Page 83 - 2020Taiwan Food and Drug Administration Annual Report

the testing institution, management of certification and testing institutions, the procedures
of entrusted certification operations, management of entrusted certification agencies, and
DQQH[HV ZKLFK ZHUH RI¿FLDOO\ DQQRXQFHG RQ $XJXVW DV WKH EDVLV RI FRQGXFWLQJ UHODWHG
FHUWL¿FDWLRQ RI WHVWLQJ LQVWLWXWLRQV

$
$FKLHYHPHQWV DQG %HQH¿WVFKLHYHPHQWV DQG %HQH¿WV

By continuously improving the inspection and analysis capabilities in the laboratory, we
introduced new analytical technologies to establish test methods and comprehensively improve
the analytical techniques and standard to ensure the quality and safety of products. TFDA
aggressively facilitated the international interaction of analytical technology, to strengthen
the inspection and analysis capabilities to meet the international standards through interaction
and sharing of the global progress in analytical technology as well as challenges in the future.
In accordance with the “Regulations Governing Accreditation and Outsourced Accreditation
Management of Cosmetic Testing Institutions,” a total of 15 cosmetic inspection institutions
have been certified, with 51 certification inspection items, to strengthen the supervision and

management of inspection institutions and ensure the inspection quality.

4FDUJPO c-BCPSBUPSZ .BOBHFNFOU PG 1SFDJTJPO .FEJDJOF

.PMFDVMBS 5FTUJOH

y
Introduction of the Polic
Introduction of the Policy
Different from conventional medicine, the precision medicine not only refers to
conventional medical information but also information such as the genetic composition,

EDFNJURXQG HQYLURQPHQW DQG OLIHVW\OH RI DQ LQGLYLGXDO RU VSHFL¿F JURXS ,W LV DEOH WR VWLSXODWH
more accurate and personalized plans for disease prevention, diagnosis, and treatment through
the comparison and analysis of the human genetic database. In view of the prosperous
development of relevant service in medical, TFDA announced the “Guidance on Laboratory
Developed Tests and Services (LDTS) for precision medicine molecular testing” and conducted
the listing management of precision medicine molecular testing laboratory to improve the testing
quality.

gy
Implementation Strate
Implementation Strategy
To conduct the registration management of precision medicine molecular testing laboratory,
TFDA invited experts with expertise in pathology, medical inspection and molecular testing to

81