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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








b. Convening Specialized Consultant Meetings to Assess and Propose Control Measures

(a) Bovine Spongiform Encephalopathy Expert Committee Consultation

In addition to meat product reviews, imported beef and beef products are required to go

through food safety and risk assessments for Bovine Spongiform Encephalopathy (BSE)

as well as reviews conducted by the BSE expert committee of TFDA. Any country that has

experienced BSE outbreaks and intends to export beef and beef products to Taiwan must

submit an application that includes epidemiological surveys and monitoring data of BSE

cases that have occurred in the country as well as preventive measures, risk assessments,

and other information for review. Other review procedures such as risk assessments and

on-site review are also conducted to ensure the safety of the country's beef products.

The expert committee must ensure the complete safety of the products and complete risk

communication before allowing the import of the said products. A total of 4 BSE expert

consultation meetings were convened in 2014.

(b) Food Sanitation, Safety and Nutrition Advisory Committee

The Food Sanitation, Safety and Nutrition Advisory Committee is composed of professionals and

academics from various fields providing consultation and recommendations for food sanitation,

safety and nutrition policies, surveys and research projects, various standards, scientific

and technological exchanges, and handling of major cases with reference value for revising

administrative and regulatory regulations. A total of one Food Sanitation, Safety and Nutrition

Advisory Committee was convened in 2014.

(3) Training Risk Assessment Professionals

From 2011 to 2014, TFDA offered training courses from the Joint Institute for Food Safety and Applied

Nutrition (JIFSAN) , established by the US FDA and the University of Maryland. Professionals and

academics from Taiwan and other countries were also invited to provide lectures to gradually improve

the technological capacity for improving Taiwan's food risk assessment technology and alignment

with international standards. In 2014, two food safety risk assessment professionals from other

countries were invited to Taiwan for academic exchange, namely Dr. Lihan Huang of the United States

Department of Agriculture's Eastern Research Center and Dr. Jørgen Schlundt from the National Food

Institute of the Technical University of Denmark TFDA also held a total of five training courses on food

safety and risk assessment principles and methods which were attended by 802 individuals. Two

conferences were also held to exchange information with overseas academicians.

2. Medicinal Product Safety Risk Assessments

(1) Risk Identification and Data Collection

a. Adverse Drug Reactions (ADRs) Reporting System

The National Adverse Drug Reactions (ADRs) Reporting System


The National Drug Product

Defect Reporting System were

established in 1998 and 2004 respectively. In 2014, a total of

11,399 ADR reports and 845 defective product reports.

b. Monitoring International Alerts

Domestic and global medicinal product safety or quality alerts are monitored on a daily basis to

initiate investigations at once where necessary. In 2014, a total of 167 medicinal product safety

alerts and 656 medicinal product quality alerts were monitored.