Regulatory
US state legislation on biosimilars substitution
Abstract: Despite the fact that US Food and Drug Administration has yet to receive a biosimilars application, many US states have been considering legislation which could potentially limit biosimilars substitution.… Read More »
PMDA update: the current situation and future directions
Published in: Volume 2 / Year 2013 / Issue 1
Author(s): 1 Yuki Ando, BA, 2 Toshiyoshi Tominaga, PhD, 3 Tatsuya Kondo, MD, PhD
Page: 41-4
Author(s): 1 Yuki Ando, BA, 2 Toshiyoshi Tominaga, PhD, 3 Tatsuya Kondo, MD, PhD
Page: 41-4
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… Read More »
Tighter EU rules on pharmacovigilance for biologicals
Received: 27 March 2012; Accepted: 22 May 2012 The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as… Read More »