FDA风险评估与减低策略实施与借鉴的思考

中国药物警戒 ›› 2017, Vol. 14 ›› Issue (5): 283-288.

FDA风险评估与减低策略实施与借鉴的思考

鲍程程, 王宏伟, 杨悦*

沈阳药科大学工商管理学院,辽宁沈阳 110016

收稿日期:2017-07-12 修回日期:2017-07-12 出版日期:2017-05-20 发布日期:2017-07-12
通讯作者: 杨悦,女,教授·博导,药事管理与法规,临床药学。E-mail：yyue315@vip.126.com

Consideration on Implementation and Reference Through FDA Risk Evaluation and Mitigation Strategy

BAO Cheng-cheng¹, WANG Hong-wei², YANG Yue^*

School of Business Administration, Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2017-07-12 Revised:2017-07-12 Online:2017-05-20 Published:2017-07-12

摘要/Abstract

摘要： 目的对美国药品风险评估和减低策略（REMS）制度的发展历程、内容及实施过程等进行系统分析和介绍,以期推进我国药品风险控制计划。方法通过查阅中外文献和美国FDA官网有关REMS政策与进展。结果药品上市申请人通过制定 REMS来确保药品效益大于风险,同时美国制定一系列法律法规和指南促进REMS的有效实施。结论美国REMS制度可为我国药品风险控制计划提供参考。

关键词: 风险评估和减低策略, FDA, 风险控制计划

Abstract: Objective This article makes an introduction of the FDA's Risk Evaluation and Mitigation Strategy and development process to provide suggestions to conduct Risk Evaluation and Mitigation Strategies (REMS) in China. Methods Studying material of REMS in US Food and Drug Administration (FDA) official website and analyzing related literature. Results application ensures that the benefits of a drug outweigh the risks of the drug by developing REMS,and U.S publishes a series of regulation and guidance to ensure REMS implement .Conclusion REMS could give some references for risk control measures.

Key words: Risk Evaluation and Mitigation Strategy, FDA, Risk Control Plan

中图分类号:

R951

鲍程程, 王宏伟, 杨悦*. FDA风险评估与减低策略实施与借鉴的思考[J]. 中国药物警戒, 2017, 14(5): 283-288.

BAO Cheng-cheng, WANG Hong-wei, YANG Yue. Consideration on Implementation and Reference Through FDA Risk Evaluation and Mitigation Strategy[J]. Chinese Journal of Pharmacovigilance, 2017, 14(5): 283-288.

参考文献

[1] 宁艳阳,杨悦.美国药品风险管理对我国的启示[J].中国新药杂志, 2010,19(23):2120-2123.
[2] 李延敏,戴秋萍,杨悦.美国药品风险减低措施及其对中国的启示[J].中国新药杂志, 2010,19(21):1928-1931.
[3] FDA. Guidance for Industry Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications[EB/OL].(2009-09)[2016-10-08].www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm184128.pdf.
[4] 赵频,边蕾,杨悦.FDA风险评估与减低策略及其对我国的启示[J].中国药物警戒, 2013,10(03):140-144.
[5] FDA. Standardizing and Evaluating Risk Evaluation and Mitigation Strategies(REMS)[EB/OL].(2014-09)[2016-10-09].http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM415751.pdf.
[6] FDA. Introduction to REMS@FDA[EB/OL].(2015-06-23)[2016-10-09].http://101.96.10.46/www.fda.gov/downloads/AboutFDA/ WorkingatFDA/ FellowshipInternship Gradu ateFaculty Programs /Pharmacy Student Experiential Program CDER/UCM452237.pdf.
[7] FDA. Office of Surveillance and Epidemiology(OSE)-Divisions[EB/OL].(2016-02-12)[2016-09-19].http://www.fda.gov/ AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/ CDER/ucm169536.htm.
[8] FDA. CDER 21st Century Review Proces Desk Reference Guide[EB/OL].(2014-09)[2016-09-19].http://www.fda.gov/down loads/aboutfda/centersoffices/officeofmedicalproductsand tobacco/cder/ manualofpoliciesprocedures/ ucm218757.pdf.
[9] FDA. FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary[EB/OL].(2016-09)[2016-10-08].http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm521504.pdf.
[10] FDA. Risk Evaluation and Mitigation Strategies: Modifications and Revisions Guidance for Industry[EB/OL].(2015-04)[2016-10-10].http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm441226.pdf.
[11] FDA. MAPP 4151.3 Rev.4[EB/OL].(2016-09-14)[2016-10-08].http://www.fda.gov/downloads/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/manualofpoliciesprocedures/ucm073564.pdf.
[12] 李淑芳,潘文灏.美国药品风险评估与减低计划的简介与启示[J].中国药物警戒, 2013,10(5):283-285,290.
[13] 谭燕,王琳.美国药品风险评估和减低计划[J].中国新药与临床杂志, 2014,33(06):425-429.
[14] 许荣芹,许美婷,杨悦.刍议美国罗格列酮的风险评估与减低计划[J].中国药物警戒, 2013,10(12):714-718.
[15] FDA. Recommendations for regulatory actions-rosiglitazone[EB/OL].(2010-09-02)[2016-10-10].http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInfor mationforPatientsandProviders/UCM226236.pdf.
[16] FDA. NEWS RELEASE[EB/OL].(2015-12-16)[2016-10-10].http://www.fda.gov/Drugs/DrugSafety/ucm376389.htm.