大韩民国药物警戒系统概述：从最佳实践中学习

概述大韩民国药物警戒系统授权公开披露 WangHuihuiWangPaäricioV.MarquezAlberguerasKseniyaBieliaieva ©2022年意大利国家银行/Woíld银行 1818年华盛顿特区西北圣城20433电话：202-473-1000Inte²net：www.wo²ldbank.og² 这个woík是Woíld银行的工作人员的外部管理。在这个woík中阐述的调查结果，信息和结论不一定要反映Woíld银行的观点，它的行政机构的信息，以及他们的政府。 Woíld银行不保证本woík中包含的数据的准确性，完整性，准确性，准确性，也不假定信息中的任何eíoíoíoíoíoíoíoípossibility，oíliabilitywithíespecttotheuseofoíuíetousetheinfoímation,methods,本地图中任何地图上显示的边界、颜色、面额和其他信息并不意味着对Woíld银行的法律地位的任何判断，即承认任何此类边界的法律地位。 任何海因都不构成对沃德银行的证券和豁免的限制，所有这些都是明确的。 此woík中的材料受版权约束。由于Woíld银行对其知识进行传播，因此只要给予此woík充分的支持，该woík就可以在整个oít中被引入。 任何许可证和许可证，包括补贴，都应添加到WoíldBankPublications，TheWoíldBankGíoup，1818HStíetNW，华盛顿特区20433，美国；传真：202-522-2625；电子邮件：pubíights@woíldbank.oíg。 概述大韩民国药物警戒系统 Con到处都是 Pha í macosopulation中的报告和基本公共卫生服务Sey í ies iv致谢v同义词vi1.国际生产12.Ko í ea的Dug法规..................................................................................................2立法2Regulatoy机构.....................................................................................................................................................................3资金支持药物............................................................................................................................................................33.在科伊亚监测Safiety of i D í ugs和药品...................................................................4国家法哈麦克警戒的总体观点系统................................................................................................................4TheøoleoftheMFDS.............................................................................................................................................4Phaàmacovanumovanuitary系统...................................................................................................................5KoeaDug安全与风险研究所管理....................................................................................................................6PhaämacovanuitorizationNetwo♪k在Ko♪ea.............................................................6TheKo街区eaAdvesses现场事件报告系统..............................................................................................9建立积分的'Compin^ehensiveDug信息系统（NeDug）'............................................................................................................................................................10由医院/诊所，Phamacies，Consumeós和PhaimemaceuticalCompanies撰写的广告事件报告的完整性Koea.......................................................................................................................................11ChaqactestisticsandTendsoftheeeuticineffectivenessoftheeeuticineuticityinKoea...12Phamacacepidemiphology13Dug利用率审查(DUR)Koea.............................................................................................................................14Dug利用率审查的影响.................................................................................................154.基于PhaímaceuticalSafietyInfioímation的SafietyMeasureRepoíts....................................16基于国产制药安全的安全措施信息信息Repoàts.................................................................................................................................................16基于Pha飞船信息的安全度量安全系数Aboad.......................................................................................................................................................16建立安全使用疫苗的基地，使整个生命周期和世界卫生组织的Püe资格（PQ）.....................................................................................16 5.ADVíseDíug反应（ADR）救济系统....................................................................................................17《产品责任法》17采购责任索赔18 6.Ko í ea的Pha í macoanciation中的挑战和未来影响系统19 7.收获：科伊亚的经验教训Safiety ofi Medicines 20 8. Tables 表1.Phaímaco警戒发展的里程碑系统在Ko í ea...............................................................................................5表2. Fo í KIDS资金，2016 - 2021年.........................................................................6 数字 Figuíe..............................................................................................................................4Figu í e 2. Regional Pha í macovanuanciation Cente í in Ko í ea......................................7Figu í e 3. Opeating System of RPVCs............................................................................8Figu í e 4. Repo í ts f í om RPVCs, pe í yea í....................................................................9Figu í e 5. Koiea 's Adve í se D í ug Repo í ting System..................................................10Figu í e 6. Repoted í ted individual Case Safety Repo í ts (ICSRs), by yea í......................11Figu í e 7. Pha í macoepidemiology Activities in Ko í ea...............................................13图8. DUR作为COVID - 19反应的Pait.......................................................................14Figu í e 9. Adve í se D í ug Reaction Relief System Flow Cha í t.....................................18Figu í e 10. Types of Relief Benefits......................................................................