New Japanese Initiatives on Stem Cell Therapies

被引：103

作者：

Konomi, Kenji ^{[1
]}

Tobita, Morikuni ^{[1
]}

Kimura, Kenichi ^{[1
]}

Sato, Daisaku ^{[2
]}

机构：

[1] Minist Hlth Labour & Welf, Hlth Policy Bur, Res & Dev Div, Chiyoda Ku, Tokyo 1008916, Japan

[2] Pharmaceut & Med Devices Agcy, Chiyoda Ku, Tokyo 1000013, Japan

来源：

CELL STEM CELL | 2015年 / 16卷 / 04期

关键词：

D O I：

10.1016/j.stem.2015.03.012

中图分类号：

Q813 [细胞工程];

学科分类号：

摘要：

Two laws aiming to provide a new legal framework to promote regenerative medicine, while ensuring the efficacy and safety of the treatments, came into effect in Japan on November 25, 2014. The scope of these laws is briefly described here.

引用

页码：350 / 355

页数：3

共 9 条

[1]

[Anonymous], AD PATHW

[2]

[Anonymous], 2013, NATURE, V494, P5

[3] Letter campaign sought to pressure FDA action on stem cell clinics [J].

Dolgin, Elie .

NATURE MEDICINE, 2014, 20 (08) :796-797

[4] Adaptive Licensing: Taking the Next Step in the Evolution of Drug Approval [J].

Eichler, H-G ;

Oye, K. ;

Baird, L. G. ;

Abadie, E. ;

Brown, J. ;

Drum, C. L. ;

Ferguson, J. ;

Garner, S. ;

Honig, P. ;

Hukkelhoven, M. ;

Limn, J. C. W. ;

Lim, R. ;

Lumpkin, M. M. ;

Neil, G. ;

O'Rourke, B. ;

Pezalla, E. ;

Shoda, D. ;

Seyfert-Margolis, V. ;

Sigal, E. V. ;

Sobotka, J. ;

Tan, D. ;

Unger, T. F. ;

Hirsch, G. .

CLINICAL PHARMACOLOGY & THERAPEUTICS, 2012, 91 (03) :426-437

[5]

Food and Drug Administration, ACC APPR

[6] New Governmental Regulatory System for Stem Cell-Based Therapies in Japan [J].

Hara, Akinori ;

Sato, Daisaku ;

Sahara, Yasuyuki .

THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2014, 48 (06) :681-688

[7]

MHLW, 2014, REP PAT REG SYST REG

[8]

PMDA, SUMM PMDAS MIDT PLAN

[9] Japan stem-cell trial stirs envy [J].

Reardon, Sara ;

Cyranoski, David .

NATURE, 2014, 513 (7518) :287-288

← 1 →