Page 53 - 2019食藥署年報(英文版)

In June 2018, in the ICH conference held in Kobe City, TFDA became the 10th regulatory
ICH member after the membership of European Union of Europe, Food and Drug Administration
of the United States, Health Canada of Canada, Ministry of Health, Labour and Welfare of Japan
(MHLW), Swissmedic of Switzerland, Health Sciences Authority (HSA) of Singapore, Ministry
of Food and Drug Safety of South Korea, National Medical Products Administration (NMPA)
of China, Brazilian Health Regulatory Agency(Anvisa) of Brazil. It is an important milestone
for TFDA to join an international organization for pharmaceutical cooperation, and it is also a
recognition of the drug regulations in Taiwan that meet the international regulatory standards.

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Cooperating with the RHSC to comprehensively promote the platform of APEC Regulatory
Science Training Center of Excellence (CoE), the CoEs conduct personnel training based on the
core curriculum set by each of the priority work area, to promote the capability, cooperation and
regulatory convergence among the APEC member economies.
TFDA hosted the "2018 APEC Good Registration Management (GRM) Regulatory
Science Center of Excellence Workshop." This training event was co-organized by the PMDA
of Japan, the Asia Partnership Conference of Pharmaceutical Associations (APAC) and RAPS

Taiwan Chapter.
The courses included common sessions and concurrent reviewer-specific sessions and
applicant-specific sessions. A total of 62 trainees from 14 APEC member economies joined
the training. The trainees were from Hong Kong, Indonesia, South Korea, Chile, Japan,
Malaysia, Papua New Guinea, Philippines, Singapore, Thailand, Vietnam, Mexico, Peru, and
Taiwan. Upon the completion of the training course, the participants shall be able to assist their
institutions, associations or companies to deliver personnel training, to promote the concept of
Good Registration Management (GRM) in individual APEC member economies.

This workshop invited 28 domestic and overseas regulatory experts to deliver training.
They shared the principles of Good Registration Management (GRM) with their practical
experiences.

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The PIC/S Expert Circle on Quality Risk Management (QRM) & Training Event includes
a 2-day training course and a 1-day Expert Circle meeting. Internationally renowned experts,
senior GMP inspectors, and experienced speakers from the industry have been invited from

countries including the U.S., the U.K., Austria, Ireland, Iran, and Taiwan, and the participants
are key talents nurtured by GMP inspectorates worldwide. The curriculum is designed under
the QRM framework, and consists of keynote speeches and multi-theme workshops, involve the
topics of principles, tools and examples related to the implementation of QRM in industry, risk
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