Page 43 - 2018食藥署年報(英文版)

Refinement and

03 Improvement of Drug Safety

To complete the national drug management system and promote drug administration that in
line with international provisions, TFDA has established corresponding regulations in accordance
with International Conference on Harmonization (ICH) and World Health Organization (WHO)
to gradually perfect the management system in Taiwan. As the quality requirements of post-
marketing medicinal products by international laws and regulations are becoming more stringent
every year, corresponding provisions in Taiwan are in need of keeping up with the updates.
TFDA thereby reviews existing regulations and revises accordingly and establishes novel rules

for drug management following the global trends in advance therapeutic products regulations.
Moreover, to ensure the consistency of quality, safety and effectiveness of drugs, TFDA optimized
the drug review system and set up registration/post-approval management scheme for medicinal
products with high-risks or targeting specific populations. Meanwhile, TFDA actively works
on international collaboration and participate and international activities to reach regulatory
convergence and take part in global standard harmonization.

Section 1 Advancement and Consultation of Drug
Review System

Origin of Policy

To facilitate the accessibility of new drugs and support the development of domestic
biomedical/biotechnology industry, TFDA has optimized measures for clinical trial protocol
reviews, which include established the expedited review track for regenerative medicinal products
clinical trials, refined the review process of clinical trial protocol amendments and created a
comprehensive regulatory consultation network/project counseling system to help applicants

to prepare complete submission package, and thus accelerate new drug development as well
as reducing relevant costs. In addition, TFDA continues advancing the review process of drug
registration, implementing the refuse-to-file (RTF) policy for new drug registration, and promoting
the online review and application platform (ExPRESS) to facilitate correct document submission
and shorten the review/approval process.

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