·1281·药品评价DrugEvaluation2022,19(21)·药事管理·科学技术发展对药品监管科学的影响及启示涂明珠1,聂淑华2,夏红英1,葛渟2,高菁3,刘小辉41.江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029;2.江西省药品检查员中心,江西南昌330029;3.江西省药品监督管理局,江西南昌330029;4.江西省医疗器械检测中心,江西南昌330006[摘要]科学技术是药品监管科学得以兴起和蓬勃发展的强大动力和基础。该文对监管科学的起源和科学技术对监管科学发展的影响进行了回顾和分析,探索科技发展与药品监管之间的内在联系,提出相关看法和建议,以期为监管科学研究者提供参考和思路。[关键词]监管科学;药品监管;科学技术;药品;新兴技术DOI:10.19939/j.cnki.1672-2809.2022.21.01TheInfluenceandInspirationoftheDevelopmentofScienceandTechnologyonDrugRegulatoryScienceTUMingzhu1,NIEShuhua2,XIAHongying1,GETing2,GAOJing3,LIUXiaohui41.JiangxiInstituteforDrugControl,NMPAKeyLaboratoryofQualityEvaluationofTraditionalChinesePatentMedicine,JiangxiProvinceEngineeringResearchCenterofDrugandMedicalDeviceQuality,NanchangJiangxi330029,China;2.JiangxiDrugInspectionCenter,NanchangJiangxi330029,China;3.JiangxiProvincialDrugAdministration,NanchangJiangxi330029,China;4.JiangxiCenterofMedicalDeviceTesting,NanchangJiangxi330006,China.[Abstract]Scienceisapowerfuldrivingforceandfoundationfortheriseandvigorousdevelopmentofdrugsupervisionscience.Thispaperreviewsandanalyzestheoriginofregulatoryscienceandtheinfluenceofscienceandtechnologyonthedevelopmentofregulatoryscience,inordertoclarifytherelationshipbetweenthemandthegreatroleofscienceandtechnologyintheriseanddevelopmentofregulatoryscience.Explorestheinternalrelationshipbetweenthedevelopmentofscienceandtechnologyanddrugsupervision,andputsforwardrelevantviewsandsuggestions,inordertoprovidereferenceandideasforresearchersofdrugsupervisionscience.[KeyWords]Regulatoryscience;Drugsupervision;Scienceandtechnology;Drugs;Emergingtechnology基金项目:江西省药品监督管理局科研项目(2020GL01)作者简介:涂明珠,硕士,主管药师。研...