“Dual-track regulatory” models for regenerative medicine in Japan and the Republic of Korea and their implications for China

YANG Yifan; XIE Jinping; SHAO Rong

doi:10.6039/j.issn.1001-0408.2025.15.02

您当前的位置：

首页 >

文章列表页 >

“Dual-track regulatory” models for regenerative medicine in Japan and the Republic of Korea and their implications for China

更新时间：2025-08-08

- “Dual-track regulatory” models for regenerative medicine in Japan and the Republic of Korea and their implications for China
- ZHONGGUO YAOFANG Vol. 36, Issue 15, Pages: 1832-1836(2025)
- 作者机构：
  
  中国药科大学药品监管科学研究院，南京　211198
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2025.15.02
  CLC： R95
- Received：02 January 2025，
  
  Revised：22 June 2025，
  
  Accepted：23 June 2025，
  
  Published：15 August 2025
- 稿件说明：
移动端阅览
杨伊凡,谢金平,邵蓉.日韩再生医学“双轨制”监管模式介绍及对我国的启示 ^Δ[J].中国药房,2025,36(15):1832-1836.

YANG Yifan,XIE Jinping,SHAO Rong.“Dual-track regulatory” models for regenerative medicine in Japan and the Republic of Korea and their implications for China[J].ZHONGGUO YAOFANG,2025,36(15):1832-1836.
杨伊凡,谢金平,邵蓉.日韩再生医学“双轨制”监管模式介绍及对我国的启示 ^Δ[J].中国药房,2025,36(15):1832-1836. DOI： 10.6039/j.issn.1001-0408.2025.15.02.

YANG Yifan,XIE Jinping,SHAO Rong.“Dual-track regulatory” models for regenerative medicine in Japan and the Republic of Korea and their implications for China[J].ZHONGGUO YAOFANG,2025,36(15):1832-1836. DOI： 10.6039/j.issn.1001-0408.2025.15.02.

摘要

目的

为完善我国细胞与基因治疗产品、疗法的监管提供参考和建议。

方法

系统梳理日本和韩国对再生医学产品、疗法的“双轨制”监管框架，总结二者的有益经验并探索形成对我国监管工作的优化建议。结果与

结论

日本和韩国针对“再生医学产品的注册临床试验”和“再生医学疗法的临床研究”两个路径均建立了清晰的管理流程，并遵循“风险分级”和“全过程管理”的共性思路。据此，建议我国完善顶层立法，明确细胞与基因治疗产品、疗法的监管范畴；厘清各部门的监管职责，提升监管的科学性；合理把握监管尺度，坚持规范和激励并重，加速再生医学产品的临床转化。

Abstract

OBJECTIVE

To provide references and recommendations for improving the regulatory framework for cell and gene therapy products and treatments in China.

METHODS

This study systematically examined the “dual-track regulatory” frameworks for regenerative medicine products and treatments in Japan and the Republic of Korea， summarized their beneficial experiences， and explored optimization strategies for China’s regulatory practices.

RESULTS &

CONCLUSIONS

Both Japan and the Republic of Korea have established clear management processes for two distinct pathways “registered clinical trials for regenerative medicine products” and “clinical research on regenerative medicine treatments” guided by shared principles of “risk stratification” and “full lifecycle oversight”. Based on these findings， it is recommended that China： strengthen top-tier legislative framework to explicitly delineate the regulatory scope governing cell and gene therapy products and treatments； clarify the jurisdictional responsibilities of relevant regulatory bodies to enhance oversight efficacy； appropriately calibrate the regulatory scope， and adopt a balanced regulatory approach that harmonizes standardization with innovation incentives， thereby accelerating the clinical translation of regenerative medicine products.

关键词

Keywords

references

赵培培，温宝书 . 国内外细胞和基因治疗药品监管研究 [J ] . 中国药物警戒， 2024 ， 21 （ 9 ）： 1 - 7 .

CAI Y X ， SUI L J ， WANG J J ， et al . Post-marketing surveillance framework of cell and gene therapy products in the European Union，the United States，Japan，South Korea and China：a comparative study [J ] . BMC Med ， 2024 ， 22 （ 1 ）： 421 .

中共中央办公厅，国务院办公厅 . 关于进一步完善医疗卫生服务体系的意见 [EB/OL ] .（ 2023-03-23 ）[ 2024-09-30 ] . https：//www.gov.cn/zhengce/2023-03/23/content_5748063.htm https://www.gov.cn/zhengce/2023-03/23/content_5748063.htm .

戴书缙 . 我国干细胞产业政策的现状、问题及对策研究 [D ] . 上海：上海交通大学， 2016 .

马洁，刘彩霞，谭琴，等 . 细胞产品质量控制与质量管理 [J ] . 药物评价研究， 2021 ， 44 （ 2 ）： 273 - 292 .

HARA A ， SATO D ， SAHARA Y . New governmental regulatory system for stem cell-based therapies in Japan [J ] . Ther Innov Regul Sci ， 2014 ， 48 （ 6 ）： 681 - 688 .

PMDA . Reviews and related services [EB/OL ] .[ 2024-09-30 ] . https：//www.pmda.go.jp/english/review-services/reviews/0001.html https://www.pmda.go.jp/english/review-services/reviews/0001.html .

PMDA . List of approved products [EB/OL ] .[ 2024-09-30 ] . https：//www.pmda.go.jp/english/review-services/reviews/approved-information/0002.html https://www.pmda.go.jp/english/review-services/reviews/approved-information/0002.html .

NRMD . 关于再生医疗等的数据登记系统介绍 [EB/OL ] .[ 2024-09-30 ] . https：//www.nrmd.jp/ https://www.nrmd.jp/ .

MFDS . 先进再生医学和先进生物制品安全和支持法 [EB/OL ] .（ 2019-08-27 ）[ 2024-09-30 ] . https：//elaw.klri.re.kr/eng_mobile/viewer.do hseq=56486&type=sogan&key=10 https://elaw.klri.re.kr/eng_mobile/viewer.dohseq=56486&type=sogan&key=10 .

KDCE . 2021年先进再生医学与先进生物制品实施计划 [EB/OL ] .[ 2024-09-30 ] . https：//www.kdca.go.kr/board/board.esmid=a20501000000&bid=0015&list_no=713567 &cg_code=&act=view&nPage=1 https://www.kdca.go.kr/board/board.esmid=a20501000000&bid=0015&list_no=713567&cg_code=&act=view&nPage=1 .

KIM D S ， BAE S . Impact and challenges of enactment for advanced regenerative medicine in South Korea [J ] . Front Bioeng Biotechnol ， 2022 ， 10 ： 972865 .

Views

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Research on the supply guarantee system of orphan drugs in South Korea from the perspective of accessibility and its enlightenment

Related Author

YANG Yifan

XIE Jinping

WENG Tingting

YAN Liyu

SHAO Rong

Related Institution

Research Center of National Drug Policy & Ecosystem， China Pharmaceutical University

Address：8th Floor, Sihuan Building, No. 129 Daping Main Street, Yuzhong District, Chongqing, China Postal code：400042
Technical support is provided by Beijing Founder Electronics co., LTD 渝ICP备15012710号公网安备50010302001817
It is recommended to read the content of this site in Chrome&IE9+. Please switch to extreme mode in browser 360.
Cookies We use cookies to help provide and enhance our service and tailor content. By continuing, you agree to the use of cookies.

⁰