PMDA update: the current situation and future directions
Journal Title: Generics and Biosimilars Initiative Journal - Year 2013, Vol 2, Issue 1
Abstract
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.
Authors and Affiliations
Yuki Ando, Toshiyoshi Tominaga, Tatsuya Kondo
Keywords
Related Articles
- EP ID EP355107
- DOI 10.5639/gabij.2013.0201.013
- Views 109
- Downloads 0
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