患者參與藥物監(jiān)管的國際經(jīng)驗與啟示

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中圖分類號R95 文獻標(biāo)志碼A 文章編號 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

隨著現(xiàn)代醫(yī)學(xué)對個性化醫(yī)療和全流程人文關(guān)懷的逐漸重視，在疾病的臨床診斷與治療過程中，患者群體的真實感受愈發(fā)重要，“患者參與”的理念也被提出并受到重視，患者在藥物監(jiān)管中的參與作用逐漸被認(rèn)可。（剩余13013字）