Page 41 - 2020Taiwan Food and Drug Administration Annual Report

Advancement of Drug
03c

Management

In order to implement the life-cycle management of medicinal products and effectively
ensure the safety, efficacy, and quality of medicinal products, TFDA proactively improved
management regulations, joined international organizations, and builds a regulatory environment
that was in line with international standards. In the meantime, TFDA continue to improve
drug registration and review mechanisms, drug distribution practices, digital management,
quality and safety surveillances, and testing and analysis technology. Thus to strengthen drug

risk management and hence provide a safe environment for the public, as well as facilitate the
development of the domestic pharmaceutical industry.

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Introduction of the Policy
Introduction of the Polic
In order to increase the accessibility of drugs for the public, expedite the drug approval

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continues to establish a comprehensive drug management system by referring to the international
standards, trends in non-prescription drug management and patent linkage system. At the
same time cooperating with the current development status of the domestic pharmaceutical
industry. Moreover, TFDA continues to improve the relevant regulations to provide a better drug
regulatory environment for the public.

Implementation Strate
Implementation Strategy
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I. Improve the review mechanism for new drug registration
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drug approval, on November 18, 2019, TFDA announced the “Points to Consider on Drugs for
Pediatric or Rare Disease Designation” and the revision of the “Abbreviated Review Mechanism
for New Drug Applications,” “Priority Review Mechanism for New Drug Applications,”

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