Page 7 - 2023 Taiwan Food and Drug Administration Annual Report

management regulations are improved to continue safeguarding people’s health.
In pharmaceutical administration, TFDA continues to advance in e-management of the reviews of

medicinal products. Besides the reporting system that has been established, safety and quality information
on domestic and international medicinal products are being monitored. Meanwhile, commercial product
quality monitoring and manufacturer audits are conducted in order to strengthen the mechanism available
for the trace and track management of medicinal products and risk control over the quality and safety of
medicinal products. In addition, assistance was given to related pharmaceutical businesses in helping them
familiarize themselves with and consolidate Good Distribution Practice (GDP) requirements. As of the
end of 2022, 940 pharmaceutical dealers had obtained their GDP permits. Distribution management over
medicinal products has been gradually enforced to protect medication safety.

In addition, TFDA is proactively reflecting upon and amending applicable requirements in the
“Controlled Drugs Act”. Every year, a controlled drug audit project plan is formulated to strengthen the
inspection of the prescription rationality of controlled drugs and to prevent iatrogenic addiction or abuse.
Meanwhile, TFDA works with non-governmental organizations and other ministries and departments
in promoting the prevention of and education on substance abuse in diversified ways by reaching out to
workplaces, communities, aboriginal tribes, and online populations. TFDA collaborated with 12 NGOs
in total throughout 2022 and held a meme creation campaign to communicate to people how to prevent
substance abuse.

The “Medical Device Quality Management Application Platform” set up by TFDA was officially
launched on January 1, 2022. Medical device businesses can apply for inspections and track the status of
an application quickly through the e-platform. Moreover, TFDA has actively taken part in international
organizations in an effort to (1) help domestic medical device businesses enhance their international
competitiveness; (2) improve and optimize laws and regulations and related support mechanisms concerning
medical devices; (3) encourage multi-lateral cooperation on to create win-win situations for all parties.

In order to increase the familiarity of cosmetic businesses with the applicable requirements and to
successfully establish production information files, the amendment of the “Guidelines on the Establishment
of Cosmetic Product Information File” was announced in 2022. Moreover, in order to protect children’s
health and avoid mistaking cosmetics for food, the amendment of the “Guidelines for Safety of Children
Cosmetics” was announced; this would protect the health and safety of children in the use of cosmetics.

What is worth mentioning is that 2022 marked the 10th anniversary of the Joint meeting between
Taiwan and Japan, the 40th anniversary of Good Manufacturing Practice (GMP) for medicinal products,
and the 10th year of accession to PIC/S. Both Taiwan and Japan realize the importance of international
collaboration and hence are prepared to embark on action items and the development blueprint for
the coming 10 to 15 years. Meanwhile, TFDA will continue to work with the industry and boost the
professionalism of the pharmaceutical industry concurrently internationally with solid GMP as its
cornerstone so that the general public gets access to pharmaceutical products of the same quality as
advanced countries.

Given overall environmental changes, health, and safety concerning food, drugs, medicine, and
cosmetics will constantly be met with stern tests and challenges. For the sake of fulfilling its mission as a
“guardian of the public to ensure food and drug safety,” TFDA will cope with challenges in the future with
a forward-thinking approach by integrating ministries/departments, businesses, and consumers and also
connecting and working with international counterparts in a joint effort to build a comprehensive safety
protection network for the four major types of products in our country.

Director-General, Taiwan Food and Drug
Administration, Ministry of Health and Welfare