摘要
以日本罕用药制度为参考蓝本,在系统解析日本罕用药制度的基础上,从审批前资格认证、审批上市过程以及上市后监管等方面剖析日本罕用药制度,并对其进行评价。研究表明,日本较为完备的一套罕用药制度收效甚好,有效地促进了罕用药的研发及其可及性的提高,由此为我国罕用药制度的构建提供借鉴意义和理论依据。
With Japan as the target for reference and on the basis of systematic analysis of orphan drug regime in Japan, this paper analyzed orphan drug regime in Japan from the aspects of pre-approval designation, approving and marketing phase and post-marketing administration, and also provided the corresponding operating performance evaluation. The study results indicated that the mature orphan drug system in Japan has yielded good effects in that it has effectively facilitated orphan drug R＆D and improved the access, thereby providing referable and valuable theoretical foundation for the construction of orphan drug regime in China.
出处
《中国药科大学学报》
CAS
CSCD
北大核心
2014年第1期118-124,共7页
Journal of China Pharmaceutical University
基金
国家社会科学基金资助项目(No.13BFX120)~~
