW PHQW WK URXJK WKH
participation in the international organizations comparison and analysis of the human
establishes communication channels and genetic database. In view of the prosperous
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LQWHUQDWLRQDO YLVLELOLW\ DQG LQÀXHQFH TFDA conducted the listing management
for Laboratory Developed Test and Service
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testing laboratory to improve the testing
By continuously improving the testing quality.
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we introduced new analytical technologies to Implementation Strategy
establish test methods and comprehensively
improve the analytical techniques and To establish a management mechanism
standard to ensure the quality and safety of IRU WHVWLQJ TXDOLW\ 7)'$ SODQV WR FRQGXFW
products. Active participation in international documental review and on-site inspections
organizations and activities helps promote WKURXJK DQ LQVSHFWLRQ WHDP WR YHULI\ ZKHWKHU
exchanges in analytical techniques and learn or not the laboratory complies with relevant
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helping the country’s analytical techniques then it can be registered for management.
in line with the world’s standard. ,Q DGGLWLRQ WKH UHJLVWHUHG ODERUDWRULHV PXVW
undergo proficiency tests and aperiodic in-
Section 5 spections and they have to conduct extension
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Reinforced Laboratory oratories can be continuously monitored for
Management of Precision the quality of testing.
Medicine Molecular
Testing TFDA established technical guidelines
for molecular diagnostics techniques and
Introduction of the Policy diagnostics scope frequently used in the
domestic precision medicine molecular diag-
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the precision medicine not only refers reference by the laboratories.
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