Page 81 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

Chapter 7. National Laboratory and Testing Network
The growing complexity and diversity of engineering technologies in foods, medicines, and
medical devices make the management and measurement of them more challenging than ever
before. TFDA continues to advance laboratory testing capabilities and estibilish fast, reliable, and
internationally harmonized methods in order to identify and categorize untargets, contingencies,
and contaminants which may hurt product qualities and public health.

Section 1. Mission of the National Laboratory
Current Status
The National Laboratory is in charge of testing, formulating testing methods, conducting
research and investigations, supplying standards, and providing technical support and assistance
to regional centers and health bureaus for medicinal products, food products, and cosmetics in Part II - Key Administrative Results National Laboratory and Testing Network
the country. TFDA aggressively promotes the persistent development of the National Laboratory
and launches into the perfection.
Policies and Outcomes

1. Testing of Major Food and Drugs Safety Incidents
(1) In April 2015, TFDA was responsible for handling the use of industrial-grade magnesium
carbonate, and handled 20 specimens submitted by local health bureaus and departments.
Quality testing of magnesium carbonate raw materials was carried out according to the
speci?cations and methodology described in the Chinese Pharmacopoeia or the Standards
for Specification, Scope, Application and Limitation of Food Additives. The case involved
three food items and 17 medicinal products. Test results showed that these specimens failed
to comply with Taiwan's specifications on magnesium carbonate as a food additive, while
nine out of the 17 medicinal products failed to comply with the speci?cations provided on the
Chinese Pharmacopoeia.

(2) In May 2015, TFDA handled suspected bacterial contamination of normal saline injections.
Relevant products in hospitals and production facilities were sampled and tested, and all were
found to be failed in sterility tests. The contaminant bacterial strain identified was Ralstonia
pickettii. Once test results were confirmed, TFDA immediately held a press conference to
explain the incident and recalled three types of medicinal products including 207 batches from
the affected production lines to prevent questionable products entering the market.

2. General Testing Activities
With growing requirements for the testing of food, drugs, and cosmetic products, TFDA actively
developed rapid and accurate testing methods. In 2015, 49,650 tests were carried out for 8,957
specimens. Details are described in the following:
(1) Basic testing: Registration testing for medical devices, cosmetics, health food, special nutrition
supplements, and food additives; lot release for biologics, as well as testing for emergency
eventing such as suspected use of industrial-grade magnesium carbonate and suspected
bacterial infection of normal saline injections.

(2) Cooperative testing: TFDA provides testing support for the local health bureaus to test the
auditing and sampling specimens which the agency is incapable of testing independently,
consumer complaints, and complex food poisoning incidents. These include testing for
poisoning due to ingestion of poisonous plants, suspected cases of Clostridium botulinum
poisoning, suspected cases Norovirus poisoning, adulteration of Chinese Medicine or foods
with modern pharmaceuticals, adulteration of food with illegal additives, and illegal drugs 79
(including electronic cigarettes).