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药品数据保护在我国的发展探讨 被引量:9

Discussion on Development of Drug Data Protection in China
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摘要 目的:探讨药品数据保护在我国的发展。方法:比较美国和欧盟药品数据保护的具体措施,分析我国药品数据保护的不足, 并提出建议。结果与结论:我国目前尚处于药品数据保护的初级阶段,政府和药品监督管理部门应借鉴欧、美等国的经验,制订明确 的药品数据保护的实施细则。 OBJECTIVE: To discuss the development of drug data protection in China. METHODS: The specific data protection measures taken by United States (US) and the European Union (EU) were compared and the drawbacks of China drug data protection were analyzed; then some suggestions were put forward. RESULTS & CONCLUSION: The drug data protection in China is still only in its infancy. The Chinese government and drug administration should work out definite drug data protection bylaws by drawing experiences from US and EU.
出处 《中国药房》 CAS CSCD 北大核心 2005年第21期1606-1608,共3页 China Pharmacy
关键词 药品 数据保护 注册 药品研发 Drugs Data protection Registration Drug Research and Development
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  • 2Eisenberg, Rebecca S., 2001, "The Shifting Functional Balance of Patents and Drug Regulation," Health Affairs, September/October.
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  • 10(Kaiser) The Kaiser Family Foundation, 2001, Prescription Drug Trends : A Chartbook Update, November.

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