Page 128 - 2018食藥署年報(英文版)

Table 8 Important outcomes of food and drug testing technology in 2017

Category Outcomes Benefits
Food 1.Complete establishing testing methods for inorganic A total of 64 articles were
chemistry and arsenic and heavy metals such as Methylmercury in publicized in 2017, including
biology aquatic products, BPA in plastic infant feeding bottles, a sum of 998 items, which
labeling conformance of heat-tolerant plastic food upgrades the national food-
containers/packages, chlorite and chlorate in food, multiple related inspections, as
pesticide residues in poultry and livestock products well as helping the border
(including 123 items) and radionuclides in foods i nsp e cti on to pre ve nt
2.Establish a molecular biological method for rapid potential food safety issues
identification for fishes such as Haddock and Chilean and maintaining adequate
Seabass food quality and safety.
3.Complete the establishment of qualitative and quantitative
test methods for 4 new GMO items, as well as research
and development of a newly digital PCR technology for
GMO inspection
4.Establish a quantitative method for the Enterobacteriaceae
(hygiene indicator bacteria) and a test method for type A
rotavirus in shellfish and water body
Medicinal 1.Completion establish analytical method and mass 1. Appli ed to cli nical
products spectrometer database for 23 anti-inflammatory steroid pract ices suc h as
drug medicinal product s
2.Completion establish analytical method for steroid routine tests, clinical
preparation (include mirror isomer and impurities) determinations for drug
3.Complete establish 13 standards and spectrum database abuse and criminal
4.Use UPLC-Q-LIT and GC-MS to establish analytical identification
methods for 23 phenylethylamine and 34 synthetic 2. Establish standards and
cathinones in urine respectively spectrum database for
5.Establish LC-Q-TOF analytical methods for 55 drugs and comparing test results
complete 600 urine sample and meet the techniques
6.Development and application of traditional Chinese for drug abuse
medicine misuses and multi-component detection 3. Apply to Chinese
technology (Cistanche species medicinal herb and medicines identification,
preparations of clearing away heat and reducing fire) testing and quality
management
Biologics and 1. Establishing a second generation nationally standardized 1. The biological standard
emerging HCV genotype 1 viral nucleic acid and standardized work products can be used in
biotechnology items the quality management
medicinal 2. Establish the evaluation test mechanisms for the 3 of other relevant products
products biological agents: heparin products, enterovirus 71 vaccine prior and post-marketing,
and others as well as by the industry
3. Establish the data analysis platform for protein in product development
characteristics and function for monoclonal antibody drug and quality control.
Infliximab 2. The established analysis
4. Complete 11 articles for the foundation of Biological drug method can be used by
testing, organize the contents and publish a book on the marketing quality
“Biopharmaceutical test standard Ⅶ” control to ensure product
quality, as well as ensure
the safety of the public.
3. The biopharmaceutical
test standard can be used
as a reference in the
Chinese Pharmacopoeia
for specific test methods.

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