Page 53 - 2018食藥署年報(英文版)

published in 2002, all drugs of rare disease-related information is summarized and collected from
paper-based information reported by medical institutes or pharmaceutical companies. In 2017,
TFDA initiated the online reporting system for drugs of rare disease to encourage and facilitate
relevant reports.

Section 6 APEC Good Registration Management Regulatory
Science Training Center of Excellence (CoE)

Origin of Policy

To facilitate international collaboration and regulatory convergence for medicinal product
management, the TFDA has become a regular participant in APEC Life Science Innovation
Forum and is actively involved in the work promoted under the Regulatory Harmonization
Steering Committee (RHSC). The TFDA has been serving as the co-champion of Good
Registration Management priority work area (PWA) with the Ministry of Health, Labour and
Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. By

promoting training and implementation of “good review practice” and “good submission practice”
under the collaboration of regulatory authorities and industry, this work advocates the concept of
“good registration management,” promotes mutual trust between regulatory authorities and the
pharmaceutical industry, and expedite regulatory convergence between APEC member economies
by 2020.

Implementation Measures

In cooperation with RHSC to implement the platform of the APEC Regulatory Science
Training Center of Excellence (CoE), each CoE hosting institution is responsible for developing

and hosting training programs following the core curriculum developed by the PWA champions.
The CoE serves as a platform to promote capacity, cooperation and regulatory convergence among
different APEC member economies.
The TFDA hosted an APEC Good Registration Management Regulatory Science Training
Center of Excellence Pilot Workshop in Taiwan in November 2016 and submitted an application
to RHSC together with RAPS Taiwan Chapter for recognition as a formal CoE in February 2017.
The application was endorsed without any objections in the RHSC Meeting on February 21, 2017.
TFDA, RAPS Taiwan Chapter, and APEC Life Science Innovation Forum have signed

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