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

Abstract

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

CLC Number:

R951

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.

References

[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.