Page 78 - Taiwan Food and Drug Administration 2016 Annual Report

Taiwan Food and Drug Adminstration

(2) Management and Evaluation of Risk Management and Crisis Handling Measures
TFDA made regular reports on the implementation status of the risk management and crisis
handling program of 2015 to the Ministry of Health and Welfare task force and continues to
track program progress according to the Guidelines for Risk Management and Emergency
Response of the Ministry of Health and Welfare.
(3) Convening the Risk Management and Crisis Handling Management Review Meeting
The management review meeting was held on December 29, 2015 to review risk items listed by
various departments and agencies. Key public opinion incidents of the year, legislator inquiries, and
listed items were reviewed during the said meeting to con?rm key risk items for 2016.

2. Enhanced Crisis Response and Handling
(1) Response to Emergency Incidents
a. In response to the Formosa Fun Coast Dust Explosion, TFDA established the Inventory Data of
Burn Medication and Medical Supplies section on its of?cial website on June 29, 2015. Users
and visitors may peruse various information posted on this section such as instructions on the
donation procedure for medical supplies (medicinal products and sanitation supplies), contact
information for emergency purchases of controlled drugs, status on the supply of medicinal
products in hospitals, permit information of salves and topical applications, and drug reporting
counter. TFDA has purchased 700,000 square centimeters of skin tissue from other countries for
emergency use in various hospitals and initiate medicinal mobilization. The Formosa Fun Coast
Dust Explosion of Medical Supplies Allocation System were initiated on July 29, 2015. A total of
659 cases were successfully approved through Medical Resource Dispatch and Support System
for the Formosa Water Part Blast on July 29, 2015, which carried out the best possible results
and accelerated the supplies allocation of administration and management.

b. Due to major emergencies such as the Japanese Food Management Incident, and Tea with
residual agricultural chemicals Incident, TFDA has initiated its emergency response systems
and other measures that include tracking down of nonconforming products, product handling,
removal of products from store shelves for recall / destruction, revision of legal and management
systems, improving testing methods and lab capacities, handling of the press, and risk
communication.

(2) Revising Documents Related to Emergency Handling
a. To safeguard the dietary health of the general public, enhance food safety systems, build an
excellent and safe environment for food products, improve the performance for handling food
incidents, enforce event notification and implementation of emergency response measures,
TFDA revised the Management Manual for the Handling of Food-related Incidents by Central
Government Agencies (Level 1 Document) in 2015.

b. To enforce various standard operating procedures (SOP) such as conducting food event
investigations (and audits), handling of incident reports, establishing a hierarchical system,
publishing news articles, risk communication, analysis of public opinions, evaluation and
improvement, and follow-up inspection and controls, cross-departmental integration were carried
out as necessary. TFDA stipulated a total of four Level 2 Documents in 2015, namely (1) SOP for
the Handling of Food-related Incidents by Central Government Agencies, (2) SOP for Auditing
and Reporting of Food-related Incidents by Central Government Agencies or by Local Agencies,
(3) SOP for Hierarchical Noti?cation of Food-related Incidents by Central Government Agencies,
and (4) Manual for the Monitoring and Communication of Public Opinion in order to facilitate the
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