Page 44 - 2020Taiwan Food and Drug Administration Annual Report

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Introduction of the Policy
Introduction of the Polic
With the advancement of international regulatory environment and digital management
of drugs, many countries have developed electronic systems for the applications of drug
registration, cross-platform compatibility, and drug information exchange. To align with
international standards, to promote international harmonization regarding the application of drug
registration, to expedite administrative process and increase the submission quality, as well as

facilitating drug information sharing and exchange, and enabling the public to easily obtain the
drug safety information, TFDA encouraged online applications of drug registration since 2018,
and planned to establish a database of electronic drug labeling since 2019.

Implementation Strate
Implementation Strategy
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I. Improved Taiwan's electronic submission system
TFDA continues to expand the functions of the electronic submission system for relevant
applications, reviews and document management in order to be in line with the digitization

of drug administration and in accordance with the regulations of the International Council
for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and
international standards, to reduce the administrative process for the applicants and enhance the
review efficiency and strengthen the function for document management in various types of
cases for review and inspection.

II. Reinforced the drug safety surveillance and analysis
TFDA continues to monitor and analyze drug safety through the post-market adverse drug
reaction reporting system and actively monitors the safety information about domestic and
foreign drugs in order to ensure the safety of the public’s drug use; we also utilize the nation’s
drug safety related database to monitor and analyze drug safety.

III. Established a database of drug electronic labeling and promote package
inserts for non-prescription drugs
TFDA plans to establish a database of drug electronic labeling taking the trend in

international electronic labeling of drugs as reference. The new system will have the drug
electronic labeling using computerized structure format rather than PDF files. It allows the

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