In need for a modern Daedalus? The challenging regulatory path for marketing gene therapy medicinal products in China and Europe

Abstract : This article highlights the regulatory challenges of the assessment process of Gene Therapy Medicinal Products. It also addresses the puzzling institutional maze that influences the regulatory path for the marketing of these products as shown through various examples in the European Union and in China.
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https://halshs.archives-ouvertes.fr/halshs-01938345
Contributor : Aurélie Mahalatchimy <>
Submitted on : Wednesday, November 28, 2018 - 3:49:19 PM
Last modification on : Monday, April 29, 2019 - 4:51:56 PM

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Aurélie Mahalatchimy, Anne-Marie Duguet, Wen Meng, Heidi Howard, Anne Cambon-Thomsen, et al.. In need for a modern Daedalus? The challenging regulatory path for marketing gene therapy medicinal products in China and Europe. Q. Yanping, A.-M. Duguet. Biotechnology Medicine and Law, China University of Political Science and Law Press, 2018, 978-7-5620-8420-4. ⟨halshs-01938345⟩

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