Puzzles and revelations produced in process of U.S. local drug administration implement drug e-pedigree
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摘要: 目的 为我国正在实施的药品电子监管提供借鉴和参考。 方法 收集相关法规、报道和研究文献,分析美国FDA和州药品局在推行药品电子谱系过程中遇到的问题及原因。 结果 州药品局与FDA在技术方案、技术标准、预期效果、执行期限上存在分歧,医药企业则在应用效果、成本增加、信息共享、政策风险上对方案施行存有疑虑。 结论 修订技术标准,明确信息传递规则,暂缓行政追责,消除行业恐慌,是当前我国推行药品电子监管系统应予以重视和考虑解决的问题。Abstract: Objective To provide a reference for drug electronic supervision being implemented in China. Methods the problems and the reasons for US drug administration to implement of drug e-pedigree were analyzed by induction the bills, reports and literatures. Results There were differences between states board of pharmacy and FDA of technical solutions, technical standards, expected results, and implementation period. Pharmaceutical enterprises had doubts about program in the practical application, increasing costs, information sharing, and policy risks of drug e-pedigree. Conclusion Revising standards, definite of information transmission rules, suspension of holding accountable, and eliminating panic in the pharmacy industry, which should be valued and addressed as matter of priority in the process of implement drug electronic supervision by Chinese drug administration agencies.
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Key words:
- drug electronic supervise /
- FDA /
- drug e-pedigree /
- RFID
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[1] U.S. FDA. FDA 2006 Compliance Policy Guide for the Prescription Drug Marketing Act [EB/OL]. http://www.fda.gov/OHRMS/DOCKETS/98fr/06-9211.htm. 2006-11-15. [2] Board of Pharmacy, State of California. Background and Summary of the California ePedigree Law[EB/OL]. http://www.pharmacy.ca.gov/laws_regs/e_pedigree_laws_summary.pdf. [3] U.S. FDA. Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs[EB/OL]. http://www.fda.gov/oc/initiatives/counterfeit/rfid_cpg.html.2004-11-01. [4] U.S. FDA. Compliance Policy Guide[EB/OL]. http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074357.htm.2004-11-01. [5] Board of Pharmacy, State of California. California E——Pedigree Law[EB/OL]. http://www.pharmacy.ca.gov/about/e_pedigree_laws.shtml. [6] Claire Swedberg. GS1 Group Completes Early Phase of E-Pedigree Model[EB/OL]. http://www.rfidjournal.com/articles/view?7605. 2010-05-19. -
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