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Food and Drug Administration


(3) In 2014, TFDA convened the

Drug Abuse Urine Testing Institution Accreditation Review Committee

and On-Site Assessment Committee Meeting

, and the Conference for Drug Abuse Testing Techniques.

Main resolutions included: delaying additional and extension audits payment systems; one institution

was accredited; in the event that the testing institution needs to add a branch institution or office for

temporary storage of remaining urine samples, the said institution must first submit an application to

TFDA for review and verification before completing the registration.

3. Good Laboratory Practice (GLP) Accreditation for Non-Clinical Studies


Good Laboratory Practice (GLP) for non-clinical studies

is implemented in order to improve the

correctness and reliability of test data. The scope of GLP accreditation of TFDA includes the fields of

medicinal products, medical devices, health foods, and cosmetics, and covers various non-clinical

safety tests related to biological systems at various product research and development phases in the

aforementioned fields.

(2) In 2014, TFDA conducted and offered eight GLP audits and consultation, reaching a total of 17 GLP-

accredited laboratories with 14 in northern Taiwan and three in central Taiwan. Of these, 56 testing

items were accredited accordingly.

(3) In 2014, auditor training and business owner management seminars were also held in order

to introduce the latest information from other countries, align audit standards with international

specifications, and help business owners and relevant personnel understand GLP specifications and

industrial trends.

Section 4 Comprehensive Mobilization for Emergency Testing

Current Status

TFDA formulated the

Principles for Mobilizing Private Laboratories in Response to Emergencies

. To meet

testing requirements arising from emergencies, private laboratories with the relevant testing equipment

and capabilities may be mobilized to participate in testing work, allowing the emergency response

system to serve as the basis for post-market testing of products as well as self management and testing

by business owners.

Policies and Outcomes

1. Selection Principles for the List of Accredited Laboratories

Laboratories accredited for

specified tests and methods

or other accredited laboratories certified by

the Environmental Protection Administration (EPA) or Taiwan Accreditation Foundation (TAF).


Inspection Resource Database

of the TFDA is also used to survey private agencies equipped with

these testing instruments and invite these agencies to help carry out the specified tests.

2. Verifying Laboratory Testing Capabilities and Public Release of the List of

Accredited Laboratories

TFDA has provided laboratories with testing methods as the basis so that the laboratories would only

need to refer to the standard operation procedures (SOP) and maintain quality assurance documents

and relevant test records. Applicant laboratories that have been verified to have the necessary

testing techniques and independent quality control capacities are included in the list of accredited

laboratories, which is publicly released by the TFDA for reference by those intending to commission

testing services.