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发达国家药品安全规制经验及对中国的启示 被引量:4

On Drug Safety Regulations in Developed Countries and its Revelations to China
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摘要 发达国家药品安全规制机构独立,法律体系及召回制度完善,对中国建立健全药品安全规制体系具有重要启示作用。我国需要建立健全独立高效的药品安全规制机构,完善药品安全规制法律体系,发挥药品专家咨询委员会的作用,健全药品召回制度,提高技术支撑能力。 Drug safety is related to the health of people's livelihood projects, regulating drug safety is the governments' responsibility. The developed countries have made great achievements in the field of drug safety regulation. Summing up some successful experience of the developed countries' drug safety regulation, combining with China's reality, and learning from these experiences, which has great enlightenment on improving China' s drug safety regulation and developing people's livelihood.
作者 王淑娟
出处 《开放导报》 CSSCI 北大核心 2011年第5期66-69,共4页 China Opening Journal
关键词 药品安全 规制体制 召回制度 Drug Safety Regulation System Recall
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参考文献5

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  • 2European Medicines Agency Committee for Medicinal Products for Human Use. Guideline on risk management systems for medicinal products for human use[EB/OL], http://www.emea/chmp/96268/2005, 2010-03-20.
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