Page 91 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

(3) Exemption from Repeated Testing
In January 2015, TFDA recommended four testing agencies for the list of Class B public testing
agencies of exporting countries of the Ministry of Health, Labor and Welfare in Japan, and
successfully achieved exemption from border inspection sampling tests for Taiwan's food
exports to Japan, helping to accelerate customs clearance, reduce inspection fees, and reduce
commercial costs for food companies.

(4) Introducing Accelerated Accreditation Processes
On December 14, 2015, TFDA approved revisions to the List of Tests Not Requiring Measurement
Uncertainty Assessment Report for Food Testing Institutions Applying for Quantitative Test Part II - Key Administrative Results National Laboratory and Testing Network
Accreditation and updated applicable testing methods to encourage testing institutions to
apply for certification. In 2015, two laboratories and nine test items successfully completed
accelerated accreditation, providing an additional option and reference for border inspection
tests, administrative requirements, and commissioned testing for business requirements.

2. Accreditation of Urine Testing Laboratories for Identifying Drug Abuse
(1) As of the end of 2015, TFDA accredited 15 urine testing laboratories for identifying drug
abuse, of which six, three, ?ve, and one were distributed in northern, central, southern, and
eastern Taiwan respectively. Accredited tests for urine testing laboratories for identifying drug
abuse include 9 types of drugs, namely: morphine, codeine, methamphetamine, amphetamine,
MDMA, MDA, cannabis metabolites, ketamine, and norketamine.
(2) To ensure the quality of accredited urine tests for identifying drug abuse, TFDA conducted 15
routine audits and 6 unannounced audits of the accredited institutions. Four rounds of routine
pro?ciency tests of 58 accredited institutions were carried out as well.
(3) In 2015, TFDA held the Drug Abuse Urine Testing Institution Accreditation Review Committee
and On-Site Assessment Committee Meeting and the Conference for Drug Abuse Testing
Techniques to make the following resolutions: passing urine tests of 1 accredited testing
institution, and that the period for preserving urine samples that have tested positive shall be
determined by the contractual terms signed by the test commissioner and commissioned test
institution.
3. Good Laboratory Practice (GLP) Laboratory Accreditation for Non-clinical Studies
(1) TFDA implemented the GLP for Non-clinical Studies in order to improve the truthfulness and
reliability of test data. The scope of TFDA GLP accreditation includes the sectors of medicinal
products, medical devices, health foods, and cosmetics, as well as relevant non-clinical safety
tests for biological systems during the research and development (R&D) phase of the various
sectors.
(2) In 2015, TFDA completed GLP audits and consultations for 10 laboratories and accredited
15 GLP laboratories and 53 tests items, of which 13 and 2 laboratories were in northern and
central Taiwan respectively.
(3) In 2015, TFDA implemented auditor training and business management seminars, and
introduced the latest information from other countries to establish consistent auditing
standards. These activities helped businesses and responsible personnel gain a better
understanding of GLP speci?cations as well as trends in the industry.

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