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

Aurélie Mahalatchimy (1, 2) , Anne-Marie Duguet (3) , Wen Meng (4) , Heidi Carmen Howard (3) , Anne Cambon-Thomsen (3) , Emmanuelle Rial-Sebbag (5)

1 DICE - Droits International, Comparé et Européen
2 DICE / CERIC - Droits International, Comparé et Européen / Centre d'études et de recherches internationales et communautaires (CERIC)
3 LEASP - Epidémiologie et analyses en santé publique : risques, maladies chroniques et handicaps
4 Shandong University
5 INSERM - Institut National de la Santé et de la Recherche Médicale

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.

Domaines: Droit

Aurélie Mahalatchimy, Anne-Marie Duguet, Wen Meng, Heidi Carmen 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⟩