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2015 Annual Report


Risk Assessment

Management and

Research Outcomes





Laboratory and

Testing Network

Risk Communication

and Consumer



Cooperation and

Cross-Strait Exchange






Policy and









The growing complexity and diversity of engineering technologies in food, medicinal products, medical

devices and cosmetics make the managment and measurement of them more challenging than ever

before. TFDA continues to advance laboratory testing capabilities and estibilish fast, reliable, and

internationally harmonized methods in order to determin untargets, contingencies, and contaminants

which may hurt product qualities and public health. TFDA persistently strengthen the testing capacity

and quality of local health bureaus, and develop an efficient network of specialized test locations, to

improve local testing capabilities. Private laboratories were also accredited in order to support testing

required by government agencies, consumer associations, and manufacturers which need internal

quality control and export requirements. In response to product safety contingencies, the laboratory

network is mobilized to implement emergency inspections. Through the emergency response

mechanism, TFDA announces a list of private laboratories to the public for reference use, and helps the

manufacturers to perform voluntary management and testing from the source.

Section 1 Mission of the National Laboratory

Current Status

The National Laboratory is in charge of testing, formulating testing methods, conducting research and

investigations, supplying standards, and providing technical support and assistance to regional centers and

health bureaus for medicinal products, food products, and cosmetics in the country. TFDA aggressively

promotes the persistent development of the National Laboratory and launches into the perfection.

Policies and Outcomes

1. Improve Analysis Capabilities

(1) A total of four precision instruments and equipment were procured, namely the MALDI-TOF mass

spectrometer for microbial identification, a gas chromatograph equipped with tandem mass

spectrometer, a pyrolysis analyzer, and an elemental analyzer equipped with tandem isotope ratio

mass spectrometer. Technical documents were also composed for use by various fields.

(2) TFDA held three unknown material identification training sessions which were attended by 221

individuals. Course contents included applications of chromatography / mass spectroscopy in

food testing, techniques and practical applications of organic spectroscopy, and practical analytical

techniques for determining the authenticity of honey and its products.

2. Analysis Mission

(1) Basic Testing: Registration testing for medical devices, cosmetics, health food, special nutrition

supplements, and food additives; lot release for biologics (detailed statistics are provided in

Appendix 1 Annex Table 14); as well as testing for emergency eventing. A total of 3,460 tests have

been carried out.

(2) Cooperative Testing: TFDA provides testing support for the local health bureaus to test the

auditing and sampling specimens which the agency is incapable of testing independently,

consumer complaints, and complex food poisoning incidents. These include tests for cosmetics,

illegal medical products, and testing for the presence of pharmaceutical adulterants in prescription

Chinese herbal medicines or food products. A total of 2,275 tests were carried out, which

identified 501 nonconformities or tested positive for pharmaceutical ingredients.

National Laboratory and Testing Network