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Title: China's legal framework for pharmaceutical products: challenges and opportunities for EU companies

Authors: Pamela Lattanzi; Federica Monti; Zhao Xu

Addresses: Department of Law, University of Macerata, 2, Piaggia della Torre – Macerata, Italy ' Department of Political Science, Communication and International Relations, University of Macerata, 22, Via Don Minzoni – Macerata, Italy ' Department of Sciences, East China University of Political Science and Law, 575, Wanhangdu Rd – Shanghai, China

Abstract: It is unanimously recognised in the literature that although the Chinese pharmaceutical market offers huge opportunities to European industry, it poses several challenges regarding compliance with the laws governing this sector. Because of the different legal traditions, a peculiar public health history and culture, and a different system of healthcare, EU companies have faced many barriers in accessing the Chinese pharmaceutical market over the years. In order to provide a better understanding of the China's regulatory landscape and its emerging trends, the article focuses on three critical legal topics, which are relevant for the business of EU pharmaceutical companies in the Chinese market: drug registration, drug distribution system, and IP rights protection.

Keywords: China; drug registration; imported drug; new drug; generic drug; pharmaceutical distribution; wholesale; retail; pharmaceutical manufacture; cross border sales; patent; trademark; trade secret; foreign investment.

DOI: 10.1504/IJHTM.2017.087595

International Journal of Healthcare Technology and Management, 2017 Vol.16 No.1/2, pp.128 - 154

Received: 04 Mar 2016
Accepted: 22 Nov 2016

Published online: 17 Oct 2017 *

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