Page 58 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

B. Reporting Unintended Reactions of Food Consumption

In 2008, TFDA established the “National Reporting System for Unintended
Reactions of Health Food and Food in Capsule or Tablet Forms”, allowing
members of the public to report post-market safety data of unintended reactions
via the system. After members of TFDA Consultation Team for Unintended
Reactions of Health Food and Food in Capsule or Tablet Forms evaluate reported
cases and product safety, the Consultation Team will then immediately initiate
relevant measures to minimize potential hazards or contain the scope of the
incident. From 2008 to 2016, TFDA received a total of 192 reports of unintended
reactions of health foods or food in capsule or tablet forms, and monitored a total

of 1,590 food safety alerts.
C. Food poisoning statistics, prevention and control
There were 486 food poisoning outbreaks reported in 2016. The vehicles of
food poisoning outbreaks included compound cooking food and others, aquatic
products and its processed products, meats, eggs, dairy products and its processed
products, confectionery and candies, vegetables, fruits and its processed products.
Most frequent outbreaks were due to vehicles of compound cooking food and

others (Table 8 in Annex II for detailed statistics). To raise awareness of food
poisoning and prevent such outbreaks, TFDA established a specific webpage for
prevention of food poisioning and published Annual Report for Food Poisoning
and Prevention as a reference for relevant fields.

(2) Medicinal product quality management
A. The Reporting System of Medical Product Defects was established in 2004,
allowing healthcare professionals and the public to report medicinal products
with suspected defect. A total of 869 defective drug products were received

in 2016, of which recalls were initiated for 8 medicinal products. Meanwhile,
people can also use mobile device to report medicinal product defects .
B. Monitoring overseas medicinal products quality alerts on a daily basis to monitor
imports whether recalled in other countries. A total of 646 products were
monitored in 2016, among them, 4 medicinal products withdrew from overseas
had been imported in Taiwan. TFDA already asked the companies to recall these
products.

C. To ensure the quality of biologics, a total of 396 batches, 12,688,690 doses are
sealed for tests (Table 9 in Annex II for detailed statistics).

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