Page 106 - 2023 Taiwan Food and Drug Administration Annual Report

2023 Taiwan Food and
Drug Administration

Annual Report

Sep September 14 The Engineering Audit Group of the Ministry of Health and Welfare visited
TFDA for the maintenance and management of the “MOHW Controlled
Drug Manufacturing Premises Construction and Renovation Project”. The
project consisted of the maintenance of the management system and the
maintenance of operational quality and documentation; the total score
was 90, an excellent rating.

September 15 TFDA held the “2022 APEC Good Registration Management (GRM)
Regulatory Science Center of Excellence (CoE) Workshop”. More than
100 regulatory sciences experts from industries, regulatory authorities,
and the academia among 12 APEC economies participated the workshop.

September 27 The “Promotional Briefing for Domestically Manufactured Medical Device
for Domestic Use” was held to introduce high-quality domestically
Oct manufactured medical devices (including medical devices for hematology,
internal medicine, surgery, and artificial intelligence-assisted diagnostics)
to healthcare facilities and medical device businesses. Around 200 people
attended the briefing.

October 3-7 TFDA Inspectorate deploys personnel to attend the Committee
Meetings and Annual Seminars of the Pharmaceutical Inspection Co-
operation Scheme (PIC/S). This enables us to remain stay updated
on the latest GMP standards and regulations, engage in discussions
with representatives from member countries regarding international
cooperation, delve into the latest trends and challenges within
pharmaceutical inspections, acquire professional knowledge and
inspection techniques, and incorporate this information to bolster the
knowledge and capabilities of our inspection units.

October 18 The “2022 U.S.-Taiwan Web Conference on Controlled Drugs” was held
through online video conferencing and part of physical courses. US
DEA Supervisor Jennifer Jimenez, UCLA Professor Yih-Ing Hser, Chair
Professor Jhi-Joung Wang from the Chi Mei Medical Center, Division
Director Chih-Peng Lin from the National Taiwan University Hospital,
Deputy Superintendent Chih-Cheng Chien from the Cathay General
Hospital, and Director Wei-Jen Chen from the National Health Research
Institutes were invited to exchange with one another and share what they
knew about the management of controlled drugs in Taiwan and the US
and use of controlled drugs for medical purpose. The seminar attracted
more than a hundred attendees from related government agencies.

October 20-21 TFDA held the “10th Joint Conference of Taiwan and Japan on Medical
Products Regulation”. Representatives from Taiwan and Japan shared the
latest information of medical product regulations, digital tools for clinical
trials, measures in response to COVID-19, and updated medical devices
regulations. In addition, the 10th anniversary session was organized to
retrospect the achievements between Taiwan and Japan over the past 10
years.

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