Page 82 - Taiwan Food and Drug Administration 2016 Annual Report

Taiwan Food and Drug Adminstration

(3) Collaborative testing: Providing support for paid or commissioned tests as well as testing for
forensic purposes for illegal pharmaceutical products, controlled drug and narcotics, and
pharmaceutical adulterants in prescriptive Chinese herbal medicines and food products.

3. Formulating and Popularizing Testing Methods
(1) There were thirty-three Official methods announced, including Method of Test for Aflatoxin
B 1 in Cereal-based Foods for Infants and Methods of Test for Food Microorganisms-Test of
Cronobacter. There were forty-three recommended methods for foods, including Method of
Test for Dichloromethane Residue in Coffee and Method of Test for Chlorite in Noodles and six
recommended methods for cosmetics were published, including Method of Test for Hair Dyes
in Cosmetics and Method of Test for Material Identi?cation of Absorbable Surgical Sutures.

(2) TFDA compiled the Minimum Requirements for Biological Products V that added and revised
nine items such as glycoprotein and polysaccharide analysis and hosted a seminar to
introduce the Minimum Requirements for Biological Products and encourage bidirectional
exchange between the industry and competent authorities.

(3) TFDA held a meeting for the Chinese Pharmacopoeia Revision Committee (Figure 2-7-1) to
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publish the First Supplement to the 7 Version of the Chinese Pharmacopoeia, which incorporated
harmonized contents from the three major pharmacopoeia from the US, Europe, and Japan and
included Sterility Test, Microbiological Examination of Nonsterile Products, Bacterial Endotoxins Test,
and Total Protein. The purpose of the First Supplement was to align with international speci?cations,
establishing a milestone for the development the Chinese Pharmacopoeia.

Figure 2-7-1 Chinese Pharmacopoeia Revision Committee meeting

4. Preparation and Supply of Standard Specimen
Completed pilot collaborative study for national standard of HBV Genotype C viral nucleic acids.
TFDA also worked with the National Institute for Biological Standards and Control (NIBSC) of the UK.
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Standards prepared by TFDA were included in the collaborative study of the 4 WHO international
HBV standard. In addition to promote international collaboration, it is also helpful to the credibility
and visibility of national standards prepared by Taiwan. Such standards can be used by TFDA for
carrying out pre-market and post-market quality management, and may be supplied to the industry
for developing molecular diagnostic reagents and quality control.
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