Page 90 - 2019食藥署年報(英文版)

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In order to understand the current operation of laboratories performing molecular testing
and evaluate the feasibility of the drafted guidance, TFDA worked with ten laboratories in
Taiwan to simulate the inspection and guide the laboratory development. The experience and
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guidance and optimize the inspection operations.
After several expert conferences, public information sessions, and inter-department

discussions, TFDA released the "Guidance on Laboratory Developed Tests and Services (LDTS)
for Precision Medicine Molecular Testing RQ 'HFHPEHU 7KLV JXLGDQFH GRFXPHQW
is intended to serve as a reference for domestic laboratories performing molecular testing to
improve their quality in testing and service. It is believed that this guidance document has set
a milestone for the precision medicine industry in Taiwan. The foundation of this guidance
is a well-balanced relationship between patient safety and development of the industry. It is
also harmonized with the ISO 15189 standard and can be used as a reference for laboratories
to establish their quality management system. The framework of the guidance is as shown in
Figure 5-5.

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On the basis of the "Guidance on Laboratory Developed Tests and Services (LDTS)
for Precision Medicine Molecular Testing," TFDA subsequently released several documents
including "Application Notes on the Registration of Laboratory for Precision Medicine
Molecular Testing," "Management Regulations of Laboratory for Precision Medicine Molecular
Testing" and "Review of Application for Registration of Laboratory for Precision Medicine
Molecular Testing and Operational Principles of Non-regular Inspections" to inform the
industry about the details of LDTS registration. These guidance documents, released step

by step, now form a comprehensive regulatory framework for LDTS for precision medicine
88
molecular testing in Taiwan.