Pharmaceutical product standards and international trade in Taiwan: A Case study on PIC/S GMP

• Main Authors: Lin, Sheng Yu, 林聖峪
• Other Authors: Tsai, Meng Jia
• Format: Others
• Language: zh-TW
• Published: 2008
• Online Access: http://ndltd.ncl.edu.tw/handle/08428115679103398218

碩士 === 國立政治大學 === 國際經營與貿易研究所 === 96 === Product standards play an important role in modern societies. However, they also raise many concerns about technical barriers to trade, particularly for pharmaceutical products which must comply with numerous stringent product standards, such as GMP standards. Therefore, PIC/S aims at reducing the technical barriers to pharmaceutical trade by providing a common GMP standard, which the Bureau of Food and Drug Analysis of Taiwan declared to introduce PIC/S GMP in 2007, and to fully enforce in 2013. This study will examine how PIC/S decreases technical barriers to trade for pharmaceutical products with principals in the WTO TBT Agreement. In addition, since Taiwan pharmaceutical industry has low competitiveness for a long time, how PIC/S GMP will affect the pharmaceutical industry and international trade of Taiwan is another main issue of this study.