Page 82 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

2. Accreditation of urine testing laboratories for identifying drug abuse

(1) As of the end of 2016, TFDA accredited 14 urine testing laboratories for identifying
drug abuse, of which 5, 3, 5, and 1 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
in 2016. Four round of routine proficiency tests of 56 accredited institutions were
carried out as well. As of the NCRs of on-site inspections and proficiency tests, the
accredited testing institutes must complete the improvement.

(3) In 2016, 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: When

the requirements of urine tests for emerging drug abuse proposed by Ministry
of Justice, TFDA may investigate the willingness of accredited testing institutes
and conduct on-site inspection based on the regulations of Article 24 in the “Act
governing certifications of testing and medical institutes for drug abuse urine tests.”
After confirmation TFDA will list the institutes as one of the recommended (not
accredited) laboratories and the list is available on the official website of TFDA.

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