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我国仿制药发展的SWOT分析
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篇名: 我国仿制药发展的SWOT分析
TITLE:
摘要: 目的:对我国仿制药发展的国内外环境进行分析,为仿制药的发展提出战略分析以供参考。方法:通过SWOT分析,对我国仿制药发展的自身优势、劣势及其所面临的外部机遇与挑战进行阐述,探索仿制药发展的思路和对策。结果与结论:我国仿制药发展的优势有销售价格低、研发成本低、可及性强、仿制药生产企业形成规模等;劣势有原料药质量参差不齐、制剂工艺不成熟、质量检验项目过于简单、参比制剂选用不统一导致生物等效性差等;机遇有原研药专利到期、人口老龄化、国内外市场空间巨大和政府支撑等;威胁有专利侵权带来的法律风险、市场竞争激烈、审评工作效率低和仿制药生产仅为低水平重复等。仿制药生产企业要利用优势、抓住发展机遇、回避威胁,充分意识到自身的劣势,扬长避短推动仿制药的发展。政府、仿制药生产企业应深刻剖析仿制药发展前景,通过政府的政策支撑、仿制药生产企业生产能力的提高,使我国仿制药得到充分发展。
ABSTRACT: OBJECTIVE: To analyze the domestic and overseas environment of Chinese generics development and put forward some references for development strategies of generics. METHODS: By SWOT analysis, the internal strengths and weaknesses, external opportunities and threats about Chinese generics development were interpreted to explore the thought and strategies. RESULTS & CONCLUSIONS: The development of Chinese generics shows the advantage of low sale price, low R&D cost, good accessibility, sizeable generics manufacturers; the disadvantage of various quality of raw material, immature preparation technology, too simple quality detection, poor bioequiavailability due to the disvnity of reference preparation. It faces the opportunities of original drug patent expiry, ageing of population, large domestic and foreign market and government support; and it also faces the threats of patent infringement risk, fierce market competition, poor efficiency of appraisal, low-level repeated production of generics. Generics manufacturers should seize the opportunity and avoid the threats by using advantages, be fully aware of own disadvantages and promote the development of generics by making best use of the advantages and bypassing the disadvantages.
期刊: 2016年第27卷第28期
编辑: 孟欣,宋跃晋
AUTHORS: MENG Xin,SONG Yuejin
关键字: 仿制药;SWOT分析;战略建议;政府;仿制药生产企业
KEYWORDS: Generics; SWOT analysis; Strategic suggestion;Government;Generics manufacturers
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