摘要
对日本和韩国干细胞监管体系、监管框架和干细胞药品审批方式进行详细的文献回顾和深入分析。韩国和日本的干细胞药品监管法律法规体系健全,监管较为科学,审批上均采取了特殊路径。我国应尽快建立健全干细胞领域的法律法规,完善监管框架,对干细胞药品给予快速或特殊的审批路径,并加强干细胞产品监管与干细胞技术管理的国际交流与合作。
A detailed review and in-depth analysis of Japanese and South Korean stem cell regulatory system and framework and the way of the approval of stem cell drugs. The regulatory laws of South Korean and Japanese stem cell drug are complete,the supervision is reasonable,and the approvals of stem cell drugs are taken a special path. China should improve the legal regulation and establish the regulatory framework of stem cell field as soon as possible,adopting fast or special approval paths for stem cell drugs and strengthen the international communication and cooperation of stem cell technology management.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2018年第3期267-272,共6页
Chinese Journal of New Drugs
基金
国家社会科学基金重大专项资助项目(15ZDB167)
关键词
干细胞药品
日本
韩国
审批
监管
stem cell drugs
Japan
South Korea
approval
supervision
