Regulatory

Regulatory Science Ireland: bridging the information gap on biosimilar medicines

Published in: Volume 5 / Year 2016 / Issue 4
Author(s): , , , , , ,
Page: 168-70

Abstract: Regulatory Science Ireland (RSI) is a voluntary network of interested parties from academia, the Health Products Regulatory Authority (HPRA), pharmaceutical and medical device industries and government agencies. RSI is… Read More »

The EU is ready for non-biological complex medicinal products

Published in: Volume 5 / Year 2016 / Issue 1
Author(s): ,
Page: 30-5

Abstract: This paper describes the existing European Union legislation and scientific guidance to adequately assess the quality, safety and efficacy, as well as the lifecycle management, of the group of… Read More »

Pricing of biosimilars in Saudi Arabia

Published in: Volume 5 / Year 2016 / Issue 1
Author(s): , , ,
Page: 27-9

Author byline as per print journal: Ali M Alhomaidan, PhD; Ibrahim A Aljuffali, MSc, PhD; Fahad S Alnutaifi, MHEcon, MPH; Nasseruddeen A AL-Howaimel, MSc Abstract: Innovation in the pharmaceutical industry… Read More »

Regulatory requirements for the development and registration of biosimilars in South Africa

Published in: Volume 4 / Year 2015 / Issue 3
Author(s): , ,
Page: 150-2

Abstract: In South Africa, medicines are registered and regulated in terms of the Medicines and Related Substances Control Act (Act 101 of 1965), as amended, and the regulations to this… Read More »

Korean regulations for biosimilars

Published in: Volume 4 / Year 2015 / Issue 2
Author(s):
Page: 93-4

Abstract: Regulations for biosimilars in the Republic of Korea have been in place since 2009. Since then, the country has also put in place specific guidelines and approved four biosimilars.… Read More »

Update on US state legislation on biosimilars substitution

Published in: Volume 4 / Year 2015 / Issue 2
Author(s):
Page: 95-7

Abstract: Since the biosimilars pathway was introduced, many US states have been considering, or have introduced, legislation to allow for substitution of biosimilars deemed interchangeable. This paper gives an update… Read More »

Health Canada’s perspective on the clinical development of biosimilars and related scientific and regulatory challenges

Published in: Volume 4 / Year 2015 / Issue 1
Author(s): , ,
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

Published in: Volume 3 / Year 2014 / Issue 4
Author(s): ,
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

Published in: Volume 3 / Year 2014 / Issue 1
Author(s):
Page: 36-8

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

Published in: Volume 2 / Year 2013 / Issue 4
Author(s):
Page: 207-8

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 »

Page 1 of 2 1 2 Next »
Go Back Print