美国药品审评付费制度对我国加快药品审评的启示
Charging system in US PDUFA with reference to speeding up drug evaluation process of China
-
摘要: 目前我国药品审评时间长的问题已经引起业界广泛关注，药企付费以加快药品审评已成为制药行业的一致呼声。本文通过分析美国药品审评付费制度以及实施后产生的利与弊，结合我国药品审评现状，探讨如何运用收费方式加快我国药品审评。Abstract: The lengthy drug evaluation period has aroused wide attention. Fee payment by pharmaceutical enterprise has become common consensus of pharmaceutical industry. This paper analysies the advantages and disadvantages of drug evaluation charging system in the US with its reference to the current situation of drug evaluation in China, with an attempt to accelerate evaluation process by properly adopting the charging system in China.
-
Keywords:
- drug evaluation /
- fee payment /
- USA /
- China /
- comparative study /
- PDUFA
-
-
[1] MENET.Representative called for an increase in drug evaluation fee to ease the staff burden On drug evaluation[EB/OL].[2014-03-10].http://www.menet.com.cn/Articles/information/201403/201403100858595859_110449.shtml. [2] FDA.How many people are employed by FDA and in what areas do they work[EB/OL] ?[2014-03-23].http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Reports/BudgetReports/UCM301553.pdf. [3] Cantor DJ. Prescription drug user fee act of 1992: effects on bringing new drugs to market[EB/OL].[2014-04-29].http://digital.library.unt.edu/ark:/67531/metacrs416/m1/1/high_res_d/97-838e_1997Sep12.pdf. [4] Olson MK. The risk we bear: the effects of review speed and industry user fees on new drug safety[J].J Health Eco,2008,27(2):175-200. [5] FDA.PDUFA Performance Reports[EB/OL].[2014-03-23].http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/ucm2007449.htm. [6] Thaul S.Prescription Drug User Fee Act(PDUFA):2012 Reauthorization as PDUFA V[EB/OL].[2014-01-04].http://www.fas.org/sgp/crs/misc/R42366.pdf. [7] Establishment of prescription drug user fee rates for fiscal year 2002[EB/OL].[2014-01-04].http://www.gpo.gov/fdsys/pkg/FR-2002-01-16/pdf/02-1068.pdf. [8] FDA.Frequently asked questions on prescription drug user fees[EB/OL].[2014-01-04].http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm069943.htm#top. [9] FDA.FY 1995 PDUFA performance report[EB/OL].[2014-01-04].http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/ucm117257.htm. [10] Kronquist AR.The prescription drug user fee act:history and reauthorization issues for 2012[EB/OL].[2014-01-04].http://www.heritage.org/research/reports/2011/12/the-prescription-drug-user-fee-act-history-and-reauthorization-issues-for-2012. [11] Thaul S.The prescription drug user fee act(PDUFA):background and Issues for PDUFA IV reauthorization[EB/OL].[2014-4-29].http://www.amcp.org/WorkArea/DownloadAsset.aspx?id=11595. [12] GAO.Effect of user fees on drug approval times,withdrawals,and other agency activities[EB/OL].[2014-01-04].http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/PDUFA/ucm117257.htm. [13] LIU Peng.Commercialization of quasi-public service——The disputes on drug evaluation financing system in FDA[J].China Prescr Drug(中国处方药),2007(6):8-9.
计量
- 文章访问数: 1646
- HTML全文浏览量: 1
- PDF下载量: 2749
下载:
