期刊文献+

药物警戒解析及与药品不良反应监测的区别 被引量:20

Analysis of Pharmocovigilance and Difference with the ADR Monitoring in China
下载PDF
导出
摘要 目的探讨药物警戒在中国的应用。方法对药物警戒的概念进行剖析,比较药物警戒与我国不良反应监测工作的区别。结果我国药品不良反应监测的对象、范围、方法均与药物警戒存在差距,但监测工作与国际药物警戒的理念一致,并朝着药物警戒的方向发展。结论实施药物警戒能为药品不良反应监测工作的发展提供更加广阔的空间。 Objective To explore the application of phannacovigilance in China. Mehods The concept of parmocovigilance and the differences between pharmacovigilance and ADR Monitoring were disserted. Results There is a gap between ADR monitoring and phaimacovigilance in the aspect of object, scope and method. However, ADR monitoring is in keeping with international pharmacovigilance theoretically and is developing towards it. Conclusion Phannacovigilancecan provide growth space for development of ADR monitoring in china.
出处 《中国药物警戒》 2017年第3期150-152,157,共4页 Chinese Journal of Pharmacovigilance
基金 国家食品药品监督管局总局委托课题(C201501)
关键词 药物警戒 药品不良反应监测 解析 区别 parmocovigilance, ADR monitoring analysis difference
  • 相关文献

参考文献1

二级参考文献20

  • 1European Commission. The EU pharmacovigilance system[EB/OL]. http://ec.europaeu/health/human-use/pharmacovigilance/index_en. htm#geninf( 2012-09-16 ).
  • 2Peter Arlett. New Pharmacovigilance legislation and focus on post-authorisation studies (2010-11-29)[EB/OL].www.diahome. org/.../24003/session%203_peter%20arlett.pdf (2012-9-16).
  • 3European Medicines Agency. 2010 pharmacovigilance legislation [EB/OL].http://www.ema.europa.eu/ema/index.j sp curl=pages/ regulation/general/general_content_000492.j sp&mid=WC0b01 ac 058033e8ad (2012-9-16).
  • 4European Medicines Agency. Commission Implementing Regula- tion (EU) No 520/2012 (2012-6-19)[EB/OL]. http://eurx.europa. eu/LexUriServ/LexUriServ.do?uri=OJ:L:2012:159:0005:0025: EN:PDF (2012-9-16).
  • 5European Medicines Agency. Good Pharmacovigilance Practices [ EB/OL ]. http://www, ema. europa, eu/ema/index .j sp curl=pages/ regulation/document_listing/document_listing_000345. j sp&mid=WC0b01 ac058058f32c ( 2012-9-16 ).
  • 6European Medicines Agency. GVP Module I Pharmacovigilance Systems and their Quality Systems (2012-6-22) [EB/OL].http:// www.ema.europa.eu/docs/en_GB/document_library/Scientif- ic_guideline/2012/06/WC500129132.pdf( 2012-09-17 ).
  • 7European Medicines Agency. GVP Module II Pharmacovigilance System Master File(2012-6-22 ) [EB/OL].http://www.ema.europa. eu/docs/en GB/document_library/Scientific_guideline/2012/06/ WCS00129133.pdf(2012-09-17).
  • 8European Medicines Agency. GVP Module III Pharmacovigilance Inspections( 2012-6-22 ) [EB/OL] .http://www.ema.europa.eu/docs/en_ GB/document_library/Scientific_guideline/2012/06/WC500129243. pdf(2012-09-17).
  • 9European Medicines Agency. GVP Module V- Risk Management Systems( 2012-6-22 )[EB/OL].http://www.ema.europa.eu/docs/en_ GB/document_library/Scientific_guideline/2012/06/WC500129134. pdf(2012-9-18).
  • 10European Medicines Agency. GVP Module VI - Management and Reporting of Adverse Reactions to Medicinal Products( 2012-06- 22) [EB/OL].http://www.ema.europa.eu/docs/en_GB/document_ library/Scientific_guideline/2012/06/WC500129135.pdf( 2012- 09-18).

共引文献22

同被引文献205

引证文献20

二级引证文献72

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部