Page 90 - 2021 Taiwan Food and Drug Administration Annual Report

Appendix 1 Important Events

January January 20 to Participated in the Pharmaceuticals and Medical Devices
January 23 Agency (PMDA) - Asia Training Center (ATC) Multi-
Regional Clinical Trial Seminar “PMDA-ATC MRCT
February February 3 to Seminar 2020” in Tokyo, Japan, to learn about how
countries encourage the multi-regional clinical trials
February 6 to shorten the time taken for drug approval in different
regulatory agencies, and learn the specifications and
April April 8 review standards of various countries to promote the link
May May 8 between Taiwan’s MRCT and the world.
June June 15
Participated in “The 5th IABS Cell Therapy Conference”
June 15 organized by the International Alliance for Biological
June 16 Standardization (IABS) in Tokyo, Japan. The topic of the
conference was “Toward international convergence of
July July 24 basic technical requirements and evaluation of human
cell therapy products,” which was to understand the
trends of R&D technology and review management of
various countries and international organizations toward
cell therapy products.

Director-General Shou-Mei Wu accompanied President
Ing-Wen Tsai, Vice Premier Chi-Mai Chen, Mayor Wen-
Tsan Cheng of Taoyuan City and Deputy Minister Chi-
Kung Ho of the Ministry of Health and Welfare to visit “SCI
Pharmtech, Inc.” in Taoyuan.

Launched the “New Lifestyle Movement for Pandemic
Control” in collaboration with the Command Center to
encourage the public to have a new LOHAS attitude toward
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TFDA’s application for the APEC Medical Devices
Regulatory Science Center of Excellence (CoE) was
approved by the RHSC.

Participated in the teleconferences held by APEC Life
Science Innovation Forum-Regulatory Harmonization
Steering Committee and to discuss about the latest
development and future planning of the promotion of
“Good Registration Management.”

Held a virtual meeting on COVID-19 pandemic control
experience, and invited regulatory authorities such as
the USFDA, EMA, and PMDA to discuss topics such
as the drug supply chain, alcohol, personal protective
equipment, and diagnostic test kits.

Participated in the first workshop (online) of the “Trade
Facilitation through the Development of an APEC Food
Safety Risk Communication Framework” jointly organized
by the Food Standards Australia New Zealand and Asian
food industry practitioners. The workshop discussed
topics on how regulatory authorities handled food safety
risk communication framework. The Agency shared the
implementation results of food safety communication and
presented a short introductory video for the attendees.

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