Response to Nature's editorial regarding the Japanese legal system for regenerative medicines

被引：6
|
作者：
Sato, Daisaku [1 ]
Arakawa, Yuji [2 ]
Isobe, Soichiro [2 ]
机构：
[1] Pharmaceut & Med Devices Agcy, Chiyoda Ku, 3-3-2 Kasumigaseki, Tokyo 1000013, Japan
[2] Minist Hlth Labour & Welf, Pharmaceut Safety & Environm Hlth Bur, Med Device & Regenerat Med Prod Evaluat Div, Chiyoda Ku, 1-2-2 Kasumigaseki, Tokyo 1008916, Japan
来源：
REGENERATIVE THERAPY | 2016年 / 4卷
关键词：
Regenerative medicine; Marketing authorization; Legal system; APPROVAL;
D O I：
10.1016/j.reth.2016.04.003
中图分类号：
Q813 [细胞工程];
学科分类号：
摘要：
Nature's editorial, dated 10 December 2015, made several criticisms of the new Japanese conditional and time-limited marketing authorization system for regenerative medical products. We believe these comments were based on a misunderstanding of the purpose of the regulations, which are patient-oriented, offering patients access to promising regenerative medicines in a timely manner at reasonable expense while also ensuring the efficacy and safety of the medicines. The new regulatory system represents an attempt by Japan to accommodate unmet medical needs, particularly for life-threatening diseases, and is in line with current global regulatory trends to enable early patient access to new therapies. (C) 2016, The Japanese Society for Regenerative Medicine. Production and hosting by Elsevier B.V.
引用
收藏
页码：103 / 104
页数：2
相关论文
共 25 条
123