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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

Current Status

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

formulated the

Emergency Response Manual

and relevant documents. Figure 7-1 details TFDA's

procedures for handling emergencies.