患者参与药物监管的国际经验与启示

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中图分类号R95 文献标志码A 文章编号 1001-0408（2025）08-0908-06

DOI 10.6039/j.issn.1001-0408.2025.08.03

International experience and enlightenment of patient engagement in drug regulation

WU Jingjing'2， ZENG Kaixin'2，YANG Yufeil2， TIAN Mengyan'， DONG Fangzheng'， ZHANG Yimeng'，LI ， MAO Ningying'2（1. School of International Medicine Business， China Pharmaceutical University， Nanjing 2ll98， China； 2. Research Center of National Drug Policy & Ecosystem， China Pharmaceutical University，Nanjing ，China）

ABSTRACTOBJECTIVEToprovide suggestions forimproving the path andsystemconstructionofpatientengagement indrug regulation in China.METHODS Byreviewinginitiatives andexperiences from theUnitedStates（U.S.），EuropeanUnion（EU）， and Japaninpromoting patientengagement，this studysummarizestherolesandcontributions of patientsintheentiredrug regulatory processintermationallyCombining China'scurrent progressandchallengesinpatientengagementspecificproposalsare formulated to refine regulatory pathways andinstitutional systems.RESULTS&CONCLUSIONS Withgrowing global emphasis on patientengagement asaregulatorystrategy，countriesorregions suchastheU.S，EU，andJapanhaveestablishedclear policies，designatedoversightagencies，anddevelopeddiversifiedpathwaysforpatientengagementPatientscontributeto regulatoryprocessesthroughadvisorymeetings，directdecision-makingrolesandleveraginglivedexperiencesandexpertiseto optimize drugevaluationandmonitoringIncontrast，China's patientengagementremainsprimarilylimitedtoclinicalvalueorienteddrug development，lackingformalpolicyguidance.ItisrecommendedthatChina，basedonitsexisting policysystem， furtherstrengthentheconstructionofasafeguardsystemforpatientengagementimprovethecapacitybuildingandpathwaymodels for patient participationin pharmaceuticalregulation，and promotethecontinuous developmentof patient engagementin pharmaceutical regulation in our country.

KEYWORDS patient engagement； drug regulation； international experience； pathway； enlightenment

随着现代医学对个性化医疗和全流程人文关怀的逐渐重视，在疾病的临床诊断与治疗过程中，患者群体的真实感受愈发重要，“患者参与”的理念也被提出并受到重视，患者在药物监管中的参与作用逐渐被认可。（剩余13013字）