Page 50 - 2023 Taiwan Food and Drug Administration Annual Report
P. 50
2023 Taiwan Food and
Drug Administration
Annual Report
I. Involvement in ICH meeting- Regulation
related events
The 10th Joint Conference of Taiwan
To go with the new ICH procedure and Japan on Medical Products Regulation
for revising its technical guidance, TFDA took place on October 20, 2022 (Figure 3-1).
periodically attends its general assembly and The workshop was organized by the Japan
expert working group meetings, substantially MHLW/PMDA and TFDA through onsite
takes part and cooperates in the preparation and online meetings. Taiwanese and Japanese
of international regulatory harmonization, representatives gave presentations on the
continues to translate and define applicable regulatory progress of medicinal products,
guides to the safety, effectiveness, and the application of digital tools for clinical
quality of medicinal products, and holds trials, measures in response to COVID-19 and
ICH guidance-implementation industrial shared the implementation status of the MOU
educational training to help industries comply for the collaboration in medical device quality
with and keep track of the latest international management systems and regulatory updates
standards. on medical devices in Taiwan. In addition,
upon the 10th anniversary of the Joint meeting,
II. Organization of 2022 APEC both parties retrospected the achievements
Workshop over the 10 years and the future prospects.
The “2022 APEC Good Registration IV. Continue to participate in
Management Regulatory Science Center of the PIC/S activities
Excellence Workshop (GRM CoE)” was held
from August 15 through September 15, 2022. As a Participating Authority of
The current workshop took place through PIC/S, TFDA has sent representatives to
digital courses along with online meetings various sub-committees to actively engage
to train science professionals on laws and in the organization's affairs; TFDA also
regulations in APEC economies and to jointly involve to participate in expert circles and
and continuously promote and consolidate working groups dedicated to discussions on
GRM beliefs in the APEC region through the the revision of GMP and GDP regulations and
trained seed teachers for enhanced overall standards, in collaboration with international
quality and efficiency in medicinal review. experts. In 2022, TFDA participated in several
meetings and events, including the “2022 PIC/
III. Attendance in 10th Joint S Committee Meeting & Annual Seminar”
Conference of Taiwan and and “PIC/S Training Event and Meeting of the
Japan on Medical Products Expert Circle on Quality Risk Management
(QRM)”.
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