Page 46 - 2018食藥署年報(英文版)

services and delineate potential defects, allowing the applicants to prepare complete submission
package that fulfill review requirements, and thus facilitate review efficiency. TFDA also
announced review points of all types of new drug registration, which provides references for
the preparation of technical documents and helps increasing transparency of review, facilitating
submissions and expediting new drug approval.

Outcomes and Benefits

In total, TFDA processed 298 new applications for pharmaceutical clinical trials in 2017;
among them, 72% were multi-reginal and multi-center clinical trials (Figure 3-1). In addition, the
ratios of Phase I and Phase II clinical trial applications have shown increasing trends for the past
few years (Figure 3-2), indicating that the ability of related institutions in our country to conduct

clinical trials and their quality level are recognized internationally.
In order to continue enhancing our country’s competitive advantages in clinical trials
and to advance the research and development of new drugs, the Administration streamlined the
review procedure and review time efficiency for pharmaceutical clinical trial protocols. Three
“Advancement Measures for Pharmaceutical Clinical Trial Protocol Review Process” were
announced and enforced on August 10, 2017. The number of days required for processing the
applications and the overdue rate has both significantly dropped (Table 3-1).

Regarding the review of drug registration, TFDA announced the refuse-to-file mechanism
for applications of drug registration on January 1, 2017. Except for some applications that are
rejected due to incomplete submission package, rest of the other applications have been able to
enter the review process successfully. Ratio for the reviewed applications to total applications
are 84.3% in new drug registration and 68.3% in generic drug registration. The time needed for
repeated modifications of cases has been reduced and the time efficiency in the review of cases by
TFDA has been improved.
To facilitate the development of the pharmaceutical industry in Taiwan, TFDA provides
project consultation/counseling approach on medicinal products. As of the end of 2017, TFDA

has successfully assisted the registration of 5 new drug by providing consultation services.
Two of these new drugs, which are domestically developed new drugs, set new records as
been first approved new drug for certain indication in the world: one of the two “Global No.
1” product with ferric citrate was approved for CKD patients receiving hemodialysis to control
hyperphosphatemia; the other with liposomal irinotecan was approved for patients with metastatic
pancreatic cancer treated with chemotherapy (gemcitabine).

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