Page 40 - 2020Taiwan Food and Drug Administration Annual Report

Improve the review mechanism for
new drug registration Expanded the standards for indicator drugs

Announced the “Points to Consider on Drugs for Pediatric Announced and added the standards for “External
or Rare Disease Designation.” Hemorrhoid Preparations” and “Touch on (Spray)
Nasal Preparations.”
Revision of the The drug review standards have been revised to
“Abbreviated Review Mechanism for New Drug 18 categories with about 355 ingredients.
Applications,”
“Priority Review Mechanism for New Drug Applications,”
“Accelerated Approval Mechanism for New Drug
Applications,” and “Points to Consider for Breakthrough
Therapy Designation.”

Stipulated the patent linkage system of drugs

Added Chapter 4-1 “Patent linkage of Drugs” in the
Pharmaceutical Affairs Act.

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Reinforced the digitalization management
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Established a database of drug electronic labeling.g.
Expand the functions of the electronic submission
system for relevant applications, reviews, and
document management.
Promote the upgrade of i online submission and
review platform (ExPress).
Actively Participate in International
Events of Medicine
Continued to extensively participate in ICH related meetings.
Hosted APEC GRM CoE in 2019.
TFDA and Japan collaboratively completed the “New Drug Review
Scheme between MHLW/PMDA and TFDA/CDE “ in 2019.
Hosted the 1 PIC/S Expert Circle Meeting on Control of
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Cross Contamination in Shared Facilities.
Hosted the “2019 Taiwan-ASEAN Drug Regulatory Symposium.”