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Food and Drug Administration



Preparation and Supply of Biological Standards

were awarded with the

Symbol of National Quality

(SNQ) Award

and the

2014 National Biotechnology & Medical Care Quality Award

a. To support pre- and post-market quality management of

in vitro

diagnostic device (IVD) in Taiwan, TFDA

prepared the biological standards with highly professional and strict technology. Leading international

laboratories were also invited to participate in the collaborative study to ensure the quality and credibility

are aligned with those of the World Health Organization (WHO).

b. To promote the development of biomedical industry and the quality of clinical diagnostics, there were

some standards available in TFDA and continually provided to the blood centers, medical institutions,

and biotechnology companies for testing methods verification and

in vitro

diagnostic reagent


c. TFDA continually prepared the novel national biological standards with innovative and strict attitude

to assist the biomedical industry of Taiwan in global recognition. Consequently, TFDA has garnered

recognitions that include certification from the Institute for Biotechnology and Medicine Industry (IBMI),

acquired the Symbol of National Quality (SNQ) for biotech services in the field of biotechnology, and won

the Silver Award from the most prestigious

National Biotechnology & Medical Care Quality Award


8-2 and Figure 8-3).

Figure 8-2

Award ceremony for the 17


National Biotechnology & Medical Care Quality Award