GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative

Volume 7 / Year 2018 / Issue 2

Regulatory

Biosimilar regulation and approval in Jordan

Author(s): Hayel Obeidat, MD, Rana Musa Ali Al-ali “Malkawi”, MSc, Wesal Salem Al-haqaish, BPharm

Page: 77-8

Author byline as per print journal: Rana Musa Ali Al-ali “Malkawi”, MSc; Wesal Salem Al Haqaish, BPharm; Hayel Obeidat, MD 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 those used by the European […]

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Regulation of copy biologicals in China

Author(s): GaBI Journal Editor

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 (2007) pathway classifies therapeutic biologicals and the principles and challenges of the copy biologicals guideline are described. Submitted: 3 May 2018; Revised: […]

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Last update: 15/06/2018

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