67 / 132
2015 Annual Report
67
Risk Assessment
Management and
Research Outcomes
Cosmetics
Management
Appendix
National
Laboratory and
Testing Network
Risk Communication
and Consumer
Protection
International
Cooperation and
Cross-Strait Exchange
Food
Management
Medicinal
Products
Management
Policy and
Organization
Controlled
Drugs
Management
Medical
Devices
Management
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
and
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.