Page 49 - 2020Taiwan Food and Drug Administration Annual Report

21, 2019. A total of 82 inspectors and experts from 20 countries participated in the conference,
including Britain, the United States, Germany, Italy, Canada, Japan, South Korea, and Southeast
Asian countries. The conference empowers all the inspectors from various countries to learn the
meaning and inspection skills the risk management of cross-contamination which emphasized by
the PIC/S GMP regulations.

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I. Contributed to ICH-related meetings
As an official regulatory member, we attended the meeting in Amsterdam, Netherlands,

and Singapore in 2019. Led by Director Wu, TFDA attended the meeting held in Amsterdam
(Figure 3-2) and Director Wu also served as the chairman of the sub-meeting, which is a
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groups, Taiwan’s expert representatives were selected to join 6 newly established working
groups in 2019, including design and conduct of clinical trials, analytical methods, post-
approval safety data management, and generic drug discussions. As of now, more than 30
experts have participated in more than 20 expert work groups which is a demonstration of our

actively contribution. At the same time, a working group consisted of experts from the industry,
government and academia was formed in Taiwan, to practically understand the needs of the
industry; and we conduct guidance training and actively implement ICH guidelines, so that these
guidelines can be effectively implemented in Taiwan’s pharmaceutical industry.

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