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国外儿童药物审评审批管理现状及特点分析 被引量:12

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摘要 目的介绍主要发达国家和地区儿童药物管理法规的发展历程及现状,并对其管理特点做了综合分析,希望能为我国制订相关法规提供参考和借鉴。方法通过调研国外药品注册管理相关法规和指导原则,分析了美国、欧盟、日本及韩国有关儿童药物审评审批的一些特殊政策和法规,同时也对我国儿童药物的目前审评审批状况做了简要介绍。结果与结论一些发达国家均针对儿童药物开发的特殊性,就其研发及注册审评审批进行了不同程度的政策倾斜,以鼓励儿童药物的开发和研究。
出处 《中国药学杂志》 CAS CSCD 北大核心 2012年第10期745-748,共4页 Chinese Pharmaceutical Journal
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  • 1DANIEL K B,BRIAN S,JESSICA M S,et al. Pediatric drug tri- als : safety and transparency [ J/OL]. Arch Pediatr Adolesc Med, 2009, 163 ( 12 ) : 1080-1086 [ 2011-03-24 ]. http://archpe- di. ama-assn, org/cgi/reprint/163/12/1080.
  • 2Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: The Content and For- mat for Pediatric Use Supplements [ EB/OL ] . http:// www. fda. gov/downloads/Drugs/GuidanceComplianceRegulatory- Informatiorr/Guidances/ucm071957.
  • 3Food and Drug Administration. In Proceedings of 105th Congress of the United States of America[ EB/OL]. http://www, fd& gov! downloads/RegulatoryInformation/Legislation/FederalFoodDru- gandCosmetieActFDCAct/SignificantAmendmentstotheFDCAct/ FDAMA/FullTextofFDAMAIaw/UCM089145.
  • 4Food and Drug Administration. Regulations Requiring Manufac- turers to Assess the Safety and Effectiveness of New Drugs and Bi- ological Products in Pediatric Patients; Final Rule[ EB/OL]. ht- tp://www, fda. gov/ohrms/dockets/98fr/120298c.
  • 5MARTIN W. The New Paediatric Regulation in the EU-Development, Implications and Comparison with US Experiences in Pae- diatric Drug Development [ EB/OL ] . Bonn Univ. of Bonn, 2007. http://www, dgrz. de/studiengang/pdf/master_watzl_m.
  • 6Food and Drug Administration. In Proceedings of 107th Congress of the United States of America[ EB/OL]. http://www, fda. gov/ downloads/Drugs/DevelopmentApprovalProcess/DevelopmentRe- sources/UC M049874.
  • 7SMITH P B, DANIEL K B, DANIEL M, et al. Safety Monitoring of Drugs Receiving Pediatric Marketing Exclusivity[ J/OL]. Pedi- atrics. , 2008, 122 ( 3 ) : e628-33 [ 2011-03-08 ] . http:// www. nebi. nlm. nih. gov/pmc/articles/PMC2561901/pdf/ni- hms53685.
  • 8Food and Drug Administration. Safety Reporting[ EB/OL]. ht- tp ://www. fda. gov/ScienceResearch/SpecialTopics/Pediatric- TherapeuticsResearch/ucm123229.
  • 9Food and Drug Administration. In Proceedings of 108th Congress of the United States of America [ EB/OL]. http ://www. fda~ gov/ downloads/Drugs/DevelopmentApprovalProcess/DevelopmentRe- sources/UCM077853.
  • 10Food and Drug Administration. In Proceedings of 110th Congress of the United States of America [ EB/OL ] . http:// www. fda. gov/downloads/Drugs/DevelopmentApprovalProcess/ DevelopmentResources/UCM049870.

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