Page 47 - 2023 Taiwan Food and Drug Administration Annual Report
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3Advancement of Drug
Management
III. Advancement of the the application for bioavailability and
traceability and tracking bioequivalence studies, bridging studies, and
mechanism for medicinal clinical trials could be submitted online. This
products service has been available since January 1,
2023.
Pay close attention to the use of NHI-
covered medicinal products. Screen and II. Enhanced drug safety
modify items subject to a declaration of surveillance and analysis
medicinal products in the category of high
interest on a rolling basis. Perform cross-check Throughout 2022, there were a total
statistical analyses of medicinal products in of 13,339 adverse drug reactions reported
respective categories. Provide spontaneous domestically, 97 domestic and international
warnings on abnormal whereabouts of drug safety warnings, 45 safety warnings
medicinal products and cooperate with the on COVID-19 vaccines, and 49 drug safety
local public health bureau during site visits in assessments; 16 drug risk communication
order to ensure legitimate supply and avoid forms were released; and 4 quarterly
illegitimate circulation of medicinal products. publications containing short-text messages
In addition, by holding communication on the safety of medicinal products were
workshops, providing friendly assistance to issued; 708 suspicious quality defect events
businesses in the declaration of the traceability were reported; and 1,714 international
and tracking system for medicinal products, quality warnings on medicinal products were
and providing related advisory services to spontaneously monitored.
improve businesses’ compliance with the
declaration. III. Ensured legitimate supply
of medicinal products
▍ Achievements and Benefits
Three communication workshops on
I. Enhanced efficacy in the the declaration process of businesses and
review of medicinal products educational training of the public health
bureau were held throughout 2022 and were
Since 2022, TFDA has accepted eCTD participated in by a total of 316 people. In
submissions for the registration of medicinal addition, information on the raw material
products and a total of 9 cases were approved ephedrine of the controlled drug system has
through systematic verification, which been integrated into the Trace and Track system
further promotes the milestone of electronic for medicinal products, and the pre-warning
management of drug registration. Meanwhile, feature is created for the commissioning of
ephedrine in order to alert license holders
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