Page 56 - 2019食藥署年報(英文版)

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Through Joint Conference of Taiwan and Japan on Medical Products Regulation (Figure
3-6), promoted the exchange and understanding of laws and regulations on both sides, and
strengthened cooperation and mutual trust between officials and operators on both sides.
Looking forward to reaching a consensus on joint review under the cooperation framework of
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medical device industries of both countries.

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The sales of medicinal products are strictly regulated in countries around the world.
The management regulations and criteria in different countries are different. Therefore, the

regulatory harmonization is significantly important to the development of the market for
medicinal products. To promote regulatory harmonization for medicinal products, the European
Union, the United States and Japan founded the International Council for Harmonization of
Technical Requirements for Pharmaceuticals for Human Use (ICH) in 1990. The organization
actively discussed topics on various technical specifications, promoting training and global
cooperation. Besides, ASEAN countries have also established Pharmaceutical Product Working
Group (PPWG) to promote the regulatory harmonization for medicinal products in ASEAN

54 countries.