美国食品药品监督管理局的绩效考核方案及其对我国的启示
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摘要
美国从2010年开始采用一套特殊的绩效考核方案(FDA-TRACK)对FDA(食品药品监督管理局)进行考核,使FDA的整体运行有序,为公众食品药品安全提供了良好的保证.本文在介绍FDA-TRACK的同时,着重分析了该方案的优越性,并在此基础上提出对我国的借鉴意义.我国应设立专门的考核委员会考核国家食品药品监督管理总局(CFDA)绩效、建立官方网站公布考核信息、以结果为导向设计考核维度、构建职权清晰的监管法律体系、分析考核结果持续改进考核工作和构建内部系统促进资源共享,构建有中国特色的食品药品监督管理局绩效考核体系.
The U.S. since 2010 using a special set of performance appraisal scheme(FDA-TRACK) carries on the assessment to FDA(Food and Drug Administration), keeps FDA run in order, provides good guarantee for public food and drug safety. This paper analyzes the advantages of this scheme during introducing the FDA-TRACK, and puts forward a reference for China. The government should set up a special committee to examine the performance of China Food and Drug Administration(CFDA),establish the official website to publish the assessment information, design assessment dimension based on result oriented,establish a clear legal supervision system,analyze the results to improve the assessment work and build internal system to facilitate resource sharing. It is expected that our country will construct the performance appraisal system of CFDA with Chinese characteristics.
The U.S. since 2010 using a special set of performance appraisal scheme(FDA-TRACK) carries on the assessment to FDA(Food and Drug Administration), keeps FDA run in order, provides good guarantee for public food and drug safety. This paper analyzes the advantages of this scheme during introducing the FDA-TRACK, and puts forward a reference for China. The government should set up a special committee to examine the performance of China Food and Drug Administration(CFDA),establish the official website to publish the assessment information, design assessment dimension based on result oriented,establish a clear legal supervision system,analyze the results to improve the assessment work and build internal system to facilitate resource sharing. It is expected that our country will construct the performance appraisal system of CFDA with Chinese characteristics.
引文
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[3]FDA.About FDA-TRACK[EB/OL].2017,(2017-12-05)[2018-01-11].https://www.fda.gov/About FDA/Transparency/track/ucm195010.htm.
[4]FDA.FDA-TRACK Glossary[EB/OL].2017,(2017-12-05)[2018-01-11].https://www.fda.gov/About FDA/Transparency/track/ucm195700.htm.
[5]FDA.FDA-TRACK:Agency-wide program performance[EB/OL].2017,(2017-11-29)[2018-01-11].www.fda.gov/FDATrack.
[6]FDA.FDA-TRACK Program areas and dashboards[EB/OL].2018,(2018-01-24)[2018-01-30].https://www.fda.gov/About FDA/Transparency/track/ucm195008.htm.
[7]FDA.FDA-TRACK Newsletter archive[EB/OL].2017,(2017-12-05)[2018-01-11].https://www.fda.gov/About FDA/Transparency/track/ucm554713.htm.
[8]FDA.FDA-TRACK active[EB/OL].2017,(2017-12-05)[2018-01-11].https://www.accessdata.fda.gov/scripts/fdatrack/view/index.cfm.
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[10]陆倩妮,席晓宇,褚淑贞.英国药品和医疗保健产品管理局的绩效考核及其对中国药品审评的借鉴[J].中国新药杂志,2017,26(21):2497-2501.
[11]安抚东.推动统计管理创新服务食品药品监管[J].中国医药导刊,2017,19(01):102-104.
[12]国家食品药品监督管理总局.关于印发食品药品监督管理统计考核办法和2015年食品药品监督管理统计考核细则的通知[Z].2015-10-29.
[13]李佳颖,饶惠霞,彭仁贤,等.以透明度为视角浅谈我国药品监管[J].广东药学院学报,2015,31(06):799-802.
[14]王静,张欢,刘晓洁,等.关于我国食药监管体制及检验机构建设的建议[J].中国药事,2016,30(12):1228-1231.
[15]黄瀚博,杨世民.中美药监部门政务网站信息化建设比较研究[J].中国药事,2017,31(10):1113-1122.
[2]FDA.Performance management overview[EB/OL].2012,(2012-04-02)[2018-01-11].www.fda.gov/downloads/aboutfda/reportsmanualsforms/reports/budgetreports/ucm 298334.pdf.
[3]FDA.About FDA-TRACK[EB/OL].2017,(2017-12-05)[2018-01-11].https://www.fda.gov/About FDA/Transparency/track/ucm195010.htm.
[4]FDA.FDA-TRACK Glossary[EB/OL].2017,(2017-12-05)[2018-01-11].https://www.fda.gov/About FDA/Transparency/track/ucm195700.htm.
[5]FDA.FDA-TRACK:Agency-wide program performance[EB/OL].2017,(2017-11-29)[2018-01-11].www.fda.gov/FDATrack.
[6]FDA.FDA-TRACK Program areas and dashboards[EB/OL].2018,(2018-01-24)[2018-01-30].https://www.fda.gov/About FDA/Transparency/track/ucm195008.htm.
[7]FDA.FDA-TRACK Newsletter archive[EB/OL].2017,(2017-12-05)[2018-01-11].https://www.fda.gov/About FDA/Transparency/track/ucm554713.htm.
[8]FDA.FDA-TRACK active[EB/OL].2017,(2017-12-05)[2018-01-11].https://www.accessdata.fda.gov/scripts/fdatrack/view/index.cfm.
[9]LEE GWANHOO,KWAK Y H.An open government maturity model for social media-based public engagement[J].Govern Inform Quart,2012,29(4):492-503.
[10]陆倩妮,席晓宇,褚淑贞.英国药品和医疗保健产品管理局的绩效考核及其对中国药品审评的借鉴[J].中国新药杂志,2017,26(21):2497-2501.
[11]安抚东.推动统计管理创新服务食品药品监管[J].中国医药导刊,2017,19(01):102-104.
[12]国家食品药品监督管理总局.关于印发食品药品监督管理统计考核办法和2015年食品药品监督管理统计考核细则的通知[Z].2015-10-29.
[13]李佳颖,饶惠霞,彭仁贤,等.以透明度为视角浅谈我国药品监管[J].广东药学院学报,2015,31(06):799-802.
[14]王静,张欢,刘晓洁,等.关于我国食药监管体制及检验机构建设的建议[J].中国药事,2016,30(12):1228-1231.
[15]黄瀚博,杨世民.中美药监部门政务网站信息化建设比较研究[J].中国药事,2017,31(10):1113-1122.