Page 89 - 2023 Taiwan Food and Drug Administration Annual Report
P. 89
6
Special Edition
In 2022, TFDA welcomed multiple ▍ Introduction of the Policy
significant milestones. Besides coping with the
pandemic and quick preparation of national To support quality control over medicinal
standards by applying the many years of products and in-vitro diagnostic medical
experience and control over medicinal products devices during research and development, a
and medical devices, both the Taiwan-Japan total of 20 biological national standards have
Joint meeting and accession to PIC/S marked been made available since 2004. In the early
their tenth anniversary of gradually deepening days, most standards were meant as controls
international collaboration. The release of the for the quality of in vitro diagnostic reagents
JFDA and the implementation of GMP for used in routine blood tests of viruses. Each
medicinal products, on the other hand, reached standard usually takes 2 years to be prepared.
their 30th and 40th year, respectively. All the However, in response to the urgent nature
accomplishments are well received. of the pandemic and the need to support
businesses so that they could e fight against
Section 1 the pandemic. Therefore, TFDA strived to
shorten the time required to establish a new
New Prospects standard.
for the Biological
National Standard Given the quickly changing nature of
System the pandemic, TFDA prepares the mainstream
viral strain nucleic acid standards in real time
and maximizes the scope of the application. At
the same time, TFDA keeps close tabs on the
quality of rapid test kits is safeguarded. New
prospects for the application of standards are
explored and expanded.
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