国外药品监管透明度研究综述

Review of Foreign Drug Regulatory Transparency

目的:了解国外药品监管透明度的研究现状,为进一步的研究指明方向。方法:采用文献荟萃法对国外关于药品监管透明度的相关资料进行荟萃分析。结果:WHO、药品透明联盟、透明国际、美国等对药品监管透明度研究较多。WHO启动了药品良好治理项目,并开发了测量药品透明度的药品良好治理项目的评估工具;药品透明联盟关注于国家的药品政策、药品采购和供应链管理中的透明度的提高;透明国际组织侧重在药品腐败控制与透明度策略研究;美国FDA采取了一系列的措施提高医药行业的透明度。结论:药品监管透明度的研究有一定发展,但仍然很不完善:关于药品监管透明度具体测量方法的研究相对薄弱;提高药品监管透明度具体措施的研究不足;药品监管透明度的研究多为定性的探讨,缺乏定量分析和数据支撑。

Objectives：To have a comprehensive understanding of research status on the drug regulatory transparency.Methods：Searching the literatures related to drug regulatory transparency,then summarizing and analyzing them.Results：WHO,Medicines transparency alliance,transparency international,the U.S.and some scholars more studied the transparency of the drug regulatory.WHO launched the good governance for medicines and developed its measurement tools.Medicines transparency alliance studied the increase of transparency in national drug policy,drug procurement and supply chain management.Transparency international focused on the drug corruption control and transparency strategy research.FDA adopted a series of measures to improve the transparency of the pharmaceutical industry.Conclusion：The theory research had great development,but it is still not perfect：the research about specific measurement methods of transparency is relatively weak;the research about the concrete measures of improve the transparency is insufficient;The research of the drug regulatory transparency lacked of quantitative analysis and data support.