Page 68 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

and tests for accidents. For example, the determination of glyphosate in oat products and

benzene in oil products, false labeling of lutein in capsules or tablets or clarification of
suspected carcinogens in drip bag coffee.
(2) Provide administrative assistance: Including tests delivered by the prosecution, police,
investigation, justice or custom departments and technical support by local health
bureaus. For example, food poisoning due to consumption of toxic mushrooms and
suspension of flyblown chicken legs in lunch boxes for students in elementary schools.

2. The establishment and promotion of test methods

To respond to test requirements, TFDA establishes fast and reliable methods, details
are described in the following:
(1) Add and revise 22 announced test methods for food products (a total of 205 items),
including “Test method for food antioxidants – Multiple analysis” and “Test method
for pesticide residues in avian and livestock food – Multiple analysis for residues”;
38 recommended test methods for food products (a total of 57 items), including “Test
methods for veterinary drug residues in honey bees – Test for nitrofuran metabolites”
and “Test methods for iodine contents in food products”; 8 recommended test

methods for cosmetics (a total of 73 items), including “Test methods for hair dyes
in cosmetics (II)” and “Diameter measurement of titanium dioxide microparticles in
cosmetics”.
(2) Establish “Guideline on Minimum Requirements for Biological Products (VI)”
(Figure 5-1), including addition and revision of 9 items such as “Methylpentoses
in Polysaccharide Vaccines” etc.,” and the host of “Orientations of Guideline
on Minimum Requirements for Biological Products”, to facilitate mutual

communications with businesses industry.
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(3) Publish “Chinese Pharmacopoeia 8 ed.” (Figure 5-2) to align with the regulations of three
major pharmacopoeias in the world, namely USP, EP and JP. The Chinese pharmacopoeia
st
(Ch.P.) includes the 1 self-developed and patented API (Nemonoxacin Malate) and
additional 4 self-developed and produced API (Calcitriol, Docetaxel, Duloxetine,
Gemcitabine hydrochloride). The inclusion of new drugs developed in Taiwan facilitates
the transformation and upgrading of medical and pharmaceutical industries.

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