Page 55 - 2018食藥署年報(英文版)

Indonesia, South Korea, Malaysia, Papua New Guinea, the Philippines, Singapore, Thailand,
Vietnam and Taiwan. The trainees should take part in organizing training sessions at their
respective institutions, associations or companies to promote the concept of Good Registration
Management to more APEC member economies. In addition, experts from Canada, Japan, the
Philippines, Singapore, and UK were invited as speakers at the meeting to share their opinions
and practical experience about Good Registration Management principles.
The event was well-recognized and obtained positive feedbacks from participants of
different APEC member economies. After the event, the TFDA received requests from several
APEC member economies for providing training materials and lecturers to help their organization

of local training sessions. Serving as a hosting institution of the APEC Good Registration
Management Regulatory Science Training Center of Excellence (CoE) not only increases the
international visibility of TFDA but also facilitates our opportunities in international collaboration.

Section 7 Participation in PIC/S

Origin of Policy

The Pharmaceutical Inspection Co-operation Scheme (“PIC/S”) refers to the official

international organization composed of regulatory authorities in the field of Good Manufacturing
Practice (GMP) of medicinal products from all over the world. The organization devoted to the
international development, implementation and maintenance of harmonized GMP standards and
quality systems of inspectorates and facilitating the co-operation and networking of competent
authorities. Every year, the PIC/S Committee Meeting and annual seminar will be hosted by
different PIC/S Participating Authority, as the largest PIC/S event, the seminar will focus on a
particular aspect of GMP topic and open to inspectors from PIC/S Participating Authorities and
other interested Medicine Regulatory Authorities.

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