Page 74 - 2021 Taiwan Food and Drug Administration Annual Report
P. 74
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ducted counseling for 6 laboratories as well
I. Revised the regulations for reg- as 1 laboratory introduction session and 2
istration operations of precision WUDLQLQJ VHVVLRQV IRU LQGXVWU\ SUDFWLWLRQHUV
medicine molecular testing lab- so that the laboratories can have a better un-
oratory derstanding of the relevant regulations for
registration.
The Agency established the relevant
operating regulations for the registration IV. Registration operations
of precision medicine molecular testing
laboratories and began to perform related 6R IDU D WRWDO RI ODERUDWRULHV KDYH
tasks in 2019. In order to improve DSSOLHG IRU UHJLVWUDWLRQ DQG RI WKHP KDYH
PDQDJHPHQW SHUIRUPDQFH VHVVLRQ been reviewed and approved. The Agency
of inspector training and 2 sessions of will continue to handle the registration
review committee meetings were held operations to improve the testing quality
LQ WR GLVFXVV DQG FROOHFW RSLQLRQV of precision medicine molecular testing
UHYLVH DSSOLFDWLRQ JXLGHOLQH DQG RWKHU laboratories.
rules to make the registration review and
management practices more complete. V. Established the “Technical
Guidelines for the Application
II. Improved the follow-up man- of Next-generation Sequenc-
agement practices for registra- ing to the Detection of Inherit-
tion ed Diseases”
Pilot run of proficiency testing of preci- TFDA promoted the technical guideline
sion medicine molecular testing laboratory at the 2020 Bio Asia-Taiwan and published
started in 2020. 5 sessions of expert meet- it on the TFDA’s official website. Briefing
ings were held to discuss the pilot planning sessions for industry practitioners were
DQG DQDO\VLV RI WHVWLQJ UHVXOWV DQG UHOHYDQW held to facilitate the technical exchanges
information was collected. At the same between government agencies and domestic
WLPH LQIRUPDWLRQ V\VWHP ZDV HVWDEOLVKHG WR molecular diagnostics laboratories. A total
PDQDJH UHJLVWUDWLRQ FKDQJH H[WHQVLRQ DQG of 56 biotech companies and experts from
SUR¿FLHQF\ WHVWLQJ WKURXJK H PDQDJHPHQW WR clinical institutions actively participated
improve follow-up management. in the event to help improve the testing
quality of domestic laboratories to meet the
III. Conducted counseling and in- international standard.
troduction workshop
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