“十二五”时期,我国医药制造业将继续保持强劲发展势头,药品监管工作面临着巨大的挑战和机遇。立足我国目前药品监管资源,提升药品安全监管能力、药品质量水平,保障广大人民生命与健康,实现对我国药品安全形势科学监管意义重大。基于国内外药品安全监管实施经验总结和对药品安全相关政策法律的分析,本文构建了药品安全监管评价指标体系,并基于遴选原则确立了药品安全监管的核心指标。
<<Chinese pharmaceutical industry will continue to maintain high growth,and national drug administration is facing enormous challenges and opportunities during Twelfth Five-Year. It will be scientific significant for Chinese drug administration to hold the present resources,promote controlling level of drug safety,improve drug quality status,ensure the people’s health. Basing on the drug safety being control experience of domestic and foreign government,and analysis of the regulation and policy related to the drug safety,the paper built an administration Indicator system of drug safety and selected the core indicators according to several screening principles.
<<