Page 90 - 2023 Taiwan Food and Drug Administration Annual Report

2023 Taiwan Food and
Drug Administration
Annual Report
▍ Implementation Strategy
I. Real-time response to
pandemic changes to
expedite the procedure for
preparing national standards
TFDA managed to quickly prepare
and supply the first-generation SARS-
CoV-2 national standards within a year after
COVID-19 first broke out in 2020. As of
the end of 2022, it was already provided to
34 organizations. TFDA also assisted was
provided to 7 of them in obtaining emergency
use authorization (EUA). Such standards
were already recognized through the symbol
of national quality (SNQ) in 2021. Given the
quickly changing nature of the pandemic,
TFDA mobilized the standard preparation
team in real-time by expediting the preparation and applicable standards available around
of respective mainstream SARS-CoV-2 viral
strains within a year. TFDA applied the WHO
international standard preparation method
and whole genome sequencing made possible
with NGS to ensure genetic correctness.
Meanwhile, the virus inactivation results were
verified to ensure the safety of operators.
In addition, the NIBSC and 6 topnotch
laboratories throughout the nation were
invited to conduct the collaborative study; the antigen tests in order to provide qualified in
credibility and traceability of the standards
were boosted by concurrently using the same
international standards in the study.
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II. Maximized scope of the
application of standards as
quality control standards for
COVID-19 rapid antigen test
The Central Epidemic Command
Center (CECC) announced in May 2022
that a positive rapid test result would be
considered as a confirmed diagnosis, which
significantly drove up the demand for rapid
tests in the nation. TFDA initiated the auditing
of commercial rapid self-tests in June 2022
and amended the “Regulations Governing
Border Inspection and Examination of
Imported Medical Devices” in July, with the
implementation of border inspections for
“COVID-19 rapid antigen tests”. Only those
qualified products will be released. There
were, however, no test methods, regulations,
the world yet. In order to ensure the accuracy
of rapid antigen tests, TFDA drafted and
published the test method for the “COVID-19
rapid antigen tests” in compliance with the
WHO guidance and guidelines announced
by competent health authorities in respective
countries. Two antigen standards (Wuhan
strain and Omicron strain) were prepared and
applied in quality control of COVID-19 rapid
vitro diagnostic devices to our compatriots.