Page 48 - 2020Taiwan Food and Drug Administration Annual Report

Implementation Strategy
Implementation Strate gy
I. Continued to extensively participate in ICH related meetings
th
Taiwan had become the 10 ICH pharmaceutical regulatory member in June 2018. It
is a major achievement of Taiwan’s efforts on stipulating international drug management
regulations in the past few years and it is also the best proof of that Taiwan’s drug management
regulations meet the international standards. After becoming a member of ICH, TFDA continues

to extensively attend the ICH Assemblies, participate in the working group to collaboratively
stipulate the global drug technical guidelines; moreover, TFDA organized relevant training to
assist the domestic pharmaceutical industry to carry out the ICH related standards.

II. Hosted APEC seminar in 2019
7R SURPRWH WKH TXDOLW\ DQG HI¿FLHQF\ LPSURYHPHQW RI SKDUPDFHXWLFDO UHJLVWUDWLRQ LQ WKH
APEC region and enhance regional regulatory convergence, TFDA held a three-day “2019
APEC Good Registration Management Regulatory Science Center of Excellence Workshop
(GRM CoE)” from September 17 to 19, 2019, to discuss the implementation of the principles
of good registration management of drugs in drug life-cycle management such as the pre-
application consideration, preparation of application dossiers, review mechanisms of various

countries and post-market safety management of drugs.
th
III. Conducted the 7 Joint Conference of Taiwan and Japan on Medical
Products Regulation
th
To promote cooperation between Taiwan and Japan, TFDA hosted the 7 Joint Conference
of Taiwan and Japan on Medical Products Regulation on October 1, 2019. It was organized by
TFDA and the Center for Drug Evaluation, the Ministry of Health, Labor and Welfare of Japan
and Pharmaceuticals and Medical Devices Agency (MHLW/PMDA) and the pharmaceutical
and medical devices industries from Taiwan and Japan participated in this conference. In the
conference, both Taiwan and Japan shared the latest information regarding the pharmaceutical
regulations, precision medicine and regulations for in vitro diagnostic devices, ICH E17,
e-labeling and promotion policies of indicator drugs. Furthermore, an official closed-door

meeting was held on October 2 in the same year, to further discuss the cooperation of drug
review and relevant experience sharing.
st
IV. Strived to host the 1 PIC/S Expert Circle Meeting on Control of Cross
Contamination in Shared Facilities
In view of the fact that cross-contamination in the shared pharmaceutical facilities will
affect the quality of drugs products, the PIC/S organization established the “Expert Circle
Meeting on Control of Cross Contamination in Shared Facilities” in 2017. Taiwan actively
VWULYHV WR KRVW WKH ¿UVW H[SHUW FLUFOH PHHWLQJ LQ 7DLSHL 7KH FRQIHUHQFH ZDV KHOG IURP -XQH WR

46