Page 53 - 2023 Taiwan Food and Drug Administration Annual Report

3Advancement of Drug
with the objective of aligning Taiwan's
GMP management system with international
standards.
Section 5
Improve Drug
Quality Inspection
Technology
▍ Introduction of the Policy
In response to the international drug
safety report of the possible presence
of the derivative, N-nitroso salbutamol,
in salbutamol-based asthma drugs, as
nitrosamines can be mutagenic, for the sake of
protecting medication quality and safety, TFDA
developed the test method within the shortest
time possible for respective parties’ reference
and adoption. In addition, in light of the fact
that emerging biomedicine products such as
virus-vectored vaccines are current trends in
medicinal research and development and safety
concerns such as gene sequence variance may
be present in the complex process, it is urgent
to define key test methods for the quality of
the said products and to introduce international in the viral nucleic acid sequence, effectively
novel test technologies reflective of the
international development trend for enhanced
control over the quality risk of emerging
biotech medicinal products in our country.
▍ Implementation Strategy
Management
I. Introduction of diversified
new technology for the
testing of medicinal products
Reflection of the nature of the compound,
TFDA applies liquid chromatography-tandem
mass spectrometry (LC-MS/MS) in the
establishment of quick, sensitive, and accurate
analytical methods through simple pre-
treatment of samples.
II. Leading in novel
technologies for the quality
test of emerging vaccines
TFDA introduces novel test technologies
of international interest that are highly
sensitive and feature complete sequencing
capacity - next-generation sequencing
(NGS), to develop test methods for sequence
identification and sequence variance analysis
within an automatic analytical process. These
methods were verified with the reference
viral substances produced by the UK National
Institute for Biological Standards and Control
(NIBSC); it was successfully proven that the
technology is capable of analyzing variations
enhancing test accuracy and credibility.
▍ Achievements and Benefits
The recommended methods for
testing N-nitroso Salbutamol in the active
pharmaceutical ingredient salbutamol
(including their English versions) were
released and made available to all parties
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