Page 35 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

(2) Clinical Trial Reviews

a. Reviews were conducted according to the Application Guidelines for the Clinical Trial of
Medicinal Products and Ethical Review for the Clinical Trial of Medicinal Products (Central IRB)
to ensure the comprehensiveness of documents submitted by the applicants and improve the
ef?ciency of case review processes.

b. In 2015, new clinical trials and change applications in Taiwan totaled 346 and 3,130 cases
respectively. These ?gures amounted to a near 21.5% increase in the total number of cases
compared to the previous year. Part II - Key Administrative Results Medicinal Products Management

c. To safeguard the rights and interests 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 52 GCP audits were completed in 2015.

(3) Reforms to Medicinal Product Review Systems
In 2015, revisions to the Priority Review System and Accelerated Approval Mechanism for
New Drug Applications were promulgated to expand the applicable scope of new drugs with
new chemical entity (NCE) to include other new drugs which are detined in Article 7 of the
Pharmaceutical Affairs Act (namely: NCE, new therapeutic compound, and new method of
administration). In order to improve the transparency of the review process, manufacturers
were invited to consultation meetings in order to improve the transparency of the review
process. TFDA also introduced bene?t and risk evaluation systems for new drug reviews and
initiated pilot for online new drug application systems in order to expedite the approval of
new drugs and achieve the vision of establishing advanced technologies in Taiwan to and
expanding global markets. Fifteen priority review cases were completed, with review time
greatly reduced to 171 days (median value).

3. Promoting Professional Consultation for Pharmaceutical Projects
(1) To support the Taiwan Biotech Industries Take off Action Plan of the Executive Yuan,
TFDA committed itself to improving pharmaceutical industry consultation and establish a
Professional Consultation System for Pharmaceutical Projects for new drugs being researched
and developed in Taiwan. Items were evaluated and selected according to the four selection
indicators of: (1) innovativeness; (2) contribution; (3) early benefits; (4) legal compliance.
Legal inquiries and consultation were provided from the research and development (R&D)
phase to ensure that drugs are released as early as possible for the patients and encourage
new drug R&D in Taiwan.

(2) From 2010 to the end of 2015, TFDA provided consultation to 32 projects, and approved a
novel new drug that was domestically produced in 2014. In 2015, another two novel and
domestically produced new drugs were approved as well, generating a new record for world
?rsts in Taiwan. Approved indications for these drugs were adult hemodialysis patients with
chronic kidney diseases and hyperphosphatemia (API name: Ferric Citrate) and metastatic
pancreatic cancer patients that previously received chemotherapy with gemcitabine (API
name: Irinotecan liposome).

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