PMDA update: the current situation and future directions

被引：3
|
作者：
Ando, Yuki [1 ]
Tominaga, Toshiyoshi [1 ]
Kondo, Tatsuya [2 ]
机构：
[1] PMDA, Off Int Programs, Chiyoda Ku, Shin Kasumigaseki Bldg,3-3-2 Kasumigaseki, Tokyo 1000013, Japan
[2] Pharmaceut & Med Devices Agcy, Chiyoda Ku, Tokyo 1000013, Japan
来源：
GABI JOURNAL-GENERICS AND BIOSIMILARS INITIATIVE JOURNAL | 2013年 / 2卷 / 01期
关键词：
Approval review; international strategy; Japanese regulatory authority; PMDA; regulatory science; safety measure;
D O I：
10.5639/gabij.2013.0201.013
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
The Pharmaceuticals and Medical Devices Agency (PMDA) is a Japanese drug regulatory agency, sharing responsibilities with the Ministry of Health, Labour and Welfare. Its mission is to protect the public health by assuring safety, efficacy and quality of pharmaceuticals and medical devices. This paper introduces PMDA's current situation (until spring 2012) including its organisational structure, status of product review and safety measures, regulatory science, and international activities.
引用
收藏
页码：41 / 44
页数：4
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