國際醫藥品稽查協約組織優良製造規範政策對國內西藥製劑廠策略選擇之研究

The impact of PIC/S GMP standards on strategic choices for Taiwanese pharmaceutical firms

劉宗玲(Chung-Ling Liu)

指導教授 ： 李培齊

淡江大學/商管學院/管理科學學系企業經營碩士在職專班/碩士(2016年)

https://doi.org/10.6846/TKU.2016.01035

摘要

本研究主要探討國內西藥製劑廠不僅多年來面臨健保藥價政策外，隨著PIC/S GMP政策推動落實執行後，在策略選擇上的趨勢及競爭力的變化，並提供政策建言，期助於加速政策與產業發展連動成效。
研究發現，西藥製劑廠正處藍海及紅海版塊劇烈變動關鍵期，法規對產業發展策略影響甚大，聚焦於主力產品或技術平台，形成各廠對於企業長期策略發展的關鍵決策，讓產業多朝利基市場或特殊製劑廠方向發展，而委託代工藥品將因成本高，喪失市場優勢時，終退出市場或與委託藥廠達成競合關係共享市場。
藉此研究提出對政府主管機關及西藥製劑廠的建議，希望讓國內西藥製劑廠得以朝向良性及穩健的產業體質發展，並照護國人用藥權益及健康。

關鍵字

西藥製劑廠 ； 優良製造規範 ； 競合關係 ； 利基市場 ； 特殊製劑廠

並列摘要

This study focuses on the evolvement of coping strategies and competitiveness of Taiwanese pharmaceutical firms having faced with challenges of national health insurance policy on medicine prices over the years as well as pressures to upgrade facilities along with the enforcement of PIC / S GMP standards. There are a few policy suggestions proposed in this study, with the hope to help foster the coordination between policy makers and the pharmaceutical industry for the good of the society.

Research shows that Taiwanese pharmaceutical firms are facing drastic changes in the crossroad of Blue Sea and Red Sea. Regulations are relevant in this critical period for they have great impact on the industrial development strategy. Focusing on major products or technology platforms will be key decisions for the long-term strategic development of pharmaceutical firms, and this would lead the industry to concentrate on developing niche markets or specific dosage producing plants. Cost of contractual manufacturing would inevitably rise and make the commissioning firms lose their competitiveness. Eventually some pharmaceutical firms have no choice but exiting the market or building co-opetition relationships with contract manufacturers.

This study proposes a few suggestions to government authorities as well as Taiwanese pharmaceutical firms, with the hope to foster a healthier and solider industrial structure for domestic pharmaceutical industry, whereby secure the rights and health of the public.

並列關鍵字

Taiwanese Pharmaceutical Firms ； PIC/S GMP ； Co-opetition Relationship ； Niche Markets ； Specific Dosage form Plants

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