Page 79 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

conduct of emergency response after food-related incidents, achieve adequate knowledge of
the overall incident, and implement subsequent handling.
c. For the handling, reporting, and responding to emergency incidents related to food and drugs
safety, TFDA stipulated the Procedures for Initiating Emergency Response for Level 1 and Level 2
Food Incidents (Level 3 document) and Food, Medicine, and Cosmetics Incidents of Procedures
for Initiating Internal Emergency Response in TFDA for Level 3 Incidents (Level 3 document) to
achieve the goals of facilitating the rapid handling of emergency situations, eliminating public
concerns, and safeguarding the health of fellow citizens.
d. To support the contents of the Management Manual for the Handling of Food-related Incidents by Part II - Key Administrative Results Risk Assessment and Management
Central Government Agencies, TFDA organized the Exercise for Emergency Response to Food
Incidents on December 1, 2015 to implement document veri?cation and rolling revisions.

3. Post-marketing Surveillance System
(1) To monitor the quality and safety of products sold on the market, TFDA has continued to
implement post-marketing surveillance (PMS) that involve sampling and testing of marketed
products that pose higher risks, have the potential to affect the health of speci?c groups of
the population, are considered key daily necessities, or are targets of domestic and global
concerns. Results of surveillance activities or cause analysis from the previous year or earlier
periods shall be referenced in order to formulate the PMS plan.

(2) In 2015, a total of 19 PMS plans were implemented, including 11 for food products, three for
medicinal products, two for medical devices, and three for cosmetics. Nonconforming rates
for food products as well as drugs and cosmetics were 8.4% and 0.6% respectively. Cases
of nonconforming products were transferred to the responsible local health bureaus and
departments to pursue subsequent legal actions. Consultation was provided to encourage
companies to achieve improvement. Where necessary, relevant information shall be released
in order to safeguard consumer safety.

a. TFDA has continued to carry out sampling checks and monitor cases of food adulteration,
genetically modi?ed (GM) foods, heavy metal contamination of rice and aquacultural products,
mycotoxins and residual veterinary drugs in food, heavy metals in vegetables and fruits, and
residual pesticides in rice. A total of 5,327 specimens were examined, with a nonconforming rate
of 8.4%. TFDA shall continue to carry out monitoring and surveillance activities, and strengthen
testing for high risk food products. Results of these activities shall be used as an input for overall
assessments and reviews of food safety and health management in Taiwan.
b. Risk-based sampling and testing for Medicinal Product Surveillance.
In 2015, the drugs of allopurinol (gout medication), lorazepam (antidepressant), prednisolone
(steroid), cephalexin (antibiotic), nalidixic acid (antibiotic), valoproic acid (antiepileptic drug),
and steroid-based eye drops were sampled and tested. A total of 172 samples were all complied
with the speci?cation.
c. ADR reports and alerts were referenced to target medical devices with high levels of potential
risks and hazards, including them as items that require active monitoring in the annual medical
device quality surveillance program. In 2015, a total of 46 items were monitored. Results
indicated that every item has conformed to quality surveillance requirements.
d. PMS activities such as quality surveillance and joint audits were carried out for cosmetics sold on
the market (those claiming to have hair dyeing and anti-sunburn functions). A total of 242 cases
of quality testing and 2,200 cases of labeling audits were carried out for a conforming rate of
77
97% and 96.3% respectively.