Page 49 - 2021 Taiwan Food and Drug Administration Annual Report
P. 49
)LJXUH ZH ORRN IRUZDUG WR KDYLQJ impurities that may be generated during
more practical and in-depth exchanges with WKH GUXJ PDQXIDFWXULQJ SURFHVV DQG
countries on this platform. The efforts will develop recommended test methods to be
help us understand the implementation published on TFDA’s website for reference.
strategies and models adopted by various /DERUDWRULHV PD\ PRGLI\ PHWKRGV DV QHHGHG
countries to stabilize the supply chain of or establish their in-house methods after
medicines and pandemic control materials self-directed evaluation and verification to
and establish partnerships with other control product quality. TFDA also continued
countries to overcome the pandemic. to carry out risk assessments of nitrosamine
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Section 6 44 pharmaceutical ingredients that may
generate or contain NDMA risk were
Improvement of Drug LQLWLDOO\ VFUHHQHG DQG WKH LQGXVWU\ RSHUDWRUV
Quality Inspection were notified to prioritize assessment and
Technology inspection.
Introduction of the Policy Implementation Strategy
In response to various international I. Established a platform for
LQFLGHQWV RI DQWLK\SHUWHQVLYH GUXJV JDVWULF multi-residue analysis and de-
GUXJV DQG K\SRJO\FHPLF GUXJV VXVSHFWHG tection of nitrosamines for high-
of containing N-nitrosodimethylamine risk drugs
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7)'$ QRWL¿HG OLFHQVH KROGHUV WR SURDFWLYHO\ The national laboratory built a multi-
assess and inspect the risk of nitrosamine residue analysis platform with two
technologies: Ultra-high performance
Figure3-3 Online conference sharing experience on COVID-19 pandemic control
47
