Page 46 - 2023 Taiwan Food and Drug Administration Annual Report

2023 Taiwan Food and
Drug Administration
Annual Report
Besides enforcing the “Patent Act” to
protect the patent holder, it is encouraged that products and risk control over the quality and
pharmaceutical companies engage themselves
in the research and development of design-
around by clarifying related concerns about
infringement prior to marketing taking
advantage of public and transparent patent
information so that marketed medicinal
products are not at risk of discontinuation
as a result of tort, undermining the right to
medication of patients. As of the end of 2022,
there had been 31 cases challenging design-
around and 14 permits had been issued.
Section 2
Reinforcement
of Drug Risk
Control and Digital
Management
▍ Introduction of the Policy
In order to promote drug administration
and to comply with the requirements of the
International Council for Harmonisation of
Technical Requirements for Pharmaceuticals
for Human Use (ICH) and other international
standards, TFDA continues to advance
electronic management over the review of
drugs, expedite operations, and improve
submission quality and protects medication
safety by enhancing the trace and track
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management mechanism for medicinal
safety of medicinal products.
▍ Implementation Strategy
I. Improving electronic
management for reviewing
medicinal products
The Electronic Common Technical
Document (eCTD) Platform was officially
launched on January 1, 2022. TFDA also
continues to strengthen and expand the
functions of the platform and provide more
diversified services to enhance the review
efficiency for medicinal products.
II. Reinforcement of drug
safety reassessment
Besides creating the reporting system,
TFDA spontaneously monitors information
about the safety or quality of medicinal
products domestically and internationally and
the quality of products available on the market
and audits manufacturing facilities. In cases
of safety issues or major quality abnormalities
of medicinal products, once found, safety re-
evaluation or quality investigation will be
embarked on. Meanwhile, the National Health
Insurance Research Database (NHIRD) will
be analyzed in order to know how clinical
medicinal products are used in the country and
such information will serve as a reference in
the assessment of risk control efficacy and in
the preparation of policies in the future.