Page 52 - 2019食藥署年報(英文版)

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The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation
Scheme (PIC/S) is an official international co-operative arrangement composed of regulatory
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the world. It is committed 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.
Expert Circles have been set up by PIC/S to facilitate the discussions and the exchange of
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1~2 years to develop draft guidance, recommendations, etc. and offer training in their respective
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has been active in developing models for QRM systems for Inspectorates as well as guidance
on the assessment of QRM implementation in industry. Expert Circle meetings and training
activities and held regularly to offer comprehensive training to inspectors to enable them to
inspect QRM systems in a harmonized manner.

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To enhance the bilateral collaboration relationship of medical products regulations between
Taiwan of Japan, provide a platform for communication and discussion between Taiwan and
Japan on pharmaceutical administration issues, regulatory science, medical products registration
and clinical trials, the Taiwan-Japan Relations Association and the Japan-Taiwan Exchange
Association have signed a "Framework of the Cooperation on the Medical Products Regulation
between Taiwan and Japan" on November 5, 2013. TFDA, Ministry of Health, Labour and
Welfare of Japan (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) have
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and regulations between Taiwan and Japan, and take turns to conduct conference every year.

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It has been 10 years since TFDA was invited to participate in the ICH conference in 1998.
In addition to attending the conference, participating in the working group with more than 20
experts to stipulate global drug technical guidance, TFDA will organize relevant training to

assist the domestic pharmaceutical industry to carry out the ICH related standards.
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