Regulatory
Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges
Author(s): 1 Ally Pen, PhD, Agnes V Klein, MD, DPH, Jian Wang, MD, PhD
Page: 36-41
Abstract: Biologicals have offered a new avenue for targeting therapy to treat life-threatening and chronic diseases. The recent or pending patent expirations of many successful biologicals have permitted the marketing… Read More »
Regulation of biologicals in Malaysia
Author(s): Arpah Abas, BPharm, Yvonne Siew Khoon Khoo, BPharm (Hons) MMedSc, PhD (Pharmacology)
Page: 193-8
Abstract: The regulatory oversight of biologicals in Malaysia is established by the National Pharmaceutical Control Bureau (NPCB), Ministry of Health. At the agency, the Section on Biotechnology Product Registration exercises… Read More »
Comparison of biosimilars guidelines
Abstract: This paper provides a detailed comparison of biosimilars guidelines issued in Canada, the European Union, Japan and Korea; and by the World Health Organization (WHO). This comparison highlights the… Read More »
Biosimilar development and regulation in Japan
Abstract: In Japan, biosimilars guidelines following the principles of the EU framework were established by Japan’s Ministry of Health, Labor and Welfare in March 2009. The guidelines cover the manufacturing… Read More »
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
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 »
Regulatory pathway for approval of ‘biosimilars’ in Iran
Abstract: Iran was the first country in the MENA (Middle East and North Africa) region to publish a legal framework for the registration of biosimilars. This framework is defined by… Read More »