日韩再生医学“双轨制”监管模式介绍及对我国的启示
中图分类号R95 文献标志码A 文章编号 1001-0408(2025)15-1832-05DOI 10.6039/j.issn.1001-0408.2025.15.02
“Dual-track regulatory” models for regenerative medicine in Japan and the Republic of Korea and their implications for China
YANGYifan，XIE Jinping，SHAO Rong(Institute of Regulatory Science for Medical Products，China Pharmaceutical University，Nanjing 211198，China)
ABSTRACTOBJECTIVEToprovidereferencesandrecommendations forimprovingtheregulatoryframeworkforcelland gene therapyproductsandtreatmentsinChina.METHODSThisstudysystematicallexaminedthe“dualtrackregulatory”frameworks forregenerativemedicine productsandtreatmentsinJapanandtheRepublicofKorea，summarized theirbeneficialexperiences， and exploredoptimization strategies for China’sregulatory practices.RESULTSamp; CONCLUsIONS Both Japanandthe Republic ofKoreahaveestablishedclearmanagementprocesesfortwodistinctpathways“registeredclinicaltrialsforregenerativemedicine products”and“clinicalresearchonegenerativemedicinetreatments”guidedbysharedprinciplesof“riskstraification”and“ful lifecycleoversight\".Basedontesefindings，itisecommendedtatChina：strengthentoptierlegislativeframeworktoexplicitly delineatetheregulatoryscope governingcellandgene therapyproductsandtreatments；clarifythe jurisdictionalresponsibilitiesof relevantregulatorybodiestoenhanceoversighteficacy；appropriatelycalibratetheregulatoryscope ......
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