Page 104 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

(2) Medicinal products
TFDA has long-term participated in Regulatory Harmonization Steering Committee
(RHSC) of Life Science Innovation Forum (LSIF) under Asia-Pacific Economic
Cooperation (APEC). In February 2016, the APEC Regulatory Harmonization Steering
Committee (RHSC) endorsed the Roadmap to promote Good Registration Management
jointly proposed by Taiwanese and Japanese Governments and “Good Registration
Management Center of Excellence Pilot workshop” in Taiwan. The “Good Submission
Practice (GSubP) Guideline for Applications” developed by Asia Partnership Conference
of Pharmaceutical Associations (APAC) in cooperation with TFDA was endorsed by the
RHSC as one of the APEC guidelines in April 2016.

(3) Medical devices
A. Taiwan is one of the founding members of the Asian Harmonization Working
Party (AHWP). TFDA official has long-term served as the Chair of In Vitro
Diagnostic Devices Work Group (WG2 - Premarket: IVDD) for the AHWP
technical committee and led the development of in vitro diagnostic medical
devices (IVDs) international guidance documents endorsed as AHWP official

documents. During 2016, TFDA completed 4 AHWP endorsed guidances.
Moreover, the International Standard Organization / Technical Committee 212
(ISO/TC 212) also agreed on having a TFDA staff person to become member of
the expert committee of work group 3 for TFDA to continue participating in the
establishment of relevant standards.
B. Attend the 9 “International Medical Device Regulators Forum (IMDRF)” annual
th
meeting in Brasilia, Brazil from March 5 to 12, 2016 and a workshop on medical
software by “Global Diagnostic Imaging, Healthcare IT & Radiation Therapy
Trade Association (DITTA)” to remain updated on the latest regulatory trends.

C. Attend “The 21 Asian Harmonization Working Party (AHWP) Annual Meeting”
st
in the Philippines from November 20 to 26, 2016 to participate in important
decision making, give an update on the latest progress and future plans in IVDD
Work Group (led by Taiwan) and discuss matters with regulatory representatives
from New Southbound countries.

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