Food and Drug Administration
(3) Training for Risk Assessment Professionals
To strengthen the awareness of industry firms about what should be performed in a cosmetic safety
assessment, TFDA held the
2014 EU cosmetics Product Information File (PIF) and Safety Assessment
conference in 2014. The main theme of its content program on safety assessment was the Cosmetic
Product Safety Report (CPSR), which was divided into safety information (product composition,
physiochemical properties, microbial content, impurities, toxicological properties of the ingredients, and
ingredient exposure) and objective evaluations (assessment factors that impact product safety such as
hazardous characteristics of the ingredients as well as local and systemic exposure assessments).
Section 2 Risk Management and Emergency Response Mechanism
To ensure adequate response to sudden emergencies, TFDA has continued to organize relevant
educational courses in order to improve risk management and emergency response concepts amongst
fellow colleagues. Information and news are collected and surveyed on a daily basis. Post-market
surveillance is also used regularly to ensure the safety of marketed products amongst the general public.
In case of emergencies, a response mechanism is also in place to quickly handle and contain issues to
prevent escalation. Daily surveillance and report of the emergency track progress in those cases. Once the
incident ends, improvement measures are formulated in order to improve risk handling capabilities.
Policies and Outcomes
1. Promotion and Control of the Organizational Risk Management Mechanism
(1) Education and Training for Risk Management and Emergency Response Mechanism
TFDA holds risk management and emergency response training courses every year, using actual
incidents in TFDA as lesson materials to strengthen overall concepts for risk identification and
emergency prevention amongst fellow colleagues. TFDA held four such training courses in 2014 which
were attended 258 individuals.
(2) Relevant Unit Management Assessment for Risk Management and Emergency Response
In order to follow up on the progress of risk management and emergency response plans of 2014,
TFDA regularly submits the management plans to the supervising task force in the Ministry of Health
and Welfare, in accordance with the
Guidelines for Risk Management and Emergency Response of
the Ministry of Health and Welfare.
(3) Management Review Meetings for Risk Management and Emergency Response
Management review meetings are held regularly on an annual basis to review risks listed by each
unit. Major public incidents, legislator inquiries, and past items mentioned in the given year are
referenced to determine the major risk items for 2015.
2. Enhance Emergency Response and Handling
(1) Responding to Emergencies
a. To report emergencies, initiate corresponding responses, and handle major emergencies, TFDA has
Emergency Response Manual
and relevant documents. Figure 7-1 details TFDA's
procedures for handling emergencies.