• 中国精品科技期刊
  • 中国高校百佳科技期刊
  • 中国中文核心期刊
  • 中国科学引文数据库核心期刊
Advanced Search
SHAO Rong, YIN Tianhong. Charging system in US PDUFA with reference to speeding up drug evaluation process of China[J]. Journal of China Pharmaceutical University, 2014, 45(3): 281-285. DOI: 10.11665/j.issn.1000-5048.20140305
Citation: SHAO Rong, YIN Tianhong. Charging system in US PDUFA with reference to speeding up drug evaluation process of China[J]. Journal of China Pharmaceutical University, 2014, 45(3): 281-285. DOI: 10.11665/j.issn.1000-5048.20140305
shu

Charging system in US PDUFA with reference to speeding up drug evaluation process of China

More Information
    Graphical Abstract
    • 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.
    • FullText(HTML)
    • References (13)
  • [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.
    • Related Articles

  • Related Articles

    [1]LI Xue, AI Yongling, HE Qunye, YANG Gongjun, WANG Jing. Detection of prostate specific antigen-based on dual signal amplified electrochemical immunoassay[J]. Journal of China Pharmaceutical University, 2018, 49(4): 433-440. DOI: 10.11665/j.issn.1000-5048.20180408
    [2]SONG Fengjuan, AI Yongling, ZHONG Wenying, WANG Jing. Detection of copper ions and glutathione based on off-on fluorescent graphene quantum dots[J]. Journal of China Pharmaceutical University, 2018, 49(1): 87-92. DOI: 10.11665/j.issn.1000-5048.20180112
    [3]ZHOU Weisai, WU Zimei, BAGULEY Bruce C., LI Caibin, ZHANG Wenli, LIU Jianping. Preparation of CI-921 mixed micelles and determination of its entrapment efficiency by method of dialysis and fitting[J]. Journal of China Pharmaceutical University, 2016, 47(5): 575-580. DOI: 10.11665/j.issn.1000-5048.20160512
    [4]WU Mingming, FANG Lei, GOU Shaohua, CHEN Li. 以2-甲基-2-取代苯氧基丙酸为离去基团的铂(Ⅱ)配合物的合成、表征及细胞毒活性[J]. Journal of China Pharmaceutical University, 2013, 44(4): 303-306. DOI: 10.11665/j.issn.1000-5048.20130403
    [5]Synthesis of violet-near-infrared-emitting quantum dots using N-acetyl-L-cysteine as ligand[J]. Journal of China Pharmaceutical University, 2010, 41(5): 456-461.
    [6]BESN System of Multi-channel Tail-artery Blood Pressure Measurement[J]. Journal of China Pharmaceutical University, 2004, (5): 80-83.
    [7]Preparation and Antibacterial Testing of dihydroxyaluminum sodium carbonate and its Tablet[J]. Journal of China Pharmaceutical University, 1998, (3): 84-86.
    [8]DISCUSSION OF STABILITY OF THE YIN-YANG EQUATION[J]. Journal of China Pharmaceutical University, 1987, (1): 40-44.
    [9]UV SPECTROPHOTOMETRIC ANALYSIS OF MULTICOMPONENT COMPLEX PREPARATION BY THE LEAST SQUARES AREA FITTING METHOD[J]. Journal of China Pharmaceutical University, 1986, (3): 201-207.
    [10]Dong Shanshi, Yang Jingrong, An Dengkui. DETERMINATION OF NONOXYNOL-9 IN THE CAPSHAPED CONTRACEPTIVE FILMS BY ORTHOGONAL POLYNOMIAL SPECTROPHOTOMETRY[J]. Journal of China Pharmaceutical University, 1982, (3): 57-58.

Catalog

    Get Citation
    PDF
    XML
    Article views (1640) PDF downloads (2749) Cited by()
    Turn off MathJax
    Article Contents
    Abstract
    References
    Related Articles

    Copyright © Journal of China Pharmaceutical University苏ICP备12050101号-2

    Address：24 Tongjia Lane, Nanjing City, Jiangsu Province （210009）Tel: 025-83271566E-mail: xuebao@cpu.edu.cn

    Supported by: Beijing Renhe Information Technology Co., Ltd.  Baidu Analytics

    Total visits：292734

    /

    DownLoad:  Full-Size Img  PowerPoint
    Return
    Return