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A New Start for

Confidence in Food and Drugs Safety

The safety and quality of food, drugs and cosmetic products are closely entwined with our lives

and health. To initiate a chapter and era for food and drugs safety management and meet public

expectations and

Confidence in Food and Drugs Safety,

the Taiwan Food and Drugs Administration

(TFDA) has shouldered the crucial task of protecting public health and continued to build a

comprehensive and robust food and drugs safety management system.

This annual report has been specifically compiled so that every reader will be able to gain an

understanding of policy highlights and outcomes achieved in 2014.

Product management

has been

selected as the main theme of this annual report, which describes the implementation of relevant

regulations and policies governing food, medicinal products, controlled drugs, medical devices,

and cosmetics. We have also established a

supportive system

to demonstrate the product quality

assurance, factory management, logistics, monitoring, and border control. That includes risk

assessment management, technology developed results, national laboratories, inspection network,

international collaborations, risk communication, and consumer protection, hopefully, this annual

report will promote public cognition about the current status of Taiwan


s food and drugs management

policies and business. Additionally, this annual report contains a series of major events and general

statistical information for public reference and review.

Management and Regulatory Improvements, Optimization of Review Service

Capacity and Efficiency

To ensure the comprehensiveness of our country


s food safety and sanitation management system,

the TFDA twice revised food safety regulations in 2014. The

Act Governing Food Sanitation


formally revised to the

Act Governing Food Safety and Sanitation

which adopts the protection of

public food safety as its highest principle. Key amendments include thorough improvements to food

business registration, traceability, and three-level quality control with self-management responsibilities,

establishment of a Food Safety Office in the Executive Yuan, setting up a Food Safety Fund to increase

resource utilization, and large increases in the fines and penalties against food adulteration and

counterfeiting. 2014 is also marked as the first year of food business registration. Following promotional

efforts of all county and city health bureaus as well as support shown by various food businesses,

over 150,000 food businesses have been successfully registered nationwide as of 31 December 2014.

TFDA continued its border inspection of food products as well as post-market surveillance of residual

veterinary drugs and pesticides to thoroughly enforce and control food sanitation and safety.

TFDA also developed new food analysis and testing methods. In 2014, TFDA successfully developed

the world's first testing and identification methods for

tainted animal contents in oils and fats

as well


dimethyl yellow and diethyl yellow in food

. DNA barcode identification and inspection technology

for commercial fish and exclusive molecular biology testing methods for Dory Fish were established

as well. TFDA also strategically integrates resources from the private sector as well as all health

bureaus for work specialization, 154 private laboratories and 21 health bureau laboratories have been

certificated at the end of 2014 which can be able to carry out a total of 1,837 tests.

For improvements to the medicinal product review mechanism and advising of domestic pharmaceutical

manufacturers on alignment to international standards, TFDA established the

Professional Consultation

System for Pharmaceutical Projects

for new drug development in the country in 2014. A tangible

result under the system was the development of Nemonoxacin, a new chemical entity independently

developed and first approved in Taiwan with TFDA consultation. This achievement demonstrates