GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 2 / Year 2013 / Issue 1
Regulatory
PMDA update: the current situation and future directions
Author(s): Yuki Ando, BA, Toshiyoshi Tominaga, PhD, Tatsuya Kondo, MD, PhD
Page: 41-4Abstract: 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 […]