Page 32 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

(B) In 2016, new clinical trials and amendments applications in Taiwan totaled

309 and 3,297 cases respectively. These figures amounted to a near 3.7%
increase in the total number of cases compared to the previous year (new
applications and amendments are 346 and 3,130 cases).
(C) To safeguard the rights, safety and welfare of trial subjects and maintain the
quality of clinical trials, all clinical trials must be implemented in compliance
with the “Good Clinical Practice (GCP) Standards for Medicinal Products”.
A total of 41 GCP inspections were conducted in 2016.

C. Reforms to medicinal products review system

Due to the rapid changes and development in medical and pharmaceutical
industry, TFDA promotes revisions of new drug review process and timepoint
control to elevate the efficiency and transparency of medicinal product review
mechanism for businesses to estimate case review progress. At the same
time, TFDA promotes new drug RTF mechanisms, and assists businesses in
establishing capabilities of medicinal products registration to maximize limited
review capacities and resource of the review department. Additionally, TFDA

tries to provide “counseling services” to the applicants prior to their NDAs to
improve the quality of the documentaries.

(2) Promoting professional consultation for medicinal products projects
A. To support the “Taiwan Biotech Industries Take off Action Plan” of the Executive
Yuan, TFDA committed itself to facilitating new drug research and development,
and establish a “Professional Consultation System for Pharmaceutical Projects”
for pharmaceutical industry consultation. Items were evaluated and selected
according to the four selection indicators of “innovativeness”, “contribution”,

“early benefits” and “legal compliance” to facilitate new drug development
industry in Taiwan (Figure 2-6).
B. For new drugs ready for marketing or under development, TFDA revised and
promulgated “Counseling Directions on Medicinal Products Projects” on
December 12, 2016, added company counseling meeting mechanisms, actively
provided bilateral communication channels and helped businesses clarify doubts
on laws and regulations. TFDA also introduced and implemented module-base

rolling review to reduce the frequencies of requesting supplements during official
application and thus expedited the marketing of domestic new drugs as well as
satisfied the needs of medical care of the fellow citizens.

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