產品標準在現今社會中扮演非常重要的角色，但也容易造成許多技術性貿易障礙。醫藥產品由於攸關人類身體的健康及安全，因此相較於其他行業，各國對藥品皆設有許多嚴格的產品標準及技術法規，對藥品的國際貿易產生嚴重的技術性貿易障礙。PIC/S制定共通的GMP標準，並且旨在降低醫藥產品在國際貿易及流通上所面臨的非關稅貿易障礙。台灣藥物食品檢驗局於2007年公告實施PIC/S GMP，預計於2013年開始全面實施。本研究關注的核心議題，主要將以WTO對技術性貿易障礙的主要規範原則，分析探討PIC/S降低醫藥產品技術性貿易障礙的功能。另外，台灣製藥業由於缺乏關鍵技術、藥廠家數眾多、生產規模小，惡性競爭十分激烈，未來實施PIC/S GMP後，對我國製藥業的衝擊不容小覷，因此本研究另一項主要議題是PIC/S GMP對我國製藥業及藥品貿易之可能影響。 / 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.
| Identifer | oai:union.ndltd.org:CHENGCHI/G0094351040 |
| Creators | 林聖峪, Lin, Sheng Yu |
| Publisher | 國立政治大學 |
| Source Sets | National Chengchi University Libraries |
| Language | 中文 |
| Detected Language | English |
| Type | text |
| Rights | Copyright © nccu library on behalf of the copyright holders |
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