Regulatory

Biosimilar regulation and approval in Jordan

Published in: Volume 7 / Year 2018 / Issue 2
Author(s): , ,
Page: 77-8

Abstract: The regulatory oversight of medicinal products in Jordan is the responsibility of the Jordan Food and Drug Administration (JFDA). In 2015, JFDA adopted biosimilar guidelines, which are similar to… Read More »

Regulation of copy biologicals in China

Published in: Volume 7 / Year 2018 / Issue 2
Author(s):
Page: 75-6

Abstract: The first draft guidelines for copy biologicals were introduced in China back in 2014. The Technical Guideline was then updated and finalized in 2015. In this paper, how the Drug Registration Regulation… Read More »

Regulations for biotherapeutics approval in Colombia

Published in: Volume 7 / Year 2018 / Issue 1
Author(s): ,
Page: 26-8

Abstract: Colombia is in the process of implementing legislation to allow for the approval of biosimilar products so that they can enter the Colombian market. Three regulatory pathways for the… Read More »

Regulatory Science Ireland: bridging the information gap on biosimilar medicines

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

Author byline as per print journal: Joan O’Callaghan, BSc Pharm; Sean Barry, PhD; Una Moore, PhD; Margaret Bermingham, PhD; J Michael Morris, PhD; Frank Hallinan, PhD; Brendan T Griffin, PhD Abstract: Regulatory… 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 »

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